Tuesday, August 23, 2011

Dangerous Supplement? Pai You Guo Poses Risk


In 2009, the Food and Drug Administration (FDA) announced a voluntary recall of Pai You Guo and issued 
alerts about the supplement's potential health risks.

The new study found nearly a quarter of Brazilian-born women surveyed in Boston use Pai You Guo. No one who took the supplement was aware of the recall, and most experienced side effects.

The article shows once again how ineffective the FDA is when it comes to any recall. Nearly 25% of those women in the study were still using the product. 




Read more: http://www.foxnews.com/health/2011/08/16/dieters-may-unknowingly-buy-dangerous-weight-loss-supplements/#ixzz1VrBaztel

Analysis Continues of Fallout From FDA's SSRI Warning

From Psychiatry Online:



The “black box” warning on antidepressants appears to have affected the likelihood of making an outpatient visit for depression, but not of receiving an antidepressant prescription following a diagnosis of depression.
The number of children's outpatient office visits for depression and visits during which an antidepressant was prescribed dropped in the wake of the 2003 U.S. Food and Drug Administration (FDA) advisory linking an increased risk of suicidality with antidepressant use among pediatric patients.
Yet children diagnosed with depression appeared no less likely to be prescribed antidepressants than before the warning, according to an analysis appearing in the July Psychiatric Services.
Read more at the source:http://pn.psychiatryonline.org/content/46/15/18.1.full

Wednesday, August 10, 2011

Georgia: Actos and Cancer Claims = Lawsuits

From various sources including the  AP and Yahoo.

This summer, Takeda Pharmaceuticals Co. Ltd. stopped sales of Actos in both France and Germany. After that decision  FDA issued warnings about the cancer risk based on new research, but they have allowed sales to continue. 


Doctors are being told not to prescribe Actos for people who have or have had bladder cancer.


In the past week, the first of what lawyers predict will be thousands of lawsuits were filed in courts across the country. It is claimed that Actos triggered bladder cancer, in some cases fatal, in clients who took the pills 

Thursday, August 04, 2011

Georgia High Schools Fail to Protect Players from Oppressive Heat

A guest post from a well respected lawyer in Georgia. I'm angry today. Angry that two high school teenagers died this week while exercising in heat that exceed 100F in some parts of Georgia. The article on these needless deaths is found here:

http://www.ajc.com/sports/high-school/metro-football-coaches-review-1072903.html

Take a read and tell me what you think.


By: Buddy Morrison
Butler, Wooten & Fryhofer, LLP
ColumbusGA



  Football is the South's favorite fall tradition.  While the games are usually played on cool autumn nights, high schools begin their preparation in August, during the most brutal heat of the year.  Unfortunately, practicing this fall sport in the dog days of summer is a dangerous and often deadly mix.  Already this year two Georgia high school students have died from heat exposure during football practice - two deaths that were entirely avoidable and treatable.


Georgia high schools were allowed to begin "mandatory" outdoor football practice on Monday, August 1, in the middle of an oppressive heat wave.  On Tuesday, two Georgia teenagers died after practicing in that heat.  On Tuesday morning, Fitzgerald High School defensive lineman DJ Searcy, 16, died after practice with his team's football camp in Lake CityFlorida.   Later in the evening, Locust Grove High School offensive lineman Forest Jones, 16, died after passing out and spending a week in a coma after a voluntary workout with his team.

These two deaths come on the heels of a report by the CDC that nearly one-fourth of all emergency room visits for heat illness are attributable to football, and that August is the most common month for heat illness to occur.  Over the past fifty years, hundreds of football players have died from heat-related illnesses - with most of those deaths coming in the first couple of days of practice. 

Unfortunately, Georgia schools are not doing nearly enough to protect students.  The Georgia High School Association (GHSA) and its member schools have failed to properly regulate practice in the heat in order to prevent the onset of heat-related illness.  Even after these two recent deaths,Georgia high school coaches are still subjecting children to overexertion in dangerous heat conditions.  Even worse, schools are not taking adequate steps to diagnose heat illness.  Finally, even when heat illness is diagnosed, schools are not taking simple steps that would make death from heat illness entirely preventable.  August football practices at Georgia high schools are unreasonably dangerous. 

In response to Tuesday's deaths, the GHSA shifted responsibility by noting that it requires individual schools to submit their own written policies for practicing football in the heat.  The GHSA has also been conducting a study with Michael Ferrara, Ph.D. at the University of Georgia, to study the relationship between heat levels and heat illness, but that study has not yet been completed.  The GHSA stated that it may implement a uniform heat policy in the future.

The GHSA began requiring heat policies from its member schools five years ago, when a RockdaleCounty football player suffered a heat-related death.  The policies must specify the time of day practices may be held and the amount of time allotted to rest at various heat/humidity levels, as well as set a maximum heat/humidity level where outdoor practices must be terminated.  Essentially, the school must implement a sliding scale related to the heat index - when the heat index is X, practice must start before Y.  When the heat index reaches Z, practice must be canceled altogether or moved indoors.

The "sliding scales" drawn up by the individual schools vary widely from district to district.  Dr. Frerrara noted that "we have seen some policies that have been conservative while others have allowed practice to continue in extreme conditions."  More importantly, the policies do not apply to "voluntary workouts" during the summer - only to "mandatory" workouts.  So long as the players are not required to be at the workout, the coach can hold the workout in any manner he chooses regardless of the heat index.  According to the GHSA, both of the players who died this week were participating in "voluntary workouts" not subject to the GHSA or school regulations.

Even for the "mandatory" practices, including the critical first week of practice beginning August 1, GSHA schools are not required to submit written guidelines for the total amount of time spent practicing, the type of equipment worn, or procedures for diagnosing and treating heat illness. Instead, the GHSA practice rules simply provide that "mandatory" practice may begin on August 1, and that in the first five days of practice, at least two days must have "players dressed in shorts, helmets, shoulder pads, mouthpieces and shoes only."   For the other three days, players may wear full pads.  Further, schools can have "voluntary workouts" at any time, where the players may only wear helmets and mouthpieces. 

The GHSA and its member schools need not apply such a haphazard set of rules - uniform, comprehensive guidelines for practicing football in the summer are not hard to find.  In 2009, the National Athletic Trainers' Association (NATA) issued comprehensive guidelines for beginning football practice that are stricter than even the GHSA practice-time rules.  The NATA recommends that the first two days of practice be helmets-only and that the next three days be limited to helmets and shoulder pads.  The NATA further recommends that an athletic trainer be present at every practice, only one practice per day during the first five days of practice, a maximum of three hours of practice during the first five days, and no consecutive "two-a-days" (two practices in one day) during the second week of football practice. 

It is clear that, even in the wake of these two deaths, some Georgia coaches are not taking the risk of heat illness and death seriously.  This week, Temple High School and West Hall High Schoolkicked off their football camps with three-a-day workouts, and continued doing so even after Tuesday's tragic news.  Schools throughout the state are still conducting two practices a day.   Although many schools, including Atlanta public schools, have canceled outdoor afternoon practices during the heat wave, other schools around the state have not altered their practice plans in response to the oppressive heat. 

Other coaches mistakenly place the responsibility for proper heat acclimatization on the players themselves.  The coach of Mt. Zion High School attributed heat issues to players "laying on their couch all summer."  The coach of Carrolton High School suggested that players participating in the "voluntary workouts" handled the heat better than other players.  (The NATA guidelines call for proper heat acclimatization for all players - even those who do not participate in the "voluntary workouts" throughout the summer.)  Marion County High School actually depended on the voluntary workouts to get players acclimated to the heat.  Coach Mike Swaney observed: "If you let the kids stay home in the air conditioning and let them play video games and watch TV -- if they don't do anything all summer -- they will be in a situation where they'd be in a state of shock to come out in this kind of heat."

Not only are Georgia high schools failing to take adequate measures to prevent heat illness, they are also failing to adequately diagnose and treat symptoms.  Although most coaches now allow players to take a break and rehydrate whenever necessary, "sometimes coaches confuse heat stroke with goofing off, so they push the players harder," said William Roberts, M.D., former president of the American College of Sports Medicine. 

The most effective way to determine if a particular athlete is suffering from heat illness is with a rectal thermometer.  A body temperature of over 104 degrees Fahrenheit is considered to be heat stroke.  High schools are not using the best objective method to diagnose heat stroke.  Depending on the athlete to volunteer that he is experiencing symptoms is not enough - first, athletes often fail to report symptoms to exhibit their "toughness," and second, an elevated core temperature decreases the athlete's cognitive ability and judgment. 

Even when a player does show symptoms of heat illness, teams often fail to take adequate steps to protect their players from further damage.  Water, rest, and shade are not enough.  Death from heat stroke is 100% preventable, but it requires immediate and correct medical attention.  "You have to diagnose [heat stroke] quickly and treat it quickly or a cascade of bad events starts to happen," Dr. Roberts said. Players who show signs of heat illness should be placed in a tub of ice water, which can reduce body temperature from above 108ºF to below 102ºF in 20 to 40 minutes.   Rehydration alone cannot stop heat stroke quickly enough.  According to Douglas Casa, Ph.D., director of athletic training education at the University of Connecticut, if teams kept a "kiddie pool" of ice water available at practices, they could prevent heat-related deaths.  Even in August's sweltering heat, most football teams fail to take this simple precaution.

While heat illness is more prevalent in high school football than other sports, no student-athlete is immune from its effects.  Baseball, soccer, and cheerleading all have their share of heat-related illnesses, as confirmed by the CDC report.  Also during this time of year, the marching band practices alongside the football team in the blazing heat.  Notably, these sports and activities lack even the superficial safeguards that have been implemented for football. 

This week has reminded us that mixing fall football with August heat is a deadly combination.  Unfortunately for Georgia's student-athletes, schools are making football unreasonably dangerous by requiring too much practice in the heat and failing to properly care for players who suffer from heat illness brought on by that over-exertion.  Two sixteen-year-old boys died on Tuesday from a condition that was both 100% avoidable and 100% treatable. 

Tuesday, August 02, 2011

August 2, 2011 Transvaginal Mesh News: Ethicon Gynecare Study


News on the mesh failures continues. 
The Gyncare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems were first brought to market in the fall  of 2005 and Gynecare Prolift+M variations were introduced in  2008. The vaginal mesh or bladder sling is designed reinforce weakened or damaged tissue on the pelvic floor that hold organs in place, such as the bladder, the uterus, the rectum the top of the vagina or the bowel.



A conducted by European researchers suggested that most of the reoperations were due to urinary incontinence that occurred after the mesh was implanted, with other problems including transvaginal mesh complications and prolapse recurrence.
Researchers reviewed the outcomes for 524 patients who received the Ethicon Gynecare Prolift vaginal mesh between January 2005 and January 2009. At a median follow up of 38 months, 11.6% had to undergo reoperation after receiving the Prolift Mesh for pelvic organ prolapse. About 6.9% of those reoperations were due to urinary incontinence, 3.6% due to mesh-related complications and 3% due to recurring prolapse, which the mesh is designed to treat. 
http://www.ajog.org/article/PIIS0002937811009574/fulltext

Antipsychotic Meds Not Effective for Combat PTSD

Worth a read from ABC News.com:


Risperidone, antipsychotic medication normally prescribed to treat symptoms of schizophrenia and bipolar disorder, may not be effective in treating symptoms of chronic post-traumatic stress disorder, according to a study published Tuesday in the Journal of the American Medical Association.

Risperidone is commonly prescribed as an add-on treatment for veterans with the more severe forms of PTSD who do not respond to antidepressants.

FDA calls ‘Lazy Larry’ Brownies Unsafe

The FDA has warned the manufacturer of melatonin-laced brownies called “Lazy Larry” that the government considers them unsafe and could seize them from store shelves.


The brownies contain melatonin. The FDA wrote: We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders




Here is the letter:



The Food and Drug Administration (FDA) has reviewed the regulatory status of your product, “Lazy Larry” (formerly “Lazy Cakes”). Your “Lazy Larry” product is adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 342(a)(2)(C)] because it bears or contains an unsafe food additive. Specifically, it contains melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under section 409 of the FDCA [21 U.S.C. § 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (21 CFR), Part 170. You can find copies of the FDCA and these regulations through links on FDA’s home page at http://www.fda.gov.
 
Your “Lazy Larry” product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321(ff)]. The FDCA excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321(ff)(2)(B)].  Your use of the term “dietary supplement” in the statement of identity and your use of a “Supplement Facts” panel for nutrition labeling do not make your product a dietary supplement, because your “Lazy Larry” product is represented for use as a conventional food. Examples of factors and information that establish that the product is represented as a conventional food are as follows:
 
- the product is marketed alongside snack foods;
- the name of a URL, www.mylazycakes.com (accessed 7-14-11), that directs people to your product website, refers to a conventional food (cake);
- the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;
- the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);
- the appearance and packaging of the product as a brownie.
 

Thursday, July 28, 2011

Intercharm Inc. Issues A Recall Of Slim Forte Slimming Capsules

From the FDA:



 Intercharm Inc., is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Botanical Slimming Soft Gel to the consumer/user level. FDA laboratory analyses found the products to contain Sibutramine an appetite suppressant. Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons.
  • Slim Forte Slimming Capsules is packaged in a green box with a picture of a woman on the front. The box has pink, blue, and green text. The box contains 30 capsules.
  • Slim Forte Slimming Coffee is packaged in a green box with a picture of a woman on the front. The box has pink, blue, and green text. The box contains 10 packets of instant coffee.
  • Meizitang Botanical Slimming Soft Gel is packaged in a green package/pouch with green background and a picture of a woman on front. The package has yellow, white, and black text. The pouch contains 3 blister packs of 12 each 650 mg softgel capsules.

Products containing Sibutramine pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Intercharm Inc. has not received any reports of adverse events related to this recall.

These products are sold as dietary supplements and marketed for weight loss. Slim Forte Slimming Capsule, Batch No. 20100928, Best By 09.27.2012 and Batch No. 20100604, Best By 06.03.2012; Slim Forte Slimming Coffee, Batch No. 20100903, Best By 09.02.2012; and Meizitang Botanical Slimming Soft Gel, Lot Code 12.24.2009, Best By 12.23.2011 are included in this recall. Products were distributed through the internet nationwide and internationally to Ireland.

Consumers should stop using these products immediately and return to the place of purchase. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

Cetero Faked Documents, Claims the FDA


Drug companies that had medicines tested by  a company known as Cetero Research could face product reevaluation - that news according to the FDA after it found that Cetero was faking documents and manipulating samples.
The news is concerning. The FDA report states, "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during a 5 year time frame (April 1, 2005 to June 15, 2010)." Source:  http://www.fda.gov/Drugs/DrugSafety/ucm265561.htm


From the FDA:
The FDA has notified Cetero Research, Houston, Texas (Cetero) of significant violations of federal regulations relating to their conduct of analytical testing of drugs before they are marketed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for pharmaceutical companies; these data are included in New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
In addition, FDA is notifying pharmaceutical companies with applications pending before the Agency that testing conducted by Cetero’s Houston facility between April 2005 and June 2010 will need to be evaluated and possibly redone. Given the nature of Cetero’s violative practices, FDA has concerns that the bioequivalence and bioavailability data generated at the Cetero Houston facility from April 1, 2005 to June 15, 2010 may be unreliable. These data are included in New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) submitted to FDA.
It is unlikely that these concerns relating to data integrity will affect the overall safety and efficacy of drugs already on the market. FDA is taking this precautionary measure to make sure the data underlying the approval decision is completely reliable. At this time,  there is no evidence of problems with the safety, quality, purity or potency of drugs already approved and marketed.

Stay tuned to this story.


Wednesday, July 27, 2011

Meth users have greater risk of developing Parkinson’s

Meth addiction is a national problem.  Methamphetamine is a central nervous system stimulant drug that is similar in structure to amphetamine. Due to its high potential for abuse, methamphetamine is classified as a Schedule II drug and is available only through a prescription that cannot be refilled. Although methamphetamine can be prescribed by a doctor, its medical uses are limited, and the doses that are prescribed are much lower than those typically abused. Most of the methamphetamine abused in this country comes from foreign or domestic superlabs, although it can also be made in small, illegal laboratories, where its production endangers the people in the labs, neighbors, and the environment.

As if the known dangers are not enough, now there is this news:

From Thespec.com: 

Canadian scientists say there’s a link between the abuse of methamphetamines and the development of Parkinson’s disease.


Researchers at the Centre for Addiction and Mental Health in Toronto used medical records for more than 40,000 people in California who had been hospitalized for abusing meth- or amphetamine-like stimulants from 1990 to 2005.

They were compared to records for more than 200,000 people admitted for appendicitis, and more than 35,000 diagnosed with cocaine use disorders. A diagnosis of Parkinson’s was identified from hospital records or death certificates.

The study found that the methamphetamine group had a 76 per cent higher risk of developing Parkinson’s disease.

Here is the source: http://www.thespec.com/living/healthfitness/article/569352--meth-users-have-greater-risk-of-developing-parkinson-s

Certain Antidepressants Linked to Falls in Nursing Homes

From Health Day:

In the days after they start taking non-SSRI (selective serotonin reuptake inhibitor) antidepressants, such as bupropion or venlafaxine, there is a new study suggesting that nursing home residents are at significantly greater risk for falls.

In conducting the study, recently published online in the Journal of Gerontology: Medical Sciences, researchers examined information on 1,181 nursing home residents who had fallen. Specifically, they compared changes in their antidepressant medication one week and two weeks before the fall.

Read more here: http://news.yahoo.com/certain-antidepressants-linked-falls-nursing-homes-181207928.html 

Pfizer’s Zyvox and Antidepressants: A Fatal Combination?

From Bloomberg and the FDA:

The drugZyvox - an antibiotic -- can cause potentially fatal central nervous system reactions in patients who also take antidepressants that increase levels of the brain chemical serotonin, so says the FDA.

The FDA site has this: Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications.

The U.S. Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (marketed as Zyvox®) is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications).    

Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome—signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.

Healthcare professionals and patients may not realize that linezolid has monoamine oxidase inhibitor (MAOI) properties. Linezolid should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with linezolid such as when:
  • Linezolid is used to treat vancomycin-resistant Enterococcus faecium (VRE) infections.
  • Linezolid is used to treat infections such as nosocomial pneumonia and complicated skin and skin structure infections, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).


Read more here: http://www.fda.gov/Drugs/DrugSafety/ucm265305.htm#table

Tuesday, July 26, 2011

July 27/11 News: FDA: Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Last week I  wrote about the recent FDA report regarding TVM failures. Here is the information that has been available in 2008:



Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Recommendations

Physicians should:
  • Obtain specialized training for each mesh placement technique, and be aware of its risks.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.


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Anti Clotting Drug -Severe Bleeding, No Benefit?

heart attack anatomyImage by gandhiji40 via FlickrAdding a new anti-clotting drug, Eliquis, to dual antiplatelet therapy may result in severe bleeding without reducing the risk of heart attack and stroke, according to a new report. 

 A trial evaluating the combination treatment was halted early when the risk of severe bleeding among those taking Eliquis (apixaban) became apparent.

 Link here.
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Thursday, July 21, 2011

Georgia: Transvaginal Mesh Patch Failure News

Transvaginal Mesh Patch Failure

A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:
  • Erosion of the vaginal tissue
  • Infection
  • Bleeding
  • Pain
  • Urinary problems such as incontinence
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation (puncturing) from surgical tools during mesh implantation
Less frequent problems included
  • Return of POP
  • Neuro-muscular problems
  • Vaginal scarring/shrinkage
  • Emotional problems

FDA Alerts and Research Find Transvaginal Patches Unsafe

2011 FDA Alert – Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also finds the risky surgical mesh treatment of POP to be no more effective than traditional treatment.

2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect including:
  • 7 times the risk of bladder perforation
  • Nearly twice the risk of urinary incontinence (loss of bladder control)
  • 3.2 percent of women required follow-up surgery to correct problems
2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.

2010 Study Published – A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.

2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.
Over 200 Lawsuits Filed Already
More than 200 women across the United States have filed lawsuits against three of the makers of transvaginal mesh patches:
  • C.R. Bard
  • Johnson & Johnson’s Ethicon
  • American Medical Systems
Complications have been reported for several other manufacturers of surgical mesh as well including:
  • Boston Scientific Scimmed
  • Sofradim
  • Caldera
  • Mentor Corporation
What Should You Do?
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.

J and J must pay S.C. $327 million

A South Carolina judge has rules that Johnson & Johnson must pay $327 million for deceptive marketing of its Risperdal antipsychotic medication.

Judge Roger Couch chastised the company's management for allowing "the profit-at-all-costs mentality to cloud" their approach to marketing the drug. The letter to doctors, which eventually drew a warning from FDA for false and misleading claims, was a "clever effort" to "manipulate the message" about Risperdal, Couch ruled (as quoted by Bloomberg).


Wednesday, July 20, 2011

Las Vegas: Aria Hotel/Casino Guests & Legionnaires' Disease

Tests from the Centers for Disease Control and Prevention have determined that six former guests of the Aria hotel in Las Vegas' City Center have been diagnosed with Legionnaire's Disease, a form of pneumonia. All of the patrons have recovered, but the disease can sometimes be fatal. Aria officials are notifying guests who stayed at the hotel from June 21 to July 4 that they might have been exposed to the bacteria, and if they feel ill to quickly seek medical attention. 

According to the Las Vegas Review Journal, "Legionella, the bacterium that causes Legionnaires' disease, is often found in air-conditioning cooling towers, whirlpool spas, showers, faucets or other water sources. The bacterium can rapidly reproduce in warm, stagnant waters." The hotel received inspections that determined the bacteria was present in the showers and faucets of numerous rooms. 

From the Aria site:

A message from ARIA:
In cooperation with the Southern Nevada Health District, ARIA Resort is contacting guests who may have stayed with us from June 21 to July 4 at a time when water tests detected elevated levels of Legionella bacteria in several of our guest rooms.
Health officials have recently notified us of a few reported instances of guests who visited ARIA, were diagnosed with, treated for, and recovered from Legionnaires' disease (a form of pneumonia caused by Legionella bacteria). In an abundance of caution, we are attempting to notify guests who may have been exposed to these bacteria during this short period.
ARIA has in place a water treatment program and, once the initial tests were received, we immediately implemented a comprehensive abatement effort. All subsequent tests have come back with no detectable levels of active Legionella.

Seroquel: Label Change because of Heart Risks

From the FDA and other sources:


Seroquel is a drug that is widely prescribed. Also known as Quetiapine, it is used to treat either schizophrenia or bipolar disorder. In those with bipolar it is used for depressive episodes, acute manic episodes associated with bipolar I disorder, and maintenance treatment of bipolar I disorder (as adjunct therapy to lithium or divalproex). 

Last week, this label change:

WARNING:  INCREASED MORTALITY IN ELDERLY PATIENTS WITH 
DEMENTIA-RELATED PSYCHOSIS  

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of seventeen placebocontrolled trials (modal duration of 10 weeks) largely in patients taking
atypical antipsychotic drugs, revealed a risk of death in drug-treated
patients of between 1.6 to 1.7 times the risk of  death in placebo-treated
patients. Over the course of a typical  10-week controlled trial, the rate of
death in drug-treated patients was about 4.5%, compared to a rate of about
2.6% in the placebo group. Although the causes of death were varied, most
of the deaths appeared to be either cardiovascular (e.g., heart failure,
sudden death) or infectious (e.g., pneumonia) in nature.  Observational
studies suggest that, similar to atypical antipsychotic drugs, treatment with
conventional antipsychotic drugs may increase mortality. The extent to
which the findings of increased mortality in observational studies may be
attributed to the antipsychotic drug as opposed to some characteristic(s) of
the patients is not clear.  SEROQUEL (quetiapine) is not approved for the
treatment of patients with dementia-related psychosis [see  Warnings and
Precautions (5.1)]

Tuesday, July 19, 2011

Multaq on the FDA Watch List Again

The post below sets out the drugs on the FDA watch list. Making the list again is  Dronedarone or Multaq. 

Physicians should not stop prescribing these drugs, nor should patients stop taking them, according to the FDA.




In the case of dronedarone, reports of several potential signals of risk reported for 2010 were followed by regulatory action.
  • The AERS watch list for the first quarter of 2010 cited potential signals of congestive heart failure for the drug. On February 22, 2011, the FDA revised the warnings and precautions section of dronedarone's label regarding patients with new or worsening heart failure during treatment to state that postmarketing cases of such problems have been reported. The label had originally stated that there were limited data for patients with atrial fibrillation/atrial flutter who develop worsening heart failure during dronedarone therapy, but nevertheless advised clinicians to consider suspending or discontinuing the drug if heart failure commences or worsens.
  • In the second quarter, AERS identified potential signals of torsade de pointes, a rare kind of ventricular tachycardia.
  • The list for the third quarter of 2010 listed a potential signal for an interaction with warfarin that increases its anticoagulant effect. On March 21, 2011, the drug interactions section of dronedarone's label was changed to mention postmarketing cases of higher internal normalized ratio (INR) clotting times with or without bleeding events in patients taking warfarin. Physicians were advised to monitor INR in such individuals. The label had originally stated that in clinical trials, "there was no observed excess risk for bleeding compared to placebo" when dronedarone was coadministered with oral anticoagulants to patients with atrial fibrillation/atrial flutter, and that INR should be monitored according to the warfarin label.
  • Potential signals of liver failure for dronedarone appeared in the watch list for the last 3 months of 2010. On February 11, 2011, the FDA changed the warnings and precautions section of the label to mention postmarketing cases of hepatocellular liver injury and acute liver failure, and the need to promptly discontinue dronedarone if such an injury is suspected. Other parts of the label were revised accordingly.
For more information, please read the source of this post: http://www.medscape.com/viewarticle/746530
The FDA has published its latest quarterly list of drugs to monitor after having identified potential signs of serious risks or new safety information. The new watch list covers the first 3 months of 2011. Here's the list for 2011 so far: 

Potential Signals of Serious Risks/New Safety Information Identified by AERS, January to March 2011
Product Potential Signal of a Serious Risk/New Safety Information Additional Information (as of May 31, 2011)
Adalimumab (Humira, Abbot Laboratories) Hepatic dysfunction, hepatic failure  
Azathioprine (Imuran, Prometheus) Acute febrile neutrophilic dermatosis (Sweet's syndrome) The label's adverse reactions section was updated in May to include Sweet's syndrome
Cetuximab (Erbitux, Eli Lilly and Bristol-Myers Squibb) Corneal infection, ulcerative keratitis, skin necrosis  
Dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) Labeling for proper storage and handling to preserve potency The FDA issued a safety communication on March 29 reminding users and pharmacies about the correct handling and storage of the drug
Dronedarone HCl (Multaq, Sanofi-Aventis) Renal impairment, renal failure  
Fibrin Sealant (Tisseel VH, Baxter Healthcare; Evicel, Omrix Pharmaceuticals) Graft failure in ophthalmological procedures and lack of efficacy in neurosurgical procedures for repair of dural tears Tisseel VH and Evicel have been used off- label in ophthalmological and neurosurgical procedures as tissue adhesives
Immune Globulin Subcutaneous (Human) 6% Liquid (Vivaglobin, CSL Behring) Thromboembolic adverse events have been reported in association with numerous product lots The product was taken off the market on April 4
Iron sucrose injection (Venofer, Luitpold Pharmaceuticals) Anaphylactic reactions  
Quinolone products Pseudotumor cerebri  
Malathion (Ovide, Taro Pharmaceutical Industries) Burns and burning sensations  
Mercaptopurine (Purinethol, Teva Pharmaceuticals) Hepatosplenic T-cell lymphoma  
Prasugrel HCl (Effient, Eli Lilly) Hypersensitivity reactions  
Rituximab (Rituxan, Roche) Hypogammaglobulinemia  
Ropinirole HCl (Requip, GlaxoSmithKline) Medication errors resulting from similarities in product name and labeling to risperidone