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.

After a number of cases of serious liver damage in Australian patients taking Prexige, Novartis withdrew the drug in that country.

The FDA has announced new black box labeling for Genentechs Xolair (omalizumab) to address the risk of anaphylaxis in patients using the asthma drug.

FDA has asked GSK and Takeda to place boxed warnings of congestive heart failure risks on the labeling for their type 2 diabetes drugs, Avandia and Actos.

GlaxoSmithKline is stressing Avandia safety with doctors but has no plans for a DTC campaign to address concerns with the diabetes drug.

The FDA has sent 20 Warning Letters to companies ordering them to stop marketing unapproved products containing ergotamine tartrate, which is used to treat vascular headaches.

The FDA has stepped up efforts to combat what it sees as the No. 1 pharmaceutical marketing compliance problem, said Division of Drug Marketing, Advertising and Communication chief Thomas Abrams: ads that omit or downplay risk information.

The halt of Pfizer's torcetrapib program has potentially far-reaching implications for the broader industry and raises questions about safety of other drugs in its class, analysts said.

Merck has responded to an FDA “approvable” letter for Arcoxia (etoricoxib), an investigational selective Cox-2 inhibitor, with results of the MEDAL program.