"FDA Patient Safety News," the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors.
Read more ...
EMEA recommends the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride)
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride), from Janssen-Cilag International NV, because of a defect with the delivery system of the medicine that could lead to patients being overdosed.
Read more ...
FDA Warns Public of Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic.
Read more ...
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government has seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals.
Read more ...
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
The U.S. Food and Drug Administration has sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
Read more ...
EMEA recommends suspension of the marketing authorisation of Acomplia
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU).
Read more ...
European Medicines Agency recommends update of product information of Tysabri
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Tysabri (natalizumab) be updated to further increase awareness about the risk of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS) who have been treated with the medicine.
Read more ...