Archive for August, 2009

Breast cancer ‘wonder drug’ increases risk of rare tumour by 440%

Breast cancer patients given tamoxifen are more than four times more likely to develop a more aggressive tumour than those not prescribed the drug, scientists have warned. A study of over 1,000 patients found the oestrogen blocking drug reduced the risk of the most common, easy to treat cancer recurring by 60 per cent. But the chances of a rarer type not sensitive to the female hormone appearing in the opposite breast increased by an alarming 440 per cent.

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FDA looking into liver problems with weight-loss drug Alli

Alli weight loss drug orlistatThe U.S. Food and Drug Administration is taking a closer look at the weight-loss drug orlistat, which is marketed over the counter under the name Alli by GlaxoSmithKline. Roche Laboratories markets the drug at prescription strength under the name Xenical. The FDA has received 32 reports of serious liver injury among patients taking orlistat. Six cases resulted in liver failure and 27 required hospitalization.

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FDA cracks down on ibuprofen pain relief gels

The Food and Drug Administration has issued warnings to eight companies for illegally marketing pain relief ointments containing ibuprofen. Regulators said in a statement Thursday the companies do not have federal permission to market their products, which mix the popular pain relief drug with other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug.

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Parents Doubt Gardasil’s Safety

Gardasil HPV cervical cancer vaccineMany parents are gripped by doubt about the safety of Gardasil, the 3-dose vaccine that promises to protect against cancer-causing HPV infections, following media reports this week on government data that called the vaccine’s safety into question. The government report linked Gardasil to 32 unconfirmed deaths as well as incidents of blood clots and neurological disorders. More common, non-life threatening side effects of the vaccine included fainting, nausea and headaches.

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F.D.A. Warns Johnson on Antibiotic Drug

The Food and Drug Administration warned Johnson & Johnson that it did not properly monitor two human tests of its antibiotic drug candidate ceftobiprole, which is intended to treat complicated skin infections like MRSA. The agency has twice delayed approval of ceftobiprole, citing similar problems. It said Johnson & Johnson violated the protocols of its own study.

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Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine 20mg Tablets

Barr Laboratories Inc. is recalling 100-count bottles of 20-milligram tablets of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. The tablets are recalled because they could be larger than indicated, leading to super-potent doses. This could result in adverse cardiovascular, neurological, psychiatric and gastrointestinal reactions. The recalled tablets were distributed between June 11 and June 16.

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Wyeth ghostwriters pushed hormone therapy

Ghostwriters paid by U.S. phamaceutical giant Wyeth worked on dozens of articles published in medical journals under doctors’ names, court documents indicate. Many of the ghostwritten papers backed the use of hormone replacement therapy in women.

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