New FDA Web Site Exposes Drug Risks to Public

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darius So.App.Mtns., United States(Zone 5b) Jun 07, 2005

I posted this in the Healthy Living forum but I know many folks don't visit that forum, so here it is again.

New FDA Web Site Exposes Drug Risks to Public

The Food and Drug Administration (FDA) may finally be taking a step in the right direction. After being publicly scrutinized by Congress, medical experts and consumers for its slow response to emerging information about cardiovascular risks prompted by pain medications, the FDA is starting to offer risk information to the public much sooner.

How? The agency has launched a new Web site, Drug Watch http://www.fda.gov/cder/, which will issue alerts to patients and doctors regarding drug safety concerns.

So far, the safety alerts posted on the site are significant, as they highlight the risks posed by doctors prescribing drugs for purposes never approved by the FDA -- an approach known as "off-label prescribing."

Making a Change

The site is certainly a notable change, considering how the FDA used to communicate drug risks: For months or years they privately weighed and debated risk information with drug companies until a final decision was made on the scientific significance of danger.

The agency will still give drug companies a heads-up before posting new, potentially damaging information about safety concerns they find. However:

* The FDA won't discuss the results with the drug companies.
* The companies won't have a chance to review it before it's posted.

But, while the FDA seems to be making a move in the right direction, one hang-up remains: The site calls on patients to find drug information on the Internet instead of it being given to them when they pick up prescriptions.

http://seattletimes.nwsource.com/html/nationworld/2002283278_drugs21.html

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