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Author Topic: FDA posts list of drugs that may be unsafe - not a recall list  (Read 154 times)
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3catkidneyfailure
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« on: September 05, 2008, 08:48:21 PM »

FDA is posting this list of drugs with issues that perhaps if you are taking you would want to contact your
doctor about. This is not a recall list. This listing comes out of the new Food and Drug Cosmetic Act of 2007,
Public Law 110-85, signed in September 2007 and comes from the Adverse Event Reporting System:

http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January - March 2008 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. 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. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

http://www.guardian.co.uk:80/business/feedarticle/7777649
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.

While it looks like some of the companies making these drugs are going to be adversely impacted, ultimately it may be a good thing if the
manufacturers learn that positive and negative drug testing results should be presented to the FDA and the public, which I believe many manufacturers are not presently doing. Perhaps the negative financial impact to the drug companies could be avoided, too, in the future.
« Last Edit: September 05, 2008, 09:23:34 PM by 3catkidneyfailure » Logged
3catkidneyfailure
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« Reply #1 on: September 08, 2008, 08:45:40 PM »

http://www.fool.com:80/investing/general/2008/09/08/the-coming-great-pharma-panic.aspx
The Coming Big Pharma Panic
... Therein lies the danger. The FDA's providing only a listing of the drug and the potential problem -- no numbers on how many reports, no indication of sources (patients? companies?), no statement of what action it's currently taking with the report. Without such context, the agency runs the risk of alarming patients.

Even the agency recognizes this danger, because it states that simply because a drug is on the list "does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk."

The FDA cautions patients not to stop taking the drugs, and doctors not to stop prescribing them. However, patients could become overly concerned about health risks, and doctors could be worried about potential malpractice suits. After all, would you really want to take a drug -- for example, Suprane by Baxter (NYSE: BAX) -- when it's listed alongside "cardiac arrest"? Too little information is dangerous.

For investors, the sudden appearance of drugs on this list, especially with no prior public information about any FDA investigation, increases the downside risk of investing in this space. While the agency gave the drugmakers a heads-up -- some company's reported only receiving that notice late Thursday -- the potential for surprise and uncertainty is high.

The list can be a positive public service announcement, but only if it includes more information to let patients, doctors, and investors make more informed decisions. ...
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