Product News and Recalls

Woman dies after switching to Pradaxa

An article in the spring issue of “The Safety Report” gives an account of a woman who died of gastrointestinal hemorrhage after switching to the anti-coagulant Pradaxa.

According to the account, she’d been taking anti-coagulant Coumadin for years because of a heart rhythm problem known as atrial fibrillation. Pradaxa was marketed as a therapeutic simplification that, unlike Coumadin, doesn’t require patients to get monthly blood tests.

Boehringer Ingelheim, the manufacturers of ...

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Zoloft litigation consolidated in Eastern District of Pennsylvania

A judicial panel has ruled that litigation by multiple parties against Pfizer, Inc., over birth defects allegedly caused by the antidepressant Zoloft, will be transferred to and consolidated in the federal court for the Eastern District of Pennsylvania.

The proceedings will consolidate 57 different actions filed in six federal court districts around the country. In the transfer order released on April 17, members of the judicial ...

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Study says infection a risk factor in blood clots

Researchers at the University of Michigan Health System are publishing a study this month in the Journal of Circulation indicating that older adults who get infections are nearly three times as likely to be hospitalized for a blood clot in their deep veins or lungs.

The study shows that recent exposure to an infection of any kind — including urinary, skin, or respiratory tract infections – is the most common ...

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Op-ed says more accountability needed for drug approvals

A recent opinion piece in the New York Times calls for more public access to the clinical data that government agencies such as the U.S. Food and Drug Administration use for making policy about medications.

Authors Peter Doshi and Tom Jefferson write that drug or medical device manufacturers are required only to share their data with regulators, who treat the data as secret, and not with independent researchers or academics.

That ...

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Bayer expecting more lawsuits over Yasmin

Officials with pharmaceutical giant Bayer said in a U.S. Securities and Exchange Commission filing that they expect more lawsuits over the company’s Yasmin line of birth control pills, Bloomberg reports. More than 11,000 lawsuits have already been filed over injuries allegedly caused by the drugs.

Last week, the company announced a settlement for about 500 lawsuits related to the contraceptives, which were the first batch of suits scheduled to go ...

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Jury says Johnson & Johnson improperly marketed Risperdal

A jury in Arkansas ruled that Johnson & Johnson officials used deceptive tactics to market antipsychotic drug Risperdal, misleading doctors about the drug’s risks and improperly marketing it for unapproved uses, Bloomberg reports.

The decision in Arkansas marks the third such jury verdict against Johnson & Johnson over allegations that the pharmaceutical giant concealed Risperdal’s risks and tricked Medicaid regulators into paying more than they should have for the medication.

Juries also decided against the company in Louisiana and South Carolina.

A total ...

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