Shire received a warning letter from the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) asking the drugmaker to halt distribution of specific professional marketing materials for its end stage renal disease treatment Fosrenol (lanthanum carbonate).

Biogen Idec and Elan's multiple sclerosis (MS) treatment Tysabri may cause significant liver injury within six days of the first dose, the FDA warned healthcare professionals in a letter posted today on the FDA's website.

Australia's drug and medical device regulatory agency, the Therapeutic Goods Administration (TGA), has issued a warning concerning nail fungus treatment Lamisil (terbinafine) tablets following reports of three deaths and severe liver reactions among patients.

Noven Pharmaceuticals, which manufactures Shire's attention deficit hyperactivity disorder patch Daytrana said it received a warning letter from the FDA related to a prior on-site inspection of its manufacturing facility in Miami.

Roche has accepted the recommendation of an FDA panel to place a stronger warning on its flu treatment Tamiflu, the Associated Press reports.

The FDA slapped GlaxoSmithKline with a warning letter for a series of Dear Healthcare Practitioner letters promoting Tykerb.

The FDA on Wednesday added a black box warning to GlaxoSmithKline's (GSK) Avandia (rosiglitazone), stating the diabetes treatment was linked to a potential increase in the risk of heart attacks.

Eli Lilly is strengthening the warning label to its antipsychotic Zyprexa by adding tougher language concerning weight gain and elevated blood sugar.

Drug maker Cephalon this week issued a warning to doctors about deaths linked to its powerful painkiller Fentora, the FDA said.

Yesterdays FDA notice of black-box warnings for GlaxoSmithKlines Avandia, and drugs like it, for congestive heart failure came as a surprise to many.