UPDATE 2-U.S. FDA lists drugs under safety probes
(Recasts first paragraph; adds additional FDA comments, details on drugs, reaction)
By Lisa Richwine
WASHINGTON, Sept 5 (Reuters) - U.S. health officials have disclosed safety probes into over 20 medicines by companies such as Eli Lilly and Co (LLY.N: Quote, Profile, Research, Stock Buzz) and Biogen Idec (BIIB.O: Quote, Profile, Research, Stock Buzz), a step required by Congress to address concerns the agency had been slow to warn of risks.
The U.S. Food and Drug Administration said on Friday that patients shouldn't overreact to the list of medicines undergoing safety probes following reports from doctors, patients and others of health problems.
Appearing on the list, agency officials said, does not mean the FDA has concluded that the drug caused the problem.
"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 agency had been criticized as slow to alert patients about serious heart risks with Merck & Co's (MRK.N: Quote, Profile, Research, Stock Buzz) withdrawn arthritis pill Vioxx and reports of suicidal behavior in children taking antidepressants.
A law enacted last year required the FDA to tell the public each quarter about new safety data.
But agency officials voiced concern the preliminary information could cause patients to stop taking important drugs. "Don't stop taking your medicine," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Drugmakers also urged patients to keep taking their medicines unless a doctor tells them otherwise.
"The FDA needs to strive for communications that include the full context of the medication's benefits and risks," said Ken Johnson, a spokesman for the industry group Pharmaceutical Research and Manufacturers of America.
The list was posted at the FDA's website here .
SAFETY ISSUES
The safety issues were identified based on reports received from January through March 2008, the FDA said.
The list does not specify how many reports have been received and some problems have been previously made public.
Officials said they hoped the list would encourage more reports of any problems. Drugs on the list may be subject to future warnings or other actions from the FDA. Continued...
Ads by Career Builder
Revenue Cycle Management/ Healthcare
Details: Growing Healthcare Consultancy organization seeks experienced Healthcare Revenue Cycle Management Consultancy talent (on...modeling, and labor productivity initiatives to healthcare providers and payers. INITIATIVES range from extensive...
Work from Home as a Healthcare Recruiter
Details: Work from Home as a Healthcare Recruiter Health Career Agents is an international healthcare recruiting and medical staffing company...Our organization represents high-demand healthcare professionals and works to secure the most desirable...
Regional Operations Director - Healthcare
Details: ...Director Regional Operations Director - Healthcare This position will be working out of...travel Good to have skills/experience: Healthcare Multi-Site Management experience What...provide exceptional benefits including the healthcare industry's most generous profit sharing...
Lawson Analyst - Payroll for healthcare
Details: ...Analyst with great experience within a healthcare industry environment, please read on...Medical Financial, Application Analyst, Healthcare Systems, Payroll, Oracle, Access...for the Lawson Analyst - Payroll for healthcare position, and have a background that...







