Friday, January 28, 2011

FDA panel backs Bayer imaging drug

Animation of an MRI brain scan, starting at th...Image via WikipediaFrom Reuters:

A Food and Drug Administration advisory panel voted 16-0 in favor of the drug, gadobutrol. The FDA usually follows panel recommendations. A final decision is due by March 14.

Gadobutrol is a stronger version of products in a class called gadolinium-based contrast agents, or GBCAs, used with MRI scans. The drugs carry warnings about the risk of nephrogenic systemic fibrosis (NSF), a potentially fatal skin disorder.

GBCAs with higher NSF risk come with a strong warning that they should not be used in patients with kidney disease, which increases the chances of the skin disorder.

Read more at the source .
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FDA and Triad Alcohol Prep Pads News

Image representing Pfizer as depicted in Crunc...Image via CrunchBaseFrom the FDA this week:

Pfizer Inc. and Progenics Pharmaceuticals, Inc. have learned of a United States market recall of alcohol prep pads and swabs manufactured by the Triad Group. In the interest of patient safety, Pfizer and Progenics are alerting U.S. patients and physicians to Triad’s recall. Triad® Alcohol Prep Pads are packaged for use with the kit presentation of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The RELISTOR vial and other components of the kit are not affected by the defective Triad alcohol pad. RELISTOR sold in single vials also is unaffected by this recall.

Pfizer and Progenics advise patients using the RELISTOR kit not to use the Triad alcohol prep pads included in the RELISTOR packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their RELISTOR injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.

Shipments of RELISTOR kits have been suspended until the alcohol pads can be replaced, which will be done as quickly as possible to enable patients to continue to receive RELISTOR. Triad alcohol prep products are not included in RELISTOR sold as single vials or in RELISTOR kits outside of the United States or with other Pfizer medications.

For more go hereFD. 
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Tuesday, January 25, 2011

More Android Apps for Lawyers

Here is another set of apps for Android not necessarily limited to law based apps:

1.Simply Clock: I use the MIUI Clock/Weather app for my Android HTC, but I also like this one -

2. History Eraser: The app name pretty much sums it up. It will Clean Browser History;  
Clean Call Log; Clean Market Search History; Clean Google Map Search History and
Clean Gmail Search History.

3.Medscape by WebMD:  I work in an area of the law where quite literally each case has medical issues, symptoms, diagnosis or other medical related concerns. I like this app.  It has a comprehensive drug reference, including herbals and supplements; Drug Interaction Checker; Disease & Condition Reference and Treatment Guide ; Procedures Reference, Tables & Protocols Reference, and a Physician, Pharmacy, and Hospital Directory. I really like the  price: Free

4.Camera File AppThis app is a sthat makes it a bit easier to attach a picture to an email directly from the camera. Normally when you want to attach a picture to an email you have already started writing, you have to exit the email app, take the picture, then go back to your email, tap attach, and go find it in the gallery. Camera File adds an option to the attach menu to take a picture. Just started playing around with this one. 

5.AAA Roadside App: I'm a road warrior, so this app to me is a no brainer if you are a member of AAA . Helps you avoid phone calls to confirm help. Using the location of your Android device a roadside assistance request is a few simple steps away. Select the type of breakdown and AAA claims that your information is delivered to a local roadside problem-solving technician for quick response. Free. I have not had to use it .. yet! 

Monday, January 24, 2011

Android Apps of the Week for Lawyers 1/24/11

Image representing Android as depicted in Crun...Image via CrunchBaseThis week it's a mix of apps for the Android phones. I'm as fun loving as the next middle aged trial lawyer, but you won't be finding me posting reviews on android apps for Twitter, FB, other social network sites, and games. You can find those on your own, or get your teenaged kid or 20 something receptionist to do that for you.

1. QuickOffice

Quickoffice is the MS productivity appe for Android devices that enables a user view and edit Word, Excel & PowerPoint files and have integrated access to multiple remote storage providers. Just like the PC version, except tiny.

2.Federal Rules:  It's $1.99, and you get:  Evidence, -FCP with amendments eff. 12/1/09 and of course the
the U.S. Constitution. I have only used it a couple of times. Worth the $2? You decide.

3.FedEx Mobile:
You can use FedEx Mobile solutions to:

  • Find a nearby FedEx location using your smart phone’s GPS 
  • Get an account-specific rate quote.
  • Access your FedEx Ship Manager® Address Book and shipping history.
  • Create a shipping label and electronically send a PDF version of it to a selected email address.

4.Line 2 for Android:From the site:

Customers can use Line2 to add a second line to their smartphone or turn an iPod, iPad or tablet device into a fully-featured telephone.

The app allows customers to make phone calls and send texts where they don’t have cell reception, reduce their cell bills, add a second line for business use, or get another number so they can keep their personal cell number private. Customers may also port in their number to Line2 for free.

Line2 for Android includes all of the functionality and features that are currently available to Apple iOS users plus few Android-only features, such as the ability to speak their text messages and have them transcribed so they can text without typing.

I'm a fan of Line 2. Why? It allows me to have another cell number to give to potential clients, current clients, and attorneys without giving up my personal cell.

If you have an app for the Android you think we should add to our list, email me at: galawyerblog(a)

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Monday's Product Headlines - FDA

European Medicines AgencyImage via WikipediaHere's a quick summary of products in the news this morning, 11/24/11:

The European Medicines Agency (EMA) issued a release saying that it would review the safety of heart drug Multaq after two cases of liver failure in patients on the drug. Link here. 

The FDA says that HCG weight loss products are fraudulent. Link here.

FDA considers more stringent rules on defibrillators. Link here

Dialysis Set recalled recently gets a Class 1 recall designation: Link
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Thursday, January 20, 2011

Texas Drug Company Shut Down by FDA

FdaImage via WikipediaA USDCT judge  has ordered a Texas drug manufacturer called Deltex to shut down its operation after a federal agency found "a history of significant violations" of federal law by the company.


After an inspection in 2008, the director of the FDA's Dallas District claimed that the company's violations involving  the methods used in, or the facilities or controls used for, their manufacture, processing, packing or holding material. 

The FDA found problems with quality control procedures as welt as  laboratory testing process. In its letter to the company the FDA wrote:
This inspection also revealed your firm is marketing unapproved drugs in violation of Section 505(a) of the Act [21 U.S.C. 355(a)] and the drugs are also misbranded in violation of Section 502(f)(1) [21 U.S.C. 352(f)(1)] and Section 502(c) [21 U.S.C. 352(c)].

The violations observed during our inspection and listed on the FDA-483 include, but are not limited to, the following:

1. Failure to follow written procedures applicable to the quality control unit and to establish adequate procedures in writing as required by 21 CFR § 211.22(d). Specifically, your SOP # QC-016-0 requires that the Quality Control Manager or designee calibrate the [(b)(4)] FT-IR spectrometer with an internal reference standard on a [(b)(4)] basis. This was not done for six months following the last calibration on November 9, 2007. In addition, your SOP # QC-012-1, requiring the Quality Control Manager to ensure that in-house calibration of all scales and balances is performed [(b)(4)] with [(b)(4)] standard weights, was not followed. Calibrations of the [(b)(4)] Scale used to weigh active ingredients were performed with only [(b)(4)] weights for a period of 11 months (February 2007 to January 2008). Also, your SOP QC-01 0-1 "Procedure for out of spec Inspection" is inadequate in that it lacks a defined protocol for the number of retests allowed, and has no requirement for expansion of an OOS investigation to manufacturing processes and procedures or any provision for expansion on an investigation to other lots potentially impacted. We acknowledge your correspondence of September 2, 2008, in response to the FDA-483 in which you outline corrective action on the calibrations of the spectrometer and balance. The response is incomplete because it does not include the promised revised SOP addressing the deficiencies in your written procedures for handling OOS test results. Additionally, the response fails to provide any documentation of the corrective actions related to the balance and spectrometer.

2. Failure to establish laboratory controls, including determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components used in the manufacture, processing, packing, or holding of drug products as required by 21 CFR § 211.160(b)(1). Specifically, during review of laboratory documentation obtained as part of your supplier's qualification program for Phenylephrine Tannate lot no. R0510; Pyrilamine Tannate lot no. R0233; and Dextromethorphan Tannate lot no. R0250, a recurrent failure to identify each peak (or absorption band) of spectra obtained using USP <197K> FT-IR identity test for functional groups characteristic of Dextromethorphan Base, Pyrilamine Base and Phenylephrine Base, was noted.
Review of the USP <197K> FT-IR Identity test spectra obtained for the stated APIs revealed that all of the spectra generated for each API had comparable peaks in all areas of the [(b)(4)] spectrum when processing the sample tested as described in USP <197K>. The established USP <197K> Identity test method lacks the capability to detect physico-chemical changes of incoming API raw materials or distinguish one of the above referenced APIs from another. Therefore, your firm's Identity test method is considered an inadequate analysis for the identification and quantitation of in-coming tannate containing APIs (i.e., Dextromethorphan Tannate, Pyrilamine Tannate, and Phenylephrine Tannate). In addition, your firm fails to document that your identity testing procedures can detect extraneous materials in lots of incoming API's salt/base forms, that may necessitate rejection of the lot. We acknowledge the corrective actions outlined in your September 2, 2008, response. However this response lacks scientific evidence designed to demonstrate that the proposed HPLC identity test is an improvement over the USP <197> FT-IR identity testing and that it is suitable for the specific identification of tannate containing APIs. Please be aware that identity testing in the context of multiple drug components that are compounds of closely related molecular structure must be able to discriminate between the compounds. There is no assurance that the proposed use of HPLC RRT as the preferred identity test method can adequately confirm the identity of incoming lots of tannate APIs.

3. Failure to establish adequate laboratory controls, including the establishment of scientifically sound and appropriate specifications designed to assure conformance with appropriate standards of identity, strength, quality, and purity as required by 21 CFR § 211.160(b). Specifically, your firm has not established specifications for: the amount of free Tannic Acid in drug products containing tannate compounds; the assay for [(b)(4)] in bulk [(b)(4)] USP (ANDA [(b)(4)] and Benzalkonium Chloride 50% in [(b)(4)] drug product. In addition, your firm has failed to establish specifications or testing procedures for dissolution or rate of drug release for drug products containing tannates. We acknowledge your September 2, 2008 response in which you state that manufacturing of all drug products containing "tannate" compounds will cease as of September 2, 2008. However, we disagree with your assertion that there are no methods by which to determine the dissolution or drug release in "tannate" preparations. Methods for dissolution and drug release testing for other oral suspension products with approved New Drug Applications (NDAs), or Abbreviated New Drug Applications (ANDAs), that have an insoluble active pharmaceutical ingredient have been developed.

4. Failure to conduct appropriate laboratory testing, as necessary, of each batch of product required to be free of objectionable microorganisms, as is required by 21 CFR § 211.165(b). For example, your firm does not conduct any preparatory testing on drug products to assess their possible inhibitory effects on microbial growth prior to testing for the presence of microorganisms. In addition, there is no growth promotion testing on the batches of media used. We acknowledge the pledge in your September 2, 2008, response to conduct preparatory testing on most product formulations by October 31, 2008. However this response is unsatisfactory because it includes no commitment to conduct growth promotion testing on each batch of growth media used. Because of the possible impact of exposure to adverse conditions while in shipment, reliance on a suppliers' Certificate of Analysis (COA) alone is not sufficient to provide a necessary degree of assurance that the purchased media will perform adequately. The performance of each lot of growth media used should, at a minimum, be confirmed upon receipt or before the first use.

5. Failure to establish and follow appropriate written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile, as required by 21 CFR § 211.113(a). For example, your firm failed to perform antimicrobial effectiveness testing on all your finished product formulations. Your response of September 2, 2008, is unsatisfactory. The determination of [(b)(4)] alone is insufficient to show the antimicrobial/preservative characteristics of a particular drug product formulation. The effectiveness of a particular solvent system, by itself or in combination with other chemical preservatives, in controlling microbial growth should be verified by actual testing.
Find the letter here.

The FDA personnel also warned the company that is had manufactured drugs that were not made in an approved method - products that include Tannate Pediatric Suspension, DuohistTM DH Liquid, Ed-A-Hist DM and Bromphenex DM.

The action by the Court?  A permanent injunction, handed down by the U.S. District Court for the Southern District of Texas to Deltex’s president, Kabir Ahmed, and vice president, Mohidur R. Khan.
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Looking at the Legal Costs in Avandia v. Vioxx

RofecoxibImage via WikipediaInteresting read which should lead as a discussion point for some lawyers. In a recent post, the author commented on the legal bills related to each drug. GSK has spent $6 Billion to defend cases involving Avandia while Merck spent $4 Billion to settle all of Vioxx.

Read it here: Link. 
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Tuesday, January 18, 2011

Florida Law: Bad Lawyering Gets a Sanction

In the law profession, you see some examples of excellence, advocacy, and ethics. The lawyer who is the subject of the opinion seems to be missing the first two.

This recent opinion is not an example of good lawyering. In fact, it makes you wonder if some who graduate from law school and pass the bar have what it takes to work as lawyers. My conclusion - retire. Find another profession.

In Marion v. Orlando Pain and Rehab, the lawsuit was dismissed because of defects in the pleadings. The lawyer appealed to the Florida 5th DCA. The lower court dismissal was affirmed per curiam by the appellate court. Apparently not satisfied by the affirmance, the lawyer on the losing end then filed a Motion for Rehearing.

The work of the lawyer may be seen from the beginning of the papers filed. I suspect that Oliver W. Holmes  - if still alive - would be cringing, because here is what the rehearing papers set forth:


2.  Please forgive in advance if, through the words of this Motion you can hear the author screaming, but I  cannot overcome my indignation engendered by this Honorable Court's per curiam affirmance of the lower court's order.  I understand that Motions for Rehearing are seldom granted by appellate courts, and for good reason.  However, I must believe that if I correctly state the facts of this case, the court will retract its opinion and reconsider the issue.  I assume that I failed in my obligation in the initial briefs.

He then went on to state that the appellees "were proven con artists." Counsel then went on to write - "now the Court seems to be saying OK" to such actions. He then wrote that he was "screaming again."

There is  a lesson here. If your case is so weak it gets dismissed, and the appellate court affirms it per curiam, let it go.  Filing a Motion for Rehearing? Do something novel - research. Or else get spanked in a public legal opinion that will live forever

To the surprise of no one, the Court said this type of conduct would be sanctioned. Read it here:

FDA Warnings for Soda?

Soft drinks on shelves in a Woolworths superma...Image via WikipediaA group of health scientists, government agencies and consumer advocates have sent correspondence to the  commissioner of the FDA, seeking that entity to require warning labels on cans and bottles of drinks containing sugar.

If you are like me, your first question is ... why?  Well,  the folks asked that the FDA consider requiring sugary drinks carry labels warning of the connection between soda and weight gain, obesity, diabetes and other health problems.

From the letter: “In light of the overwhelming evidence linking soft drinks to serious diseases, consumers deserve to know -- and soft drink labels should disclose -- those health risks,” they wrote.

I know what you are thinking - this is ... stupid. Common sense should reign supreme. The FDA, a grossly unfunded government agency that is also understaffed, has more important things to tackle. These well meaning groups need to focus on other issues.    

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Glaxo's Legal Bills for Avandia: $3.5 Billion and counting

AvandiaImage by neofedex via FlickrThere is news that Glaxo  will have fourth-quarter legal costs of $3.5 billion because of investigations into sales practices for certain products and product-liability cases related to Avandia, a diabetes drug.

The company will be putting aside additional monies for other investigations, including one by the U.S. attorney in Colorado into the company’s sales and promotional practices of certain products.

The troubles mount for Glaxo, and this report simply shows the costs related to a drug that the FDA has put under the microscope. As recently as 9/23/10, the FDA placed restrictions on the drug.

From the FDA release:

The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.” Link.

More news here.

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Monday, January 17, 2011

Another FDA Warning - Multaq - Risk of Liver Injury

Schematic diagram showing basic structure of H...Image via WikipediaNot a good week for your liver:

From the FDA -

ISSUE: FDA notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq). Information about the potential risk of liver injury from dronedarone is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.

BACKGROUND: Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm during the past six months. Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death.

RECOMMENDATION: Healthcare professionals were reminded to advise patients to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching) while taking dronedarone. Healthcare professionals should consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment. Additional information for Healthcare Professionals, for Patients and a Data Summary is provided in the Drug Safety Communication.

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FDA limits Acetaminophen in Rx Combo Products; Requires Liver Toxicity Warnings

From the FDA:

The FDA has asked  manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen, also called APAP, is a drug that relieves pain and fever and can be found in both prescription and over-the-counter (OTC) products. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). OTC acetaminophen products are not affected by today's action.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication. Patients and health care professionals are being notified of the new limitation on acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.

“There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” said Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”

Acetaminophen is also widely used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients. The actions FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.

Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency’s strongest warning for prescription drugs, be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.

An FDA advisory committee discussed the issue at a meeting in June, 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.

Link here

What is liver toxicity? From Wiki:

Acetaminophen (paracetamol, also known by the brand name Tylenol and Panadol) is usually well tolerated in prescribed dose but overdose is the most common cause of drug induced liver disease and acute liver failure worldwide.[10] Reports of death from acute hepatotoxicity have been reported to be as low as 2.5 grams over a 24 hour period[citation needed]. Damage to the liver is not due to the drug itself but to a toxic metabolite (N-acetyl-p-benzoquinone imine NAPQI, or NABQI) which is produced by cytochrome P450 enzymes in the liver.[26] In normal circumstances this metabolite is detoxified by conjugating with glutathione in phase 2 reaction. In overdose large amount of NAPQI is generated which overwhelm the detoxification process and lead to damage to liver cells. Nitric oxide also plays role in inducing toxicity.[27] The risk of liver injury is influenced by several factors including the dose ingested, concurrent alcohol or other drug intake, interval between ingestion and antidote etc. The dose toxic to liver is quite variable and is lower in chronic alcoholics.[citation needed] Measurement of blood level is important in assessing prognosis, higher levels predicting worse prognosis. Administration of Acetylcysteine, a precursor of glutathione, can limit the severity of the liver damage by capturing the toxic NAPQI.

Wednesday, January 12, 2011

Guidant Case: Judge to Decide Criminal Plea

:Original raster version: :Image:Food and Drug...Image via WikipediaIn an agreement reached with the U.S. Department of Justice last year, Guidant (now part of Boston Scientific Corp.) pleaded guilty to two federal criminal charges related to the recall, including making false statements to the Food and Drug Administration (FDA) about the devices' safety.

The company, which employs about 5,000 Minnesotans, also agreed to pay a $296 million fine. It would have been the largest criminal penalty ever levied in medical technology for violating federal laws.

Source and  more here:
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Tuesday, January 11, 2011

Android: Apps of the Week Debuts

Image representing Android as depicted in Crun...Image via CrunchBaseI switched over from an iPhone to a Google/Android phone - an HTC - and I am never going back. For lawyers, though, it seemed like the listing and description of law worthy Android apps is allover the place. Guys like iPhoneJD are great sources for iPhone ... can't find his peer.

Why the switch? Annoying things like ... no flash. No camera on my old Phone. No video. The Droid phone has them all, as well as a keyboard both on the screen and as a slide out. It also tethers quickly for a mini hot spot. For the near future, I simply don't see iPhone permitting a Flash player, or having a keyboard.  

So here is the first of a set of posts in 2011 that wll educate me and maybe you about tools you can use.

Here's what I added the first day I had my phone in hand:

1.PWN Document Scanner:  This document scanner lets you to scan documents with your phone camera, convert them into PDF, and email the PDF document to anyone or yourself.

You can choose to email the file immediately, or save it on your phone for later use. The PDF file is saved to your phone's SD card. You can scan medical reports,  receipts, you name it. I consider it my portable copier.

2.Multi Reader: MultiReader speaks your text, PDF, Word, RTF, PPT, eBook documents. That's the description. If you need more information, throw away your phone. 

3.The Now and Then Date Calculator: A decent date calculator. Read more here:

4.Dropbox: You may be familiar with this in the cloud storage system. It's on Android as well, link here. 
In a word, indispensable. 

5.Free Wi-Fi Finder: Not bad, and given the price, I like it  a lot. I was able to grab the wifi at the courthouse with it. Link.


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Albuterol Sulfate Inhalation Solution Information

A report released by the FDA announced the recall of mislabeled vials of Albuterol Sulfate Inhalation Solution.  The single-use, 2.5 mg/3 mL vials, produced by the Ritedose Corporation, “are embossed with the wrong concentration of 0.5 mg/3 mL and therefore, represents [sic] a potential significant health hazard,” says the FDA.

Though the foil overwrap pouches and shelf cartons display the correct concentration of the drug, the vials themselves bear incorrect labels which may lead doctors to mistakenly administer “5 times the recommended dose,” the report warns.  Because the outer layers of packaging are often removed when the vials are stocked in a hospital, the FDA claims it is likely that dosing errors could occur in this setting.


Studay asserts that statins may raise stroke risk in some

People who have had a type of stroke caused by bleeding in the brain should avoid taking cholesterol-lowering drugs known as statins, according to some researchers.
Although statins are commonly used to prevent heart attacks and strokes, they said the drugs could increase the risks of a second stroke in these patients, outweighing any other heart benefits from the drugs it is claimed.

The study information may be found here:

From the study: "The mechanism by which statins might amplify the risk of hemorrhagic stroke remains unclear. Historically, concerns about increased ICH risk with lipid-lowering drug therapy have centered on epidemiological studies linking low cholesterol levels with an increased rate of hemorrhagic stroke.  "

Snow and Ice Days in Georgia

2005 29 Jan - Atlanta Ice Storm - North Ave Br...Snow and ice - truck wrecks, 18 wheelers stranded, and schools closed. Folks in other parts of the country may wonder what n the world is going on in the South. 

Well, for here it's bad. 8" of snow in some parts of Atlanta. What is far, far worse is that after the snow fell, there was freezing rain which created a sheet of 1/8 inch ice on top of the snow. 

So folks  for now are staying home and working remotely. Stay tuned for updates and reports as 2011 gets off to a rough start for those in the south.

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Thursday, January 06, 2011

Avastin: Link to Heart Failure in Breast Cancer Patients?

From Yahoo and NewsDay:

A new study has been released that provides some evidence that the anti-cancer medication ups the odds of congestive heart failure in these patients.
The meta-analysis, published online Jan. 4 in the Journal of Clinical Oncology, included almost 4,000 patients and found a small but significant number developed heart failure.
ast month, the U.S. Food and Drug Administration announced plans to revoke approval of bevacizumab (Avastin) for treating breast cancer, although not for other indications. The move was based on evidence that the drug doesn't prolong overall survival in breast cancer patients and poses a risk of serious side effects.

Read more here. 

Wednesday, January 05, 2011

Chantix Lawsuits: No trials until 2012

A federal judge in Birmingham, Alabama has been assigned to more than 1,200 lawsuits involving  Pfizer Inc. and Chantix, many of them with smokers and their families claiming the drug left them with a variety of psychological problems, including anxiety, aggressiveness and suicidal thoughts.
Pfizer has more the 5 million documents on the testing and marketing of the drug that have to be reviewed. He said attorneys will have to take depositions from numerous Pfizer employees, mostly at the company's headquarters in New York City.
To read more, go here:  Link

Tuesday, January 04, 2011

More News on Fruta Planta Recall (1/4/11)

From the FDA website:

Fast Facts
  • PRock Marketing LLC, of Kissimmee, Fla., is recalling all lots of Fruta Planta and Reduce Weight Fruta Planta. This is a single product marketed under two brand names. 
  • FDA testing confirmed that Fruta Planta contains sibutramine, a drug withdrawn from the market in December 2010 for safety reasons.
  • The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death. 
  • Consumers should stop using this product immediately and throw it away in a sealed container where children and animals cannot gain access to it. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 
What is the Problem?
PRock Marketing LLC, is voluntarily recalling all lots of Fruta Planta and Reduce Weight Fruta Planta because FDA testing determined that the product contains sibutramine. Sibutramine is a drug that was withdrawn from the market in December 2010 for safety reasons. The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death.
Sibutramine was used in combination with a reduced calorie diet and exercise to help people who are overweight lose weight and maintain their weight loss. Sibutramine is in a class of medications called appetite suppressants. It works by acting on appetite control centers in the brain to decrease appetite
What are the Symptoms of Illness/Injury?
Fruta Planta and Reduce Weight Fruta Planta poses a threat to consumers because sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.  Sibutramine may also interact in life-threatening ways with other medications a consumer may be taking.
What Do Consumers Need To Do? 
Consumers should stop using this product immediately. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. PRock Marketing’s recall notice recommends that consumers throw the product away in a sealed container where children and animals cannot gain access to it or return it to the company. Consumers may reach the company at 877-225-1009 Monday through Friday from 10:00 a.m. to 4:30 p.m.  
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by: Redesigned Website Debuts 1/5/11

Skyline of Downtown AtlantaImage by Kay Gaensler via FlickrTake a peek at our newly redesigned website, found it here:

Still tweaking some items on it, making corrections and such. We're using a template over a Wordpress fouondation, which - we hope - will make mobile viewing much easier.

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Monday, January 03, 2011

Fruta Planta Recall News: Legal News

The FDA has informed consumers not to use a weight-loss product called Fruta Planta because it has been associated with several heart attacks and one death.

The maker of the product, Kissimmee, Florida -based PRock Marketing, is recalling all lots of Fruta Planta and another product called Reduce Weight Fruta Planta. It is the same product, marketed under two different names.

FDA testing of the product found that the weight-loss product contains sibutramine, a drug that was pulled from the market in December for safety reasons. Sibutramine is known to increase blood pressure and pulse rate in some patients and may present a serious risk for those with a history of coronary artery disease,congestive heart failurearrhythmias or stroke. Sibutramine also may interact in life-threatening ways with other medications a patient may be taking.

The FDA has received multiple reports of adverse events associated with the use of Fruta Planta.

Consumers should stop using the product immediately and throw it away in a sealed container so that animals and children cannot gain access to it. Consumers may reach the company at 877-225-1009 Monday through Friday from 10 a.m. to 4:30 p.m.

Call us at 404-451-7781

A New Year = Resolutions

I'm on of 'those guys'  who makes resolutions each and every year. Some may not, which is fine, but I do. Here is my list for 2011; I try to make them 'monthly' so that it's easier to hit a goal.

1.Using the cloud: 18 months ago no one knew that the cloud was, much less how to use it. Today our firm has as a backup our servers (about 50%) on a secure cloud site. The goal is to be in the cloud 100% by year end. I will tell you it helped me already - sitting at a seminar in December, I needed a document after hours, and accessing via our cloud service was a simple task.

2.Mobile: Mobile for us is use of smart phone, and use of iPad(s). I'm eagerly awaiting the CES in Vegas to see what companies have in store for tablet computers like the iPad. What will get me to switch? Any tablet that comes with 1)a USB port 2)a camera 3)video and 4)Flash player. Right now I will tell you that
this product has my attention: Toshiba tablet

I'm also a fan of the HTC smartphone from the folks at Google. Used it for more than a month, and folks at Apple better worry about me - b/c I don't miss the iPhone one bit.

3.Email only updates to clients: In the last case I resolved, our office had more than $200 in postage alone, in a garden variety case without complex issues. Most of those postage charges were to a client who had email. With postage increasing, we are looking at using email for our clients almost exclusively, and using the cloud for those who wish to see updates and pleadings. We used certified mail receipts for email, of course.
Nearly 95% of our clients have email, but interestingly enough, before we are hired, less than 50% will willingly provide it to us.   

 4. Video chat and conferencing: With more than one office, we plan to be more active in the use of video conferencing as a money saver. The tech is there now, it's less jumpy, and it just makes sense.

5.  Community Service: I know what you are thinking - this is a resolution for a law office? Yes,  this year it is. Our firm has bought in to a firm wide effort, including our Coats4Kids philanthropy. Too often the goal is to get work done, but especially in this economy good deeds can be done in small doses, and each one helps.

If you have a resolution, or would like me to put your guest post regarding what you resolve to do this year, email me at galawyerblog(at)yahoo(dot)com.