Drug Warnings outline Danger

[elisa]

Some excerpts of the article.
http://www.usatoday.com/news/health/..._x.htm?POE=cli

When the Food and Drug Administration wants to get a message across loud and clear about a prescription drug's risk, it tells the manufacturer to add a black-box warning to the label.

Several high-profile drugs in recent months have been given new black-box warnings — named for the narrow outline of a rectangle that surrounds their boldface text.

But some observers suggest that the federal agency may be relying too heavily on the label warnings and accompanying printed materials.

When pharmacists dispense these drugs, they'll hand out consumer-friendly MedGuides explaining risks and benefits.

The FDA uses such tools to ensure that the only patients who take potentially dangerous drugs are those for whom the benefits outweigh the risks. But even FDA officials acknowledge that they really don't know how effective black-box warnings and MedGuides are in maximizing safe prescribing.

You know, evaluations of the effectiveness of any of these programs are really limited," Ann Trontell, deputy director of the agency's Office of Drug Safety, told an FDA advisory panel in February.

Clearly, the track record of black-box warnings, MedGuides and "Dear Health Care Professional" letters — often sent to doctors and pharmacists when a new warning is added to a drug label — is uneven.

"There are a lot of examples that, at best, don't provide you with much reassurance that labeling changes work," Alastair Wood, a pharmacologist at Nashville's Vanderbilt University and chairman of the NSAIDs advisory panel, said at the February meeting. "That is not to say we shouldn't do them, but certainly, just labeling changes on their own have not been extraordinarily effective."

"I don't think black-box warnings are going to be any more effective than 'Dear Doctor' letters," says the study's lead author, Robert Cluxton Jr., an associate professor of pharmacy practice and family medicine at the Cincinnati pharmacy college.

Cluxton says the FDA needs to be more proactive to counter drug company marketing. "Even if the FDA would just go to the major (medical) meetings — like go to the major arthritis meetings — and do a special session," he says. "Physicians want to understand what is going on. They just don't want a very brief message: 'You should do this because we think so.' "

Physicians are only one part of the problem, Heaton and Cluxton say. "From my perspective, we need to get people other than the doctors involved in this," Cluxton says. "It's got to be the pharmacist, and it's got to be the patient."

"I don't think this will be a true test, frankly, of the benefits or lack thereof of increasing warning labels," says Levin, director of the New York-based Center for Medical Consumers. "It's hard for people to understand that something can be approved, can be advertised, can be prescribed for you by a doctor and still not be safe."

[scotty]

""Even if the FDA would just go to the major (medical) meetings — like go to the major arthritis meetings — and do a special session," he says. "Physicians want to understand what is going on. They just don't want a very brief message: 'You should do this because we think so.' "


I hereby volunteer my time to go to major medical meetings! How about you Rob??