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pills2According to a recent news release, regulators in Europe have concluded that there is little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer.

In addition to the European agency, the Food and Drug Administration has been reviewing the safety of a big class of drugs that includes Januvia by Merck and the drugs Byetta, Bydureon and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca.  These drugs, called incretin mimetics by the FDA, increase the body’s levels of a hormone that helps to control blood sugar levels.

They have, however, been linked to pancretic inflammation known as pancreatitis.  While the European agency said that the clinical trials had shown no increased risk of pancreatic cancer,the FDA said the trials were too small to draw firm conclusions.

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medicationJune brought changes to forty-four (44) medical product labels (up slightly from 40 changes in May), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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pills2The Food and Drug Administration (FDA) has been considering making changes to its labeling rules with regard to generic drugs.  The changes could provide generic drug users with more protection.

Currently, those that have been injured by a brand-name drug can win compensation from the manufacturer if it can be shown that the drug was unreasonably dangerous or that the warning label did not disclose the risks properly.  Those injured by a generic medicine?  Not so much.  Those injured by a generic medicine can’t hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.  Crazy, huh?

All of that could be changed by a new rule that the FDA expects to formally propose in September.  The new rule would “revise and clarify procedures for changes to the labeling” of approved drugs.  This will include both brand names and generics.  This change would either enable or require (not yet clear based on the information provided by the FDA) drug makers to announce possible changes to their warnings while the FDA is considering the warning.

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medicationThe FDA has shut down 1,677 sites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards.  Other sites received regulatory warnings.

While the prices look good, you never really know what you’re getting.  These products can have too much or too little of the active ingredient that people need for the treatment of their disease, and some could have toxic ingredients.  Several of the sites had sleek interfaces and names that could easily be confused with legitimate pharmacies.  Walgreens-Store.com for example – the drugstore chain is actually Walgreens.com.

Though many of the sites present themselves as Canadian, most of them are based overseas – China, India, Pakistan, all around the world.  The National Association of Boards of Pharmacy recently performed an analysis of more than 10,000 websites and found that 97% did not fully comply with state and federal regulations. 88% didn’t require a valid prescription, and almost half of them sold medicines lacking FDA approval.

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painA Georgia federal jury ruled for the Defendant this week, determining that Mentor Worldwide LLC was not negligent in its design, manufacture, and sale of the ObTape pelvic mesh.

Also known as a vaginal sling, Plaintiff was implanted with the ObTape in December 2004 to treat bladder prolapse and urinary incontinence.  Six months later, she was diagnosed with vaginitis and a doctor found that the mesh had extruded into her vagina.

She filed suit claiming that the ObTape caused vaginal erosion and required surgical removal.  She further claimed that the pore size of the ObTape was insufficient to allow for tissue to become integrated into the device.  She said the mesh created a propensity for infection and/or abscess, resulting in an unreasonably high rate of infection, abscesses, tissue erosion and mesh extrusion.

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May brought changes to forty (40) medical product labels (down from 48 changes in April), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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A recall of one lot of Advance Pharmaceutical’s 81mg Enteric Coated Aspirin tables is being recalled as it may contain Acetaminophen 500mg tablets.

Affected by this recall is the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tables, 81 mg, Lot 13A026.  Packaged in bottles of 120 tables, the NDC code is 0536-3086-41, UPC code is 3 0536-3086-41 9, and the expiration date of 01-2015.

The recall was announced after a complaint of the error was reported.  Consumers may be inadvertently taking Acetaminophen instead of Aspirin, which may cause severe liver damage to those who take other drugs containing acetaminophen.

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davinciThis week, a Washington state court granted the first verdict for a slew of cases concerning the da Vinci Surgical System robots. The jury found that the robot’s creators, Intuitive Surgical, was not liable for the death of a surgery patient who succumbed to complications of a robot assisted prostatectomy. These robots, part of a $2.2 billion dollar industry, have allegedly resulted in patient injury and death. This case was the first of approximately thirty that are currently working their way through the courts with many, many more sitting on the sidelines that may settle before suit is ever filed.

The plaintiff settled for an undisclosed amount with his doctor, and then sued Intuitive Surgical. Plaintiffs alleged that Intuitive failed to properly instruct the robot’s handler, and that they also failed to inform of the potential dangers. The doctor, who had performed a hundred successful traditional prostatectomies, was only trained for a single day and performed two supervised surgeries before being cleared to work on his own.  Let’s put it this way: would you ever allow this doctor to use the da Vinci on you if you knew that?  The answer?  Of course not.

Intuitive agreed with the plaintiffs on the doctor’s negligence and claimed he never should have used the da Vinci system on the particular patient due to his obesity.

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Last month we told you that a group of Plaintiffs had filed a motion to consolidate all federal Lipitor diabetes lawsuits before one South Carolina judge as part of a Multi-District Litigation or MDL.  To date, at least five different Lipitor lawsuits have been filed against Pfizer in three different U.S. District Courts throughout the country. The motion indicates that numerous additional complaints are expected.

lipitorNot surprising, Pfizer has indicated that they are opposed to the formation of coordinated proceedings involving Lipitor, arguing that the litigation is not sufficient big enough to require the consolidated proceedings and that such a procedure would only result in a wave of lawsuits filed by lawyers who may not otherwise be willing to litigate claims.

Lipitor has been linked to diabetes. Lipitor prevents an enzyme in the liver from creating low density lipids (LDLs).  The drug works to prevent the production of LDLs, a type of cholesterol that blocks arteries, and reduce the user’s risk of developing heart disease. Lipitor, which generates more than $14.5 billion in combined annual sales, is among the best selling drugs in the world.

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Five plaintiffs last week sought an MDL for federal lawsuits against Pfizer’s Lipitor.  The allegations are the same in all cases: the cholesterol drug caused them to develop diabetes.

The gist of plaintiffs claims is that the drug increased serum glucose levels causing diabetes.  Pfizer never properly let patients or doctors know of this risk so they could make a different choice or perhaps avoid this class of drugs all together. Accordingly, the suits allege, Lipitor is defective and unreasonably dangerous and the drug was sold with a warning that did not properly alert patients and doctors of the risk.

Not for nothing, Pfizer has been making money had over fist with Pfizer.  If you have help Pfizer stock in the last few years, you have gotten pretty rich in no small part due to Lipitor.