Product News and Recalls

Formulation with controversial compound approved

The federal Food and Drug Administration has approved a new, lower-dose formulation of a Bayer corporation drug used to treat menopausal symptoms.

The drug Angeliq contains drospirenone, a synthetic progestogen that may elevate the levels of potassium in the body.

“We are pleased by the approval of this important new lower-dose option for menopausal women,” Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. “The availability of the new lower dose of Angeliq supports current guidelines which recommend ...

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Journalist: Women should be aware of Yaz/Beyaz risks

A recent piece in the magazine “Ms.” by journalist Holly Grigg-Spall urges more women to educate themselves about potential health risks concerning the birth control pills Yaz and Beyaz, manufactured by German corporation Bayer.

Ms. Grigg-Spall points out that Yaz became the most popular birth control pill in the U.S. soon after its release in 2006, as the result of a marketing campaign that the federal Food and Drug Administration subsequently ruled to be misleading. The FDA requested that Bayer run ...

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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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