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Epoetin alfa- Preliminary Safety Findings points out to Deaths
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...Propafenone HCl Tablets recalled due to oversized tablets
18. November 2008
Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg Morphine Sulfate Extended Release Tablets 15 mg Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg Dextroamphetamine Sulfate Tablets 10 mg Audience: Pharmacists, other healthcare professionals, patients Ethex Corp and FDA notified healthcare professionals of a voluntary recall of [...]
Continue reading...Infants’ Mylicon Gas Relief Dye Free Drops Recalled
18. November 2008
Johnson and Johnson–Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants’ Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants’ MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic [...]
Continue reading...Benzoyl Peroxide Acne Cream 10% Contained Burkholderia Cepacia Bacteria
18. November 2008
Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication Equate: Medicated Acne Gel Audience: Consumers, dermatologists, pharmacists, other healthcare professionals CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. The [...]
Continue reading...Phosphocol P 32 and leukemia
22. September 2008
Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) [...]
Continue reading...Tysabri monotherapy and progressive multifocal leukoencephalopathy
25. August 2008
The FDA has recently received information from the manufacturer about two new cases of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri monotherapy for multiple sclerosis in Europe. Both patients had received Tysabri for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients [...]
Continue reading...Byetta and hemorrhagic or necrotizing pancreatitis
18. August 2008
FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time [...]
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18. November 2008
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