Archive for April, 2012

Bayer has paid $142 million to settle Yaz and Yasmin lawsuits

The manufacturer of the birth control pills Yaz and Yasmin announced last week that it has paid $142 million to settle lawsuits alleging that the two drugs caused blood clots and other serious injuries. Bayer Pharmaceuticals said in a report that it is settling Yasmin and Yaz lawsuits involving venous clot injuries, including pulmonary embolism, deep vein thrombosis, heart attack, stroke and other conditions caused by blood clots.

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FDA Plans ID-Tag System to Detect Faulty Devices

The Food and Drug Administration is devising a new system for detecting malfunctions in medical devices that will tap medical and billing records from hospitals and insurance companies. The system is designed to catch malfunctioning devices like the St. Jude Medical Inc. heart defibrillator wires, DePuy ASR hip repalcements and transvaginal surgical mesh. The agency wants to assign a new bar-code-like identification number to medical devices.

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Antidepressants may not be worth the risks, researchers say

Antidepressant drugs may be doing more harm than good, with their use linked to higher risks of developmental problems in infants and stroke in the elderly, according to new research from McMaster University. “We need to be much more cautious about the widespread use of these drugs,” Paul Andrews, an evolutionary biologist at the Hamilton university said.

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Maker recalls ‘X-Rock’ male supplement

The makers of an over-the-counter male sexual supplement are recalling the product after government tests showed some unlisted ingredients “pose a threat to consumers,” the company says.

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U.K. Agency Urges Ban on Metal Hip Implant Combination

Surgeons should stop using a particular combination of Johnson & Johnson and Stryker Corp. metal hip devices because of “unacceptably high” rates of follow-up operations, British regulators said. Patients with a combination of Mitch TRH cup/heads made by Finsbury Orthopaedics, a unit of J&J, and Accolade femoral stems made by Stryker, should be closely monitored, the U.K.’s Medicines and Healthcare products Regulatory Agency said in a statement on its website. After four years, 10.7 percent of patients with the product combination required a second operation, according to a patient registry. Finsbury was acquired by DePuy Orthopaedics in 2009.

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Change in the pregnancy category for topiramate

The TGA is advising health professionals of the change in the pregnancy category for topiramate-containing products from B3 to D.

Topiramate [Topamax] is indicated for the treatment of epilepsy in adults and children aged two years and over, and for the prophylaxis of migraine headache in adults. There are also reports of off-label use of topiramate to assist with weight loss. Continue reading ‘Change in the pregnancy category for topiramate’

Statins don’t reduce melanoma risk: study

Despite earlier indications that people taking statins might have a reduced risk of developing melanoma, a large new study of women finds the popular cholesterol-lowering drugs do nothing to prevent the deadly skin cancer. About 45 million Americans take statins, which include atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor) and others, to lower their cholesterol.

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