Merck said yesterday that is corrected the study that led to the withdrawal of Vioxx, but that it didn't change the results of the the Approve Study.
Merck said this does not change the Approve results: That use of Vioxx increased the risk of blood clot-related heart attacks after 18 months of continuous treatment.
The source of this article is from Money.com, which you can read by going here.
Wednesday, May 31, 2006
Tuesday, May 30, 2006
Celebrex Case Continued
The case set for trial in State Court in Alabama that was set for June of 2006 has been continued. It has not been reset.
More later.
More later.
Friday, May 26, 2006
Memorial Day Off Topic: Do You Run?
Happy Memorial Day weekend to all. For me, Memorial Day means taking my mind off of legal and the office, and it also means four days of running, in addition to honoring those who served. I prefer trail running which can not always be the easiest thing to do in Atlanta, GA.
On long weekends, I spend time running in a NPS forest known as Sope Creek. This is a trail that has from 3 to 12 miles of tree shaded running and cycling. The lower portion of the trail is loaded with daily runner and walkers. On any given weekend, you may see 500 of more people using the area most call "Columns Drive" or simply "The River." Once you leave the lower trails, it may be that you see 1 or 2 people at most.
Pics of what I see each time are below. I've seen an eagle, wild turkeys, a fox (I think) and it's all just about 30 minutes from where I live. There's a family cemetery deep in the forest that has headstones from the 1850's. Water crossings, mud and silence are parts of each run.
I'll post pics later this weekend.
If you're a runner and have a favorite place to unwind after a day riding the wave of paper on your desk, tell me about it.
On long weekends, I spend time running in a NPS forest known as Sope Creek. This is a trail that has from 3 to 12 miles of tree shaded running and cycling. The lower portion of the trail is loaded with daily runner and walkers. On any given weekend, you may see 500 of more people using the area most call "Columns Drive" or simply "The River." Once you leave the lower trails, it may be that you see 1 or 2 people at most.
Pics of what I see each time are below. I've seen an eagle, wild turkeys, a fox (I think) and it's all just about 30 minutes from where I live. There's a family cemetery deep in the forest that has headstones from the 1850's. Water crossings, mud and silence are parts of each run.
I'll post pics later this weekend.
If you're a runner and have a favorite place to unwind after a day riding the wave of paper on your desk, tell me about it.
An End to Fen Phen ?
Drug maker Wyeth is ready to distribute nearly $1.3 billion to nearly 40,000 people who took Fen Phen. Some know that the fund is called the 7th Amendment fund, which covers various claimants After appeals were completed, fund became final this month.
Funds should be paid out through the fall.
My firm has been investigating and litigating Fen Phen claims since 2000. For those that heard about the litigation, I commend to your reading a book titled "Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen" which you of course can find at Amazon.com
It's a fast read, compelling and shocking.
Funds should be paid out through the fall.
My firm has been investigating and litigating Fen Phen claims since 2000. For those that heard about the litigation, I commend to your reading a book titled "Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen" which you of course can find at Amazon.com
It's a fast read, compelling and shocking.
Wednesday, May 24, 2006
Bone and Tissue Scandal: MDL Hearing 5/25/06
The JPML will hear argument on 5/25 in Kansas City, Missouri regarding Regeneration Technologies Inc.'s MDL Petition. RTI would like to establish an MDL in New Jersey and have approximately a half dozen cases transferred.
Several will argue that the infected bone and tissue cases filed and to be filed should be addressed in an MDL in South Florida.
You can expect other states to be presented during this hearing. I am opposed to an MDL at this juncture in the investigation and litigation of the scandal, but see it down the road.
Most infected bone and tissue claims may likely be made in New York given the information obtained to date, but you may see claims from Minnesota, Oklahoma, Wahsington and Texas as the scandal continues.
For more information go to www.bonescandal.com
Several will argue that the infected bone and tissue cases filed and to be filed should be addressed in an MDL in South Florida.
You can expect other states to be presented during this hearing. I am opposed to an MDL at this juncture in the investigation and litigation of the scandal, but see it down the road.
Most infected bone and tissue claims may likely be made in New York given the information obtained to date, but you may see claims from Minnesota, Oklahoma, Wahsington and Texas as the scandal continues.
For more information go to www.bonescandal.com
Motion to Limit Qualification of Jurors
This just worked for me. Needless to say Defense counsel was not happy. I have filed this Motion in the last half dozen cases, and a Judge just ruled in my favor:
PLAINTIFF’S MOTION TO LIMIT QUALIFICATION OF JURORS
Plaintiff files the following Motion and states:
Plaintiff respectfully requests that the Court, during the course of the questioning of any veniremen, prohibit the Defendant or the Court itself from asking any potential juror if he or she can be “fair” in deliberations of the pending matter.
Plaintiff submits that a venireman cannot be the judge of his or her own fairness. Asking a juror a question of whether or not he/she is “fair” will in each instance result in a “yes” answer. Insistence upon asking a venireman such a question will ultimately result in the denial of an opportunity to exercise a challenge for cause, if such an issue arises. The use of a “fairness” question will thus result in the denial of a right to trial by jury of one’s peers. Curry v. State, 336 S.E.2d 762 (Ga. 1985).
**I don't use any other cases, and argue common sense. If anyone else uses it and has success with it, please let me know.
PLAINTIFF’S MOTION TO LIMIT QUALIFICATION OF JURORS
Plaintiff files the following Motion and states:
Plaintiff respectfully requests that the Court, during the course of the questioning of any veniremen, prohibit the Defendant or the Court itself from asking any potential juror if he or she can be “fair” in deliberations of the pending matter.
Plaintiff submits that a venireman cannot be the judge of his or her own fairness. Asking a juror a question of whether or not he/she is “fair” will in each instance result in a “yes” answer. Insistence upon asking a venireman such a question will ultimately result in the denial of an opportunity to exercise a challenge for cause, if such an issue arises. The use of a “fairness” question will thus result in the denial of a right to trial by jury of one’s peers. Curry v. State, 336 S.E.2d 762 (Ga. 1985).
**I don't use any other cases, and argue common sense. If anyone else uses it and has success with it, please let me know.
Benzene: News Regarding Additional Defendants
Coca-Cola and Cadbury Schweppes are set to be sued in Florida regarding allegations that several of drinks created by each may have contained benzene, fiften years after they pledged to fix the problem.
The Florida lawsuit clainms that independent lab tests found Fanta Orange Pineapple contaminated with benzene at 4.7 times the five parts per billion limit for benzene in USA's drinking water.
The Florida lawsuit says that the companies should have known about the potential for benzene to form in drinks containing benzoates and Vitamin C.
Benzene exposure has serious health effects. Breathing very high levels of benzene can result in death, while high levels can cause drowsiness, dizziness, rapid heart rate, headaches, tremors, confusion, and unconsciousness. Eating or drinking foods containing high levels of benzene can cause vomiting, irritation of the stomach, dizziness, sleepiness, convulsions, rapid heart rate, and death.
The major effect of benzene from chronic (long-term) exposure is to the blood. Benzene damages the bone marrow and can cause a decrease in red blood cells, leading to anemia. It can also cause excessive bleeding and depress the immune system, increasing the chance of infection. {See Wikipedia, here}
Read more here.
The Florida lawsuit clainms that independent lab tests found Fanta Orange Pineapple contaminated with benzene at 4.7 times the five parts per billion limit for benzene in USA's drinking water.
The Florida lawsuit says that the companies should have known about the potential for benzene to form in drinks containing benzoates and Vitamin C.
Benzene exposure has serious health effects. Breathing very high levels of benzene can result in death, while high levels can cause drowsiness, dizziness, rapid heart rate, headaches, tremors, confusion, and unconsciousness. Eating or drinking foods containing high levels of benzene can cause vomiting, irritation of the stomach, dizziness, sleepiness, convulsions, rapid heart rate, and death.
The major effect of benzene from chronic (long-term) exposure is to the blood. Benzene damages the bone marrow and can cause a decrease in red blood cells, leading to anemia. It can also cause excessive bleeding and depress the immune system, increasing the chance of infection. {See Wikipedia, here}
Read more here.
Tuesday, May 23, 2006
Do NSAIDs Lead to Heart Failure?
Nonsteroidal anti-inflammatories (NSAIDs) may be associated with a thirty percent increased risk in older patients of first hospital admission for heart failure, a U.K. study reported in the journal Heart.
NSAIDs are used to treat pain in many types of medical conditions. Several NSAIDs are available without a doctor's prescription ("over the counter" or OTC medications). These include aspirin, low dose (200 mg) ibuprofen (Advil, Motrin, Nuprin,), and low dose naproxen (Aleve). Most claim that NSAIS are safe medications for the vast majority of patients taking them in appropriate doses. Other NSAIDs are only available with a doctor's prescription.
The study of people aged 60 to 84 found that a previous diagnosis of (1)obesity, 2)heart failure (3)cigarette smoking history, and (3)A history of recent in-patient stays and specialist appointments, were tied to an increase in the likelihood of admission to a hospital for heart failure for the first time. The time frame covered was a four year period.
According to the study, of those admitted to any medical facility fourteen percent took one or more NSAIDs upon admission to any facility. This compared with ten percent of a comparison group of randomly selected people. Nearly fifty percent of those who checked in to any hospital were between the ages of 70 to 79.
Of all the NSAIDs, indomethacin (indocin) was associated with an allegedly higher risk. Those who took that drug were three times more likely to be admitted to hospital than people who did not take indomethacin. Osteoarthritis was the most common reason why people took NSAIDs.
Those who wrote the study stated that for every 1,000 people aged 60 to 84 who took any NSAID one extra first hospital admission for heart failure was found.
The study also found that there may be an increase of three additional cases per 1,000 people among patients aged 70 and older with conditions such as diabetes, high blood pressure or kidney failure.
You can read more from this source: Here.
NSAIDs are used to treat pain in many types of medical conditions. Several NSAIDs are available without a doctor's prescription ("over the counter" or OTC medications). These include aspirin, low dose (200 mg) ibuprofen (Advil, Motrin, Nuprin,), and low dose naproxen (Aleve). Most claim that NSAIS are safe medications for the vast majority of patients taking them in appropriate doses. Other NSAIDs are only available with a doctor's prescription.
The study of people aged 60 to 84 found that a previous diagnosis of (1)obesity, 2)heart failure (3)cigarette smoking history, and (3)A history of recent in-patient stays and specialist appointments, were tied to an increase in the likelihood of admission to a hospital for heart failure for the first time. The time frame covered was a four year period.
According to the study, of those admitted to any medical facility fourteen percent took one or more NSAIDs upon admission to any facility. This compared with ten percent of a comparison group of randomly selected people. Nearly fifty percent of those who checked in to any hospital were between the ages of 70 to 79.
Of all the NSAIDs, indomethacin (indocin) was associated with an allegedly higher risk. Those who took that drug were three times more likely to be admitted to hospital than people who did not take indomethacin. Osteoarthritis was the most common reason why people took NSAIDs.
Those who wrote the study stated that for every 1,000 people aged 60 to 84 who took any NSAID one extra first hospital admission for heart failure was found.
The study also found that there may be an increase of three additional cases per 1,000 people among patients aged 70 and older with conditions such as diabetes, high blood pressure or kidney failure.
You can read more from this source: Here.
NYT Article on Vioxx and Why The Data Differs
It's worth signing up for the New York Times to read the recent weekend article regarding the data recently released. The article is titled, "Vioxx Data Suggest Risks Started Earlier."
I posted on that subject last week, which you can read here.
I posted on that subject last week, which you can read here.
Monday, May 22, 2006
Contaminated Bone and Tissue Update
From New York, to Austin, Texas, to Atlanta, GA the scandal continues.
A key figure in this scandal is Dr. Michael Mastromarino, who was a New Jersey oral surgeon who agreed in 2002 to the suspension of his license to practice dentistry in New York state. Four days later, the New York state Department of Health granted him licenses to operate human tissue banks in Brooklyn. Mastromarino also registered his company with the U.S. Food and Drug Administration.
Here is what we have learned form the FDA records and state records, open to all:
*The FDA does not conduct background checks on owners or operators of tissue banks, nor does it lay out any minimum qualifications or standards.
* New York State requires tissue bank applicants to provide information about their background, including arrests and professional misconduct, and requires the Health Department to consider the "character and competence" of bank owners and operators. But Matromarino did not disclose his problems and state officials did not check.
* Regulators conducted no inspections of Biomedical's facility during its first year and inspections afterwards failed to detect practices that regulators now allege were fraudulent and unsafe.
The FDA also issued findings in late January that indicated:
*Eight cases where company records included false statements about a donor's age or cause of death;
*There cases in which the records misstated where tissue recovery was done;
*Six cases where BTS did not disclose that a donor had been hospitalized;and
*Two cases that listed a fictitious spouse on a consent form;
A key figure in this scandal is Dr. Michael Mastromarino, who was a New Jersey oral surgeon who agreed in 2002 to the suspension of his license to practice dentistry in New York state. Four days later, the New York state Department of Health granted him licenses to operate human tissue banks in Brooklyn. Mastromarino also registered his company with the U.S. Food and Drug Administration.
Here is what we have learned form the FDA records and state records, open to all:
*The FDA does not conduct background checks on owners or operators of tissue banks, nor does it lay out any minimum qualifications or standards.
* New York State requires tissue bank applicants to provide information about their background, including arrests and professional misconduct, and requires the Health Department to consider the "character and competence" of bank owners and operators. But Matromarino did not disclose his problems and state officials did not check.
* Regulators conducted no inspections of Biomedical's facility during its first year and inspections afterwards failed to detect practices that regulators now allege were fraudulent and unsafe.
The FDA also issued findings in late January that indicated:
*Eight cases where company records included false statements about a donor's age or cause of death;
*There cases in which the records misstated where tissue recovery was done;
*Six cases where BTS did not disclose that a donor had been hospitalized;and
*Two cases that listed a fictitious spouse on a consent form;
Sereboff: Additional Information as to this decision
The comments below are from the SCOTUS blog:
Counsel for Sereboff argued that Knudson imposed a strict “tracing requirement” on all recoveries – i.e., that the funds the plan sought to recover must be directly traceable to those the plan had advanced.
Justice Roberts, however, distinguished between an “equitable lien sought as a matter of restitution” and an “equitable lien imposed by agreement.” Only the former requires strict tracing. The Sereboffs had argued that an equitable lien could not be imposed by agreement in a case such as theirs, because when the beneficiary agrees to such a provision “‘no third-party recovery’ exists which the beneficiary ‘can place … beyond his control and grant [the fiduciary] a complete and present right therein.’”
Justice Roberts concluded that, under long-standing Supreme Court precedent, the fund over which the lien is asserted need not be in existence when the contract containing the lien provision is executed. Thus, for a plan fiduciary to obtain recovery, as a threshold matter the plan document (as well as, presumably, the summary plan description) must clearly obligate the participant to reimburse the plan from specifically identifiable funds. Notably, Justice Roberts began his opinion by quoting the plan provision in question.
Sereboff argued before the Court that, if the participant receives less than a full recovery, the relief cannot be characterized as “truly equitable.” These objections were brushed aside in this case on another basis. The Court, however, declined to consider the question of whether the equitable relief the fiduciary sought was “appropriate,” as the statute requires, on the basis that it had not been timely raised.
It is not clear whether the existence of the agreement (the plan provision governing the “Acts of Third Parties”) is sufficient in and of itself to create an equitable lien established by agreement, or whether the equitable lien was permitted by the fact that the District Court approved a stipulation by the parties agreeing to preserve a specified amount in an investment account until the District Court ruled on the merits and all appeals were exhausted. The key aspect of the Court’s reasoning in the case was based on the fact that the plan fiduciary sought:
“[S]pecifically identifiable” funds that were “within the possession and control of the Sereboffs”—that portion of the tort settlement due Mid Atlantic under the terms of the ERISA plan, set aside and “preserved [in the Sereboffs’] investment accounts.”
The potential arguments and factual distinctions are readily apparent in situations where a segregated investment account does not exist or where the participant does not continue to hold the money."
Counsel for Sereboff argued that Knudson imposed a strict “tracing requirement” on all recoveries – i.e., that the funds the plan sought to recover must be directly traceable to those the plan had advanced.
Justice Roberts, however, distinguished between an “equitable lien sought as a matter of restitution” and an “equitable lien imposed by agreement.” Only the former requires strict tracing. The Sereboffs had argued that an equitable lien could not be imposed by agreement in a case such as theirs, because when the beneficiary agrees to such a provision “‘no third-party recovery’ exists which the beneficiary ‘can place … beyond his control and grant [the fiduciary] a complete and present right therein.’”
Justice Roberts concluded that, under long-standing Supreme Court precedent, the fund over which the lien is asserted need not be in existence when the contract containing the lien provision is executed. Thus, for a plan fiduciary to obtain recovery, as a threshold matter the plan document (as well as, presumably, the summary plan description) must clearly obligate the participant to reimburse the plan from specifically identifiable funds. Notably, Justice Roberts began his opinion by quoting the plan provision in question.
Sereboff argued before the Court that, if the participant receives less than a full recovery, the relief cannot be characterized as “truly equitable.” These objections were brushed aside in this case on another basis. The Court, however, declined to consider the question of whether the equitable relief the fiduciary sought was “appropriate,” as the statute requires, on the basis that it had not been timely raised.
It is not clear whether the existence of the agreement (the plan provision governing the “Acts of Third Parties”) is sufficient in and of itself to create an equitable lien established by agreement, or whether the equitable lien was permitted by the fact that the District Court approved a stipulation by the parties agreeing to preserve a specified amount in an investment account until the District Court ruled on the merits and all appeals were exhausted. The key aspect of the Court’s reasoning in the case was based on the fact that the plan fiduciary sought:
“[S]pecifically identifiable” funds that were “within the possession and control of the Sereboffs”—that portion of the tort settlement due Mid Atlantic under the terms of the ERISA plan, set aside and “preserved [in the Sereboffs’] investment accounts.”
The potential arguments and factual distinctions are readily apparent in situations where a segregated investment account does not exist or where the participant does not continue to hold the money."
Ketek (Antibiotic): Link to Liver failure?
The FDA reports that the antibiotic Ketek may be linked to twelve cases of liver failure (including four deaths). The FDA recommends that Sanofi-Aventis adds a warning label to the drug's packaging.
Ketek was approved by the FDA in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.
The FDA conclusion relates to a May 16, 2006 memorandum the FDA's Division of Drug Risk Evaluation. There had been information posted by the FDA in January of 2006 which you can read here.
To the shock of no one, the company has stated in a release that it continues to believe that Ketek is safe and effective when used as directed.
Sources include the WSJ print edition, AP, and Yahoo.
Ketek was approved by the FDA in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.
The FDA conclusion relates to a May 16, 2006 memorandum the FDA's Division of Drug Risk Evaluation. There had been information posted by the FDA in January of 2006 which you can read here.
To the shock of no one, the company has stated in a release that it continues to believe that Ketek is safe and effective when used as directed.
Sources include the WSJ print edition, AP, and Yahoo.
Wednesday, May 17, 2006
Merck's Nifty Site Re: Vioxx Litigation
Thanks to Evan Schaeffer and Legal Underground for alerting me and others to this site from Merck: LearnaboutVioxx.com
Evan surmises that the site was possibly designed by defense attorneys for Merck. What do you think?
Evan surmises that the site was possibly designed by defense attorneys for Merck. What do you think?
Tuesday, May 16, 2006
ERISA, The Sereboff Decision, and a Work Around?
The decision by SCOTUS yesterday in Sereboff in my view makes the job even more difficult for lawyers who work with injured consumers.
A few comments:
Prior to settlement, my office always tries to negotiate with the health insurer or its agent. Most insurers now use recovery services such as Rawlings, and I do find it is easier to settle with them.
The Sereboff decision refers to "identifiable funds" in the possession of the beneficiary. Should any settlement check be made payable to the attorney and client, and thus not be considered solely identifiable to the plan beneficiary?
In the opinion Roberts declined to consider that the injured claimants could raise equitable defenses to the claim of lien, such as the made whole doctrine because “this distinct assertion” wasn’t raised in the lower court. I face this issue on catastrophic injuries with limited insurance.
It may that ATLA’s amicus brief may give you guidance in the event that suit is filed against your client. ATLA encouraged the Court to consider a theory of “Equitable Reimbursement” which would also include provision for payment of attorneys fees and costs.
If you have thoughts about how you may handle ERISA claims in the post Sereboff world, drop me a note.
A few comments:
Prior to settlement, my office always tries to negotiate with the health insurer or its agent. Most insurers now use recovery services such as Rawlings, and I do find it is easier to settle with them.
The Sereboff decision refers to "identifiable funds" in the possession of the beneficiary. Should any settlement check be made payable to the attorney and client, and thus not be considered solely identifiable to the plan beneficiary?
In the opinion Roberts declined to consider that the injured claimants could raise equitable defenses to the claim of lien, such as the made whole doctrine because “this distinct assertion” wasn’t raised in the lower court. I face this issue on catastrophic injuries with limited insurance.
It may that ATLA’s amicus brief may give you guidance in the event that suit is filed against your client. ATLA encouraged the Court to consider a theory of “Equitable Reimbursement” which would also include provision for payment of attorneys fees and costs.
If you have thoughts about how you may handle ERISA claims in the post Sereboff world, drop me a note.
Monday, May 15, 2006
ERISA Decision by SCOTUS 5/12/06
In Sereboff v. MidAtlantic Medical Services the Court has held that plan fiduciaries under the Employment Retirement Income Security Act can bring a civil action under Section 502(a)(3) of the act to obtain "appropriate equitable relief" to recover money that plan participants received from another source.
You can find the decision here.
You can find the decision here.
Vioxx in the Wall Street Journal Again, Page 1
How the New England Journal Missed Warning Signs on Vioxx is the title of the article. The article refers to a radio show whose guest was Jeffrey Drazen at that time the top editor of the New England Journal of Medicine. The WSJ article refers to an audio exchange, and you can find it by going here.
It's in Real Audio format. A pharmacist calls in to the show and asks why NEJM had not commented on Vioxx in 2001.
It's in Real Audio format. A pharmacist calls in to the show and asks why NEJM had not commented on Vioxx in 2001.
Vioxx: Is Risk Reduced After Use Ends?
My Friday May 12, 2006 post referred to data released May 11, 2006 by Merck. The same day and the next, headlines touted different conclusions.
The battle that now lays ahead is from the APPROVe study. The study found that patients taking Vioxx during the first three years of the study had a 92% higher risk of stroke and heart attack than those taking an inactive placebo pill.
The "preliminary" data released indicates that in the year after stopping Vioxx, 1,721 patients had a 74% higher stroke/heart attack risk. During that year, 28 patients who had taken Vioxx -- and 16 patients who had taken placebo pills -- had a stroke or heart attack. Most of these events were strokes.
According to various Merck employees' statement, the difference is not statistically significant, meaning it could be a chance finding. Merck says this means there isn't any risk to people who stop taking Vioxx -- at least, no scientifically proven risk.
According to a report on Webmc.com however:This is not so. Steve Nissen, MD, interim chairman of the department of cardiovascular medicine at The Cleveland Clinic has said: "What this means is the relative risk of an event with Vioxx, even after the drug was stopped, was very similar to the risk while taking the drug."
"It has profound implications for patients. It means that patients who previously took Vioxx must be followed closely and must be made aware of their increased risk."
Another doctor said, "I would say the numbers are small, but they suggest an ongoing risk from Vioxx in those who stopped taking it. There appears to be this same increase in risk as seen while taking the drug. While the difference is not statistically significant, it is concerning." (Per Michael Farkouh, MD).
"This suggests Vioxx has more than a [blood-clot-promoting] effect," he says. "It suggests more is going on with this drug than we thought. I would say it is possible it causes persistent damage to the arteries."
You can read more from this well done report by going here.
The battle that now lays ahead is from the APPROVe study. The study found that patients taking Vioxx during the first three years of the study had a 92% higher risk of stroke and heart attack than those taking an inactive placebo pill.
The "preliminary" data released indicates that in the year after stopping Vioxx, 1,721 patients had a 74% higher stroke/heart attack risk. During that year, 28 patients who had taken Vioxx -- and 16 patients who had taken placebo pills -- had a stroke or heart attack. Most of these events were strokes.
According to various Merck employees' statement, the difference is not statistically significant, meaning it could be a chance finding. Merck says this means there isn't any risk to people who stop taking Vioxx -- at least, no scientifically proven risk.
According to a report on Webmc.com however:This is not so. Steve Nissen, MD, interim chairman of the department of cardiovascular medicine at The Cleveland Clinic has said: "What this means is the relative risk of an event with Vioxx, even after the drug was stopped, was very similar to the risk while taking the drug."
"It has profound implications for patients. It means that patients who previously took Vioxx must be followed closely and must be made aware of their increased risk."
Another doctor said, "I would say the numbers are small, but they suggest an ongoing risk from Vioxx in those who stopped taking it. There appears to be this same increase in risk as seen while taking the drug. While the difference is not statistically significant, it is concerning." (Per Michael Farkouh, MD).
"This suggests Vioxx has more than a [blood-clot-promoting] effect," he says. "It suggests more is going on with this drug than we thought. I would say it is possible it causes persistent damage to the arteries."
You can read more from this well done report by going here.
Friday, May 12, 2006
Vioxx: Heart Attack After Discontinuing Use Does AND Does Not Have An Effect
Clear as mud, right? In the WSJ today, the headline reads: Merck Study Finds A Vioxx Risk After Use Ended. If you went online, however, to read more about this development, you will find this article online:
"Study Finds Vioxx Users Not at Higher Risk of Heart Attack, Stroke in Year After Stopping Drug," which you can find here.
So which is it? Is the AP correct? WSJ? In a Reuters article, there was this comment:
The company followed patients for another year as part of the original APPROVe study design to assess possible health consequences for those no longer taking the drug.
Merck said 28 Vioxx patients had adverse heart events compared with 16 in the placebo group. That study is the one known as: Adenomatous Polyp Prevention with VIOXX.
Looking at the data and information released yesterday right now. Once digested, I should be able to post it here in PDF format.
"Study Finds Vioxx Users Not at Higher Risk of Heart Attack, Stroke in Year After Stopping Drug," which you can find here.
So which is it? Is the AP correct? WSJ? In a Reuters article, there was this comment:
The company followed patients for another year as part of the original APPROVe study design to assess possible health consequences for those no longer taking the drug.
Merck said 28 Vioxx patients had adverse heart events compared with 16 in the placebo group. That study is the one known as: Adenomatous Polyp Prevention with VIOXX.
Looking at the data and information released yesterday right now. Once digested, I should be able to post it here in PDF format.
Meridia Appellate Decision: Daubert Excludes Expert Testimony
Th never ending litigation involving Meridia had an issue rendered by the Sixth Circuit Appeals Court on May 11, 2006. Meridia is a drug that is prescribed to treat obesity.
The appellate decision affirmed a lower court decision to exclude a pharmacologist's opinion that the elevation in blood pressure caused by Meridia outweighed any health benefits.
Go here to read the PDF opinion.
More later after I have had a chance to digest it.
The appellate decision affirmed a lower court decision to exclude a pharmacologist's opinion that the elevation in blood pressure caused by Meridia outweighed any health benefits.
Go here to read the PDF opinion.
More later after I have had a chance to digest it.
Catch my Podcast on Legal Broadcast Network
If you haven't spent time checking out the Legal Broadcast Network and your practice has a personal injury litigation emphasis, you should. I did give credit to Dave Swanner and his blog at sctriallaw.com; Dave is the one who motivated me to start this blog.
On LBN, you can find podcasts that include an interview with noted brain injury lawyer Michael V. Kaplen, among others.
Yesterday Mark Wahlstrom from LBN decided that I would be a good guest for his weekly show/podcast. He wrote on his own blog:
I've posted a podcast with Attorney Mark Zamora who is the blogger and attorney who authors the "A Georgia Lawyer" blog. Attorney Zamora is from Decatur, GA and has an interesting practice, with part of it being a local personal injury practice, but another aspect of it being a national practice focusing on defective drug litigation.
Mark and I discussed how he got started blogging, some of the benefits of being a regional attorney who speaks to a national audience, and how his expertise in defective drug litigation is starting to bring him national contacts and attention thanks to his diligent expansion of his blog.
A very interesting 18 minutes for trial lawyers, planners and others to listen and hear what he's learned, where he hopes to go with it, and also more about Attorney Zamora's practice and the cases he is working on. Hopefully he will be a regular guest as we go forward.
You can find the podcast here.
On LBN, you can find podcasts that include an interview with noted brain injury lawyer Michael V. Kaplen, among others.
Yesterday Mark Wahlstrom from LBN decided that I would be a good guest for his weekly show/podcast. He wrote on his own blog:
I've posted a podcast with Attorney Mark Zamora who is the blogger and attorney who authors the "A Georgia Lawyer" blog. Attorney Zamora is from Decatur, GA and has an interesting practice, with part of it being a local personal injury practice, but another aspect of it being a national practice focusing on defective drug litigation.
Mark and I discussed how he got started blogging, some of the benefits of being a regional attorney who speaks to a national audience, and how his expertise in defective drug litigation is starting to bring him national contacts and attention thanks to his diligent expansion of his blog.
A very interesting 18 minutes for trial lawyers, planners and others to listen and hear what he's learned, where he hopes to go with it, and also more about Attorney Zamora's practice and the cases he is working on. Hopefully he will be a regular guest as we go forward.
You can find the podcast here.
Thursday, May 11, 2006
Plaintiffs seek MDL Re: Bausch and Lomb
Several Plaintiffs have asked the Judicial Panel on Multidistrict Litigation to create a Bausch & Lamb ReNu contact lens solution MDL.
Petitons were filed April 28, 2006. They claim that actions regarding injury, consumer claims, and medical monitoring, as to ReNu® MoistureLoc Contact Lens Solution should be transferred and consolidated.
Suggested sites are: The U.S. District Courts for the Western District of Louisiana, the Southern District of Florida and the Eastern District of New York as the most appropriate venues.
The Issues relating to the contact lens soltuion are:
On April 10, the FDA and the CDC alerted healthcare professionals and their patients of the increasing number of reports of the rare but serious fungal eye infection, which can cause blindness. Three days later, Bausch & Lomb requested that U.S. retailers stop selling ReNu. The FDA issued a statement on April 14 supporting the company’s decision to temporarily withdraw its product, the plaintiffs say, noting that symptoms of fungal keratitis include eye pain and discomfort, vision loss and light hypersensitivity.
Petitons were filed April 28, 2006. They claim that actions regarding injury, consumer claims, and medical monitoring, as to ReNu® MoistureLoc Contact Lens Solution should be transferred and consolidated.
Suggested sites are: The U.S. District Courts for the Western District of Louisiana, the Southern District of Florida and the Eastern District of New York as the most appropriate venues.
The Issues relating to the contact lens soltuion are:
On April 10, the FDA and the CDC alerted healthcare professionals and their patients of the increasing number of reports of the rare but serious fungal eye infection, which can cause blindness. Three days later, Bausch & Lomb requested that U.S. retailers stop selling ReNu. The FDA issued a statement on April 14 supporting the company’s decision to temporarily withdraw its product, the plaintiffs say, noting that symptoms of fungal keratitis include eye pain and discomfort, vision loss and light hypersensitivity.
Infected Bone and Tissue: Oregon
This article is from Oregon.com:
Oregon doctors have contacted their patients after the FDA issued a recall for stolen bone that had not yet been used and encouraged physicians to inform their patients who already had received implants. Bone that had been implanted in patients such as Dawes was left in place. In that state, no patients have become ill with any disease that can be traced to the stolen bone according to the Oregon Department of Human Services.
The DHS reports that it is unknown how many Oregonians may have received stolen bone or tissue. Medical privacy laws with stiff financial penalties make hospitals reluctant to share information that might be used to identify a patient. Three Jackson County hospitals received notice of the recall from Medtronic, a bone distributor that received its material from one of the five companies that originally acquired the bone from Biomedical Tissue Services.
Oregon doctors have contacted their patients after the FDA issued a recall for stolen bone that had not yet been used and encouraged physicians to inform their patients who already had received implants. Bone that had been implanted in patients such as Dawes was left in place. In that state, no patients have become ill with any disease that can be traced to the stolen bone according to the Oregon Department of Human Services.
The DHS reports that it is unknown how many Oregonians may have received stolen bone or tissue. Medical privacy laws with stiff financial penalties make hospitals reluctant to share information that might be used to identify a patient. Three Jackson County hospitals received notice of the recall from Medtronic, a bone distributor that received its material from one of the five companies that originally acquired the bone from Biomedical Tissue Services.
Wednesday, May 10, 2006
Katrina: 22 Part Series in Atlanta Paper
New Orleans is a City I love, I have written a bit about what has happened there Post-Katrina. I was there during Mardi Gras and just came back from Jazz Fest the weekend of May 6-7, 2006.
You can find prior posts here , here, and here.
This past week the Atlanta Journal began a 22 part series that the paper describes as:" A serial narrative told in 22 daily chapters,[that] reveals what happened inside two hospitals, one private and one public, during the days after the levees broke in New Orleans. It is an intimate portrait of medical professionals who faced unprecedented conditions and acted heroically to keep their patients alive. It is also the tale of daring rescuers who came to the aid of those the government had abandoned."
You can find it here.
The writing to me tends to be a bit overly dramatic. The author tried to combine a novel's features with the reality of what happened. It's early in the series (Part 5 as of today). If you can handle somewhat clumsy writing, it's worth your time.
To say what is happening in LA, MS and AL is a national disgrace is an understatement. Piles of trash nearly six months old sit twelve feet high just two miles east of the Quarter. Trailers are sitting in other states while contractors quibble over who gets to deliver them. Stoplights are still out and there is no power near the Fairgrounds, which is only about three to five miles from the CBD.
The one enduring lesson in all of this? In the event of a national disaster, you are truly on your own. Local, state and federal officials will fail you, so you need to be ready. Not just ready for three days like you read about, but for weeks and months later. I'm angry about it, and you should be too.
You can find prior posts here , here, and here.
This past week the Atlanta Journal began a 22 part series that the paper describes as:" A serial narrative told in 22 daily chapters,[that] reveals what happened inside two hospitals, one private and one public, during the days after the levees broke in New Orleans. It is an intimate portrait of medical professionals who faced unprecedented conditions and acted heroically to keep their patients alive. It is also the tale of daring rescuers who came to the aid of those the government had abandoned."
You can find it here.
The writing to me tends to be a bit overly dramatic. The author tried to combine a novel's features with the reality of what happened. It's early in the series (Part 5 as of today). If you can handle somewhat clumsy writing, it's worth your time.
To say what is happening in LA, MS and AL is a national disgrace is an understatement. Piles of trash nearly six months old sit twelve feet high just two miles east of the Quarter. Trailers are sitting in other states while contractors quibble over who gets to deliver them. Stoplights are still out and there is no power near the Fairgrounds, which is only about three to five miles from the CBD.
The one enduring lesson in all of this? In the event of a national disaster, you are truly on your own. Local, state and federal officials will fail you, so you need to be ready. Not just ready for three days like you read about, but for weeks and months later. I'm angry about it, and you should be too.
UnitedHealth Advice on Cutting Pill Cost: Split them
There is a pilot pill-splitting program run by UnitedHealth Group Inc. that started in Wisconsin last year and has now become a national effort in 2006. The program identifies sixteen drugs that UnitedHealth says are okay to split. The company goes further and gives patients a financial incentive to participate.
Lipitor, for example, costs $299.97 for 90 tablets, regardless of whether the dosage is 20, 40 or 80 milligrams. Go to Drugstore.com to see for yourself.
Included on the list of drugs "suitable" for splitting are Lipitor, Zoloft, Zocor, and Mavik.
As you can imagine, drugmakers don't like this approach. According to the Bloomberg report, splitting pills can be dangerous for certain types of patients and for certain medicines, according to Jeff Trewhitt with Pharmaceutical Research and Manufacturers of America.
To read more, go here.
Lipitor, for example, costs $299.97 for 90 tablets, regardless of whether the dosage is 20, 40 or 80 milligrams. Go to Drugstore.com to see for yourself.
Included on the list of drugs "suitable" for splitting are Lipitor, Zoloft, Zocor, and Mavik.
As you can imagine, drugmakers don't like this approach. According to the Bloomberg report, splitting pills can be dangerous for certain types of patients and for certain medicines, according to Jeff Trewhitt with Pharmaceutical Research and Manufacturers of America.
To read more, go here.
Monday, May 08, 2006
Pfizer broke law with'96 drug trial, Nigeria finds
From NJ.com:
Nigerian medical experts have concluded that Pfizer Inc. violated international law during a 1996 epidemic when the company tested an unapproved drug on children with brain infections, The Washington Post reported.
A Nigerian government report on the panel findings that was never released was recently obtained by the Post. The report was provided by a source who asked to remain anonymous because of personal safety concerns, the newspaper reported yesterday.
The Infectious Diseases Hospital in Kano, Nigeria, was treating meningitis patients in 1996 when Pfizer administered the experimental drug Trovan to children.
Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants, the panel's report concludes. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis.
The panel concluded the experiment violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child.
The panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records showing that Pfizer told the children or their parents that they were part of an experiment, the Post reported.
Five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evi dence the drug played a part. Six children died while taking a comparison drug, the newspaper said.
Pfizer pointed to its earlier statements on the matter, while declining to respond to specific points in the panel report. Pfizer said it acted responsibly.
My comment: One of the reasons I do what I do.
Nigerian medical experts have concluded that Pfizer Inc. violated international law during a 1996 epidemic when the company tested an unapproved drug on children with brain infections, The Washington Post reported.
A Nigerian government report on the panel findings that was never released was recently obtained by the Post. The report was provided by a source who asked to remain anonymous because of personal safety concerns, the newspaper reported yesterday.
The Infectious Diseases Hospital in Kano, Nigeria, was treating meningitis patients in 1996 when Pfizer administered the experimental drug Trovan to children.
Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants, the panel's report concludes. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis.
The panel concluded the experiment violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child.
The panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records showing that Pfizer told the children or their parents that they were part of an experiment, the Post reported.
Five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evi dence the drug played a part. Six children died while taking a comparison drug, the newspaper said.
Pfizer pointed to its earlier statements on the matter, while declining to respond to specific points in the panel report. Pfizer said it acted responsibly.
My comment: One of the reasons I do what I do.
Allstate: From Good Hands to Boxing Gloves?
From Bloomberg:
There is a detailed article about David Berardinelli, a Plaintiffs' lawyer who is set to publish a book titled "From Good Hands to Boxing Gloves." It will apparently tell the story of the key role played by =McKinsey & Co. in reengineering auto insurance claims operations at Allstate Corp.
Read more by going here.
There is a detailed article about David Berardinelli, a Plaintiffs' lawyer who is set to publish a book titled "From Good Hands to Boxing Gloves." It will apparently tell the story of the key role played by =McKinsey & Co. in reengineering auto insurance claims operations at Allstate Corp.
Read more by going here.
Vioxx: Will the Canadian Study (2 Weeks' Use May = MI) Mean More Lawsuits?
According to the Canadian study now online, A quarter of those in that study who suffered an acute MI did so within two weeks of the patient's first Vioxx prescription. This, according to Linda Levesque, a McGill doctoral student in epidemiology and biostatistics, the authoer of that study.
According to an article online: Chris Placitella an attorney investigating Vioxx cases will be looking at the Canadian study.
He said, "It certainly lends support for the plaintiffs' claim that short-term duration use of Vioxx can cause cardiac events. It also will cause us to go back and reevaluate some of the cases we rejected because of very short-term use after we have the opportunity to review the results of the study with our experts." Link.
That same article quotes John Thomas, a health law professor at Quinnipiac University School of Law, in Hamden, Conn. as suggesting that the McGill will probably lead to more lawsuits.
My comment: I don't see it leading to more lawsuits. With less than five months before the statutes of limitations in two year states runs, there simply is not enough time to analyze this study, find the doctors who will help a case, and file a short term use case. By short term I mean less than three months.
According to an article online: Chris Placitella an attorney investigating Vioxx cases will be looking at the Canadian study.
He said, "It certainly lends support for the plaintiffs' claim that short-term duration use of Vioxx can cause cardiac events. It also will cause us to go back and reevaluate some of the cases we rejected because of very short-term use after we have the opportunity to review the results of the study with our experts." Link.
That same article quotes John Thomas, a health law professor at Quinnipiac University School of Law, in Hamden, Conn. as suggesting that the McGill will probably lead to more lawsuits.
My comment: I don't see it leading to more lawsuits. With less than five months before the statutes of limitations in two year states runs, there simply is not enough time to analyze this study, find the doctors who will help a case, and file a short term use case. By short term I mean less than three months.
Medco Settlement of Kickback Charges
Medco Health Solutions Inc. looks like it has been able to settle federal allegations regarding kickbacks, soliciting business, and improperly destroying records for $163 million.
The U.S. Attorney's office in Pennsylvania it accused Medco of soliciting kickbacks from pharmaceutical manufacturers, and paying kickbacks to health plans to obtain business.
Source: Reuters and Yahoo!
The U.S. Attorney's office in Pennsylvania it accused Medco of soliciting kickbacks from pharmaceutical manufacturers, and paying kickbacks to health plans to obtain business.
Source: Reuters and Yahoo!
Wednesday, May 03, 2006
Vioxx: Heart Attacks May Occur after 2 Weeks' Usage
from a Candada study:
A little more than 25% of 240 patients who suffered MI's while on Vioxx had the adverse event within a week to thireetn days after first ingestnig the drug according to a study published online today by the Canadian Medical Association Journal. The research was based on an analysis of thousands of health records in Quebec. You can find the PDF of the article by going here.
From a quote on Bloomberg.com:
``For first-time users you can have an event in as little as two weeks,'' said Linda Levesque, assistant professor of epidemiology at Queen's University in Kingston, Ontario, and the study's lead researcher, in a telephone interview today. ``Now we have evidence that early risk is possible.''
A little more than 25% of 240 patients who suffered MI's while on Vioxx had the adverse event within a week to thireetn days after first ingestnig the drug according to a study published online today by the Canadian Medical Association Journal. The research was based on an analysis of thousands of health records in Quebec. You can find the PDF of the article by going here.
From a quote on Bloomberg.com:
``For first-time users you can have an event in as little as two weeks,'' said Linda Levesque, assistant professor of epidemiology at Queen's University in Kingston, Ontario, and the study's lead researcher, in a telephone interview today. ``Now we have evidence that early risk is possible.''
Tuesday, May 02, 2006
P.I.: Key Decision from SCOTUS - Medicaid Reimbursement
On May 1, 2006 the U.S. Supreme Court rendered a landmark Plaintiff’s rights decision relating to personal injury settlements.
The Court unanimously affirmed the Eighth Circuit’s decision in Arkansas Dept. of Health and Human Services v. Ahlborn.
Find th case here.
In summary, a State’s Medicaid department must be limited to reimbursement from only that portion of a judgment or settlement that represents payment for medical expenses.
States are prohibited from seeking to be reimbursed for Medicaid costs from settlement proceeds that were intended to cover items other than medical expenses paid. Thus, excluded from the claws of Medicaid will be pain and suffering as well as wage loss claims. The Court held that the federal anti-lien statutes serve to prevent States from attaching the non-medical components of any settlement or judgment.
Attorneys for injured consumers should look not only to the negotiation of the amount of any settlement, but consider first any initial classification of damages. You can expect a more thorough discussion of this ruling soon.
“[t]here is no question that the State can require an assignment of the right, or chose in action, to receive payments for medical care. So much is expressly provided for by §§1396a(a)(25) and 1396k(a). And we assume, as do the parties, that the State can also demand as a condition of Medicaid eligibility that the recipient “assign” in advance any payments that may constitute reimbursement for medical costs. To the extent that the forced assignment is expressly authorized by the terms of §§1396a(a)(25) and 1396k(a), it is an exception to the anti-lien provision. See Washington State Dept. of Social and Health Servs. v. Guardianship Estate of Keffeler, 537 U. S. 371, 383–385, and n. 7 (2003). But that does not mean that the State can force an assignment of, or place a lien on, any other portion of Ahlborn’s property. As explained above, the exception carved out by §§1396a(a)(25) and 1396k(a) is limited to payments for medical care. Beyond that, the anti-lien provision applies.” (Emphasis added).
So where are we now? In the U.S. Supreme Court’s own words, States may not demand reimbursement from portions of the settlement allocated or allocable to non-medical damages; instead, States are given only a priority disbursement from the medical expenses portion alone. Prior to this ruling, if, for example, an Arkansas Medicaid recipient settled her entire action against a 3d party for $20,000, and the State (Medicaid Department) paid that amount or more to medical providers on her behalf, nothing in the State statutes would preclude the State from receiving the whole settlement and the recipient would be left with nothing.
The Court unanimously affirmed the Eighth Circuit’s decision in Arkansas Dept. of Health and Human Services v. Ahlborn.
Find th case here.
In summary, a State’s Medicaid department must be limited to reimbursement from only that portion of a judgment or settlement that represents payment for medical expenses.
States are prohibited from seeking to be reimbursed for Medicaid costs from settlement proceeds that were intended to cover items other than medical expenses paid. Thus, excluded from the claws of Medicaid will be pain and suffering as well as wage loss claims. The Court held that the federal anti-lien statutes serve to prevent States from attaching the non-medical components of any settlement or judgment.
Attorneys for injured consumers should look not only to the negotiation of the amount of any settlement, but consider first any initial classification of damages. You can expect a more thorough discussion of this ruling soon.
“[t]here is no question that the State can require an assignment of the right, or chose in action, to receive payments for medical care. So much is expressly provided for by §§1396a(a)(25) and 1396k(a). And we assume, as do the parties, that the State can also demand as a condition of Medicaid eligibility that the recipient “assign” in advance any payments that may constitute reimbursement for medical costs. To the extent that the forced assignment is expressly authorized by the terms of §§1396a(a)(25) and 1396k(a), it is an exception to the anti-lien provision. See Washington State Dept. of Social and Health Servs. v. Guardianship Estate of Keffeler, 537 U. S. 371, 383–385, and n. 7 (2003). But that does not mean that the State can force an assignment of, or place a lien on, any other portion of Ahlborn’s property. As explained above, the exception carved out by §§1396a(a)(25) and 1396k(a) is limited to payments for medical care. Beyond that, the anti-lien provision applies.” (Emphasis added).
So where are we now? In the U.S. Supreme Court’s own words, States may not demand reimbursement from portions of the settlement allocated or allocable to non-medical damages; instead, States are given only a priority disbursement from the medical expenses portion alone. Prior to this ruling, if, for example, an Arkansas Medicaid recipient settled her entire action against a 3d party for $20,000, and the State (Medicaid Department) paid that amount or more to medical providers on her behalf, nothing in the State statutes would preclude the State from receiving the whole settlement and the recipient would be left with nothing.
Tequin (Antiobiotic): Withdrawal from the Market Planned
The antibiotic Tequin is coming off the market. Bristol-Myers Squibb Co. confirmed that it plans to stop making and selling Tequin. Tequin is prescribed for chronic bronchitis, sinusitis, pneumonia, urinary tract and other infections. The drug generated approximately $100 million in sales in the U.S.
The drug was first sold in 1999. Tequin is associated with both high- and low-blood sugar in patients. Two months ago the FDA required increased warnings on Tequin's label. Tequin's maker warnsthat it should not be used by diabetics, the elderly, and those with kidney disease. You can read the Medwatch posting on the FDA site by going here. The posting states:
Posted 02/16/2006] BMS notified FDA and healthcare professionals about proposed changes to the prescribing information for Tequin, including an updating of the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a CONTRAINDICATION for use in diabetic patients. The changes also include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose-altering medications while taking Tequin. The proposed changes are highlighted in the following "Dear Healthcare Provider" letter issued by BMS. Specific wording of these additions and revisions to the labeling is pending FDA review and approval.
Sources include: AP, Yahoo!, Reuters.
The drug was first sold in 1999. Tequin is associated with both high- and low-blood sugar in patients. Two months ago the FDA required increased warnings on Tequin's label. Tequin's maker warnsthat it should not be used by diabetics, the elderly, and those with kidney disease. You can read the Medwatch posting on the FDA site by going here. The posting states:
Posted 02/16/2006] BMS notified FDA and healthcare professionals about proposed changes to the prescribing information for Tequin, including an updating of the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a CONTRAINDICATION for use in diabetic patients. The changes also include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose-altering medications while taking Tequin. The proposed changes are highlighted in the following "Dear Healthcare Provider" letter issued by BMS. Specific wording of these additions and revisions to the labeling is pending FDA review and approval.
Sources include: AP, Yahoo!, Reuters.
Subscribe to:
Posts (Atom)