Product News and Recalls

Bayer suing over controversial birth control

Bloomberg reports that a unit of Bayer is suing generic drug manufacturer Watson Pharmaceuticals Inc. over allegations that Watson has violated a patent for Beyaz birth control pills.

A spokesman for New Jersey-based Watson said the company intends to contest Bayer’s claims.

Bayer has requested that a judge ban the sale of birth control pills based on the patent.

Beyaz and other birth control pills containing the compound drospirenone has served as the basis of read more.... --> continue reading...

FDA warns of mixing statins, protease inhibitors

The federal Food and Drug Administration put out a warning on March 1 about mixing protease inhibitors, used to treat HIV and hepatitis C, and certain types of the cholesterol-lowering drugs called statins.

The combination of the drugs can cause a form of muscle injury called myopathy, according to the FDA. The most serious form of myopathy, called rabdomyolosis, can lead to deadly kidney failure.

According to the FDA, labels for both the protease inhibitors and the affected statins are being updated ...

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Journal says more women needed in medical testing

A recent opinion piece in the Journal of the American Medical Association faults the federal Food and Drug Administration for not adequately taking gender differences into account for medical device clinical trials.

Authors Sanket S. Dhruva, MD, and Rita F. Redberg, MD, MSc, note early on that women generally have higher bleeding rates and procedural death rates than men, meaning the risk/benefit assessments for implanted medical devices can be different for women.

The FDA is aware of this situation, and has put ...

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New pharmaceuticals boost profits for Bayer

German corporation Bayer will rely on commercialization of its new pharmaceutical products to bolster its profits in the year ahead.

A recent report by the corporate giant trumpets its sales in the past year, stating they rose by 4.1 percent in 2011 to $48.2 million. The report specifically mentions Bayer’s HeathCare subgroup, responsible for pharmaceutical products, as contributing to the profitability.

“One of our strengths continues to be our well-stocked development pipeline in pharmaceuticals,” Bayer CEO Dr. Marijn Dekkers said. Several times, ...

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Woman’s infertility blamed on Yaz

Indiana TV station WTHR recently ran a segment about the birth control pill Yaz, manufactured by Bayer.

The report spotlights Indianapolis-area resident Linda Rosenberg, who is no longer able to conceive children as a result of treatment she received for a blood clot in her ankle. Rosenberg suffered the blood clot after taking Yaz, which numerous studies have linked to blood clots.

WTHR report notes that 50 patients have reportedly died from taking Yaz, Yasmin, and Beyaz, and thousands of others have ...

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FDA to study misleading ads such as the 2007-2008 Yaz commercials

The federal Food and Drug Administration will study the impact of “corrective” advertising on consumers’ false perceptions of drug safety and effectiveness.

In a notice posted to the Feb. 29 Federal Register, the agency cited ads run by Bayer in 2009 at FDA’s behest to correct false or misleading claims and omissions it had made when advertising Yaz.

But the agency said: “researchers and policymakers currently lack exhaustive empirical literature regarding the various impacts of corrective (direct-to-consumer) advertisements on prescription drug consumers. ...

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