Archive | FDA Drug Advisory RSS feed for this section
Government report links Avandia to heart attacks
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...FDA issues warning on Advair, Symbicort, Foradil and Serevent
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...Johnson & Johnson orders massive recall of Tylenol
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...FDA Warns Bioniche on Sotradecol Promotions
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...FDA warns against body-building products
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...Tarceva Cauases hepatic failure and hepatorenal syndrome
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...Epoetin alfa- Preliminary Safety Findings points out to Deaths
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 [...]
Continue reading...Statin drugs and risk of amyotrophic lateral sclerosis
18. November 2008
Statin drugs and amyotrophic lateral sclerosis (ALS) Audience: Neurologists, cardiologists, consumers An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as “Lou Gehrig’s Disease.” The FDA analysis, undertaken after the agency received a higher than expected number of reports of [...]
Continue reading...Tiotropium risk of stroke and reports of cardiovascular adverse outcomes
18. November 2008
Tiotropium (marketed as Spiriva HandiHaler) FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that [...]
Continue reading...Raptiva (efalizumab): Boxed Warning describes risk for life-threatening infections
18. November 2008
Raptiva (efalizumab) Audience: Dermatological healthcare professionals, patients FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a [...]
Continue reading...
20. February 2010
0 Comments