FDA lists drugs under review for safety issues

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.

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.

In addition, the agency said evaluating the risk of birth defects with widely-used SSRI and SNRI antidepressants, which already carry strong warnings about suicidal behavior.

Well-known antidepressants include Eli Lilly and Co’s Prozac, Pfizer Inc’s Zoloft, GlaxoSmithKline Plc’s Paxil and Forest Laboratories Inc’s Lexapro and Celexa.

The agency said it would later determine whether to take any kind of regulatory action toward the drugs, also known as selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors.

But it cautioned the agency had not drawn any conclusions in drawing up the list. Many of the issues noted on the list have previously been disclosed by the FDA as potential concerns.

“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.”

The agency has been under intense scrutiny over its ability to monitor potential complications, prompting Congress in 2007 to require the agency to publish its safety reviews quarterly.

Other drugs under FDA review include Novartis AG’s nail fungus treatment Lamisil and Roche’s malaria drug Lariam, both for the risk of psychiatric events.

Agency officials are also looking at Novartis’ drug blood pressure treatment, Diovan, for possible hemolytic anemia, a type of red blood cell deficiency.

They also reviewed Teva Pharmaceutical Industries Ltd’s Plan B contraceptive pill for loss of consciousness, but said no action on the drug was necessary at this time.

Representatives for various companies, including Bristol-Myers and Roche, could not be reached or had no immediate comment.

The complete list is on the FDA’s website at http://www.fda.gov/cder/aers/potential_signals/default.htm

By Susan Heavey
WASHINGTON (Reuters)