Two new studies suggest Avandia may cause serious heart problems. FDA will reveal on Friday the data it is reviewing ahead of an advisory panel meeting about the safety of the popular diabetes drug. The meeting, scheduled for July 13 and 14, comes on the heels of two new studies suggesting that Avandia may cause serious or [...]
Continue reading...12. June 2010
According to a study published in the British medical journal The Lancet Oncology, certain blood pressure medications may be linked to increased risk of cancer. The drugs in question are called angiotensin-receptor blockers or ARBs, AT1-receptor antagonists or sartans, are a group of pharmaceuticals which modulate the renin-angiotensin-aldosterone system. Their main use is in hypertension (high blood pressure), [...]
Continue reading...27. May 2010
The Food and Drug Administration is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet. The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug. There is no [...]
Continue reading...20. February 2010
The diabetes drug Avandia produced by GlaxoSmithKline is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released on 20., February of 2010. The senate report by the Senate Finance Committee also criticized the FDA, [...]
Continue reading...18. February 2010
The Food and Drug Administration has issued warnings on Advair, Symbicort, Foradil and Serevent. The FDA said they should be used only by asthmatics who can’t control their lung disease with other medications — and then only for the shortest time possible. The FDA is taking steps to curb use of some long-acting asthma drugs taken [...]
Continue reading...17. January 2010
Johnson & Johnson issued a massive recall Friday of over-the-counter drugs including Tylenol, Motrin and St. Joseph’s aspirin because of a moldy smell that has made people sick. It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008.Federal regulators criticized the [...]
Continue reading...27. October 2009
FDA sent Bioniche Pharm a written warning notice for a series of websites promoting its varicose vein treatment Sotradecol. In the letter, the FDA said that it reviewed two Sotradecol web pages located on the Bioniche Pharma website (www.sotradecolusa.com or “Bioniche web page”) and the AngioDynamics, Inc. website (www.angiodynamics.com/pages/products/Sotradecol.asp or “AngioDynamics web page”) as part of its [...]
Continue reading...29. July 2009
The Food and Drug Administration warned the public Tuesday not to use body-building products marketed as containing steroids or steroid-like substances. The agency said many of the products are sold as dietary substances, but are actually unapproved and misbranded drugs. “Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially [...]
Continue reading...18. November 2008
Tarceva (erlotinib) – Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva Tarceva (erlotinib) Tablets Audience: Oncological healthcare professionals OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with [...]
Continue reading...18. November 2008
FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for [...]
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10. July 2010
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