FDA lists drugs under review for safety issues

By Susan Heavey

WASHINGTON (Reuters) - U.S. health regulators said on Wednesday they were reviewing dozens of products for potential safety problems, including some popular antidepressants, a widely used schizophrenia therapy and a well-known weight-loss drug.

The drug list was released on the U.S. Food and Drug Administration''s website as part of the agency''s ongoing review of potential drug side effects and complications, and is supposed to be updated every three months.

Among the products under review included schizophrenia drug Abilify, one of Bristol Myers Squibb Co''s fastest-growing products. Post-marketing data raised concern about possible liver toxicity and other issues, the FDA said.

The FDA also said it was reviewing Roche Holding AG''s diet drug Xenical for the risk of rectal bleeding to see whether any agency action was needed.

"The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk," the FDA said, referring to its overall list of concerns.

"It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk," it added.

Other drugs under FDA review include:

* SSRI and SNRI antidepressants for the risk birth defects

* Novartis AG''s nail fungus treatment Lamisil and Roche''s malaria drug Lariam for the risk of psychiatric events

* Novartis'' drug blood pressure treatment Diovan for possible hemolytic anemia, a type of red blood cell deficiency

* Teva Pharmaceutical Industries Ltd''s Plan B contraceptive pill for loss of consciousness. The FDA said there is no action necessary at this time on Plan B.

(Additional reporting by Lisa Richwine in Washington and Ransdell Pierson in New York)

(Reporting by Susan Heavey; editing by Richard Chang)

(Reuters Messaging: susan.heavey.reuters.com@reuters.net, Phone: 202-354-5848)