US FDA lists drugs under safety probes 09/05 01:13 PM
WASHINGTON, Sept 5 (Reuters) - U.S. health officials said on Friday they are probing safety concerns with Eli Lilly and Co's (LLY:$45.42,00$-0.67,00-1.45%) antidepressant Cymbalta, Biogen Idec (BIIB:$48.33,00$0.17,000.35%) and Elan Corp's (ELN:$12.89,00$0.11,000.86%) multiple sclerosis drug Tysabri and more than a dozen other medicines.
The drugs were included on a new quarterly list of medicines undergoing safety probes following reports from the public of health problems.
Appearing on the list does not mean the Food and Drug Administration has concluded that the drug caused the problem, the agency said. The aim is to give the public more information about potential concerns.
"We're telling the public really at the earliest stage what it is we're working on," said Dr. Gerald Dal Pan, director of the FDA office that monitors the safety of drugs after they reach the market.
The issues were identified based on reports received from January through March 2008, the agency said. Some of the problems have been previously publicly identified.
The FDA said it is evaluating reports of urinary retention with Cymbalta and skin melanoma with Tysabri, according to the list posted at fda.gov.
Two cases of melanoma were reported in Tysabri patients in February in the New England Journal of Medicine, Biogen spokeswoman Shannon Altimari said.
"We don't believe there is an increase in melanoma with Tysabri," she said.
GlaxoSmithKline Plc's (GSK:$44.98,00$-0.16,00-0.35%) cancer drug Tykerb also is being investigated after reports of liver toxicity, the FDA said. Company spokeswoman Sarah Alspach said a strong "black box" warning about the issue was added to Tykerb's prescribing instructions in July.
Officials at Lilly could not immediately be reached for comment. (Reporting by Susan Heavey, Lisa Richwine and Toni Clarke; editing by Tim Dobbyn) |
