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Sunday, September 07, 2008

FDA and Drug Risks

I agree that it is a good thing the FDA is listing AERS reports so we know about problems with drugs. I'd also agree that the First Quarter's (Jan-March) report is a bit too delayed for safety, being created and posted on September 5, 2008.
Potential Signals of Serious Risks
New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008
I am taken by the number of drugs on this list that are fluoride based drugs. Fluoride is implicated in the problems with CIPRO and Levaquin, two fluroquinolone anti-biotics that cause tendon rupture and other serious side effects. Fluoride is implicated in the problems with SSRI anti-depressants as well, and the bogus cavity campaign surrounding fluoridated water.

One drug on the list, IV Dilantin (Phenytoin) shows risk for 'Purple Glove Syndrome' that results from IV administration of the drug leading to swelling, edema, discoloration and pain.

PGS is not rare and elderly patients and individuals receiving large, multiple doses are particularly at risk. This iatrogenic complication may be preventable by substituting fosphenytoin for IV phenytoin.

Now if you look up fosphenytoin - you learn that it is a phosphorus containing compound requiring 75 mg. for 50 mg of phenytoin. It also has some extremely serious side effects including liver failure, pancytopenia (reduction of all blood cells), lymphoma and severe hypertension (low blood pressure that may precipitate circulatory collapse) and the same skin reaction known as 'Purple Glove Syndrome'.

While Status Epilepticus and seizure dis-order is not a slight condition, and may be life threatening in and of itself, this raises the flag for greater drug safety.

This new alert may help but it needs to be better, more timely, and the FDA needs to get out of its bureaucratic mind set and start protecting the people it is funded to serve. How about their locking the access door to Big Pharma for starters?

And if you doubt that there is no help outside mainstream medicine for seizure disorder, email us and we will be pleased to try and educate you, so you can educate your doctor. Make sure you report ANY untoward effects of any medication to your prescriber, just don't stop taking your Rx, especially in an abrupt manner.

And, please be aware that aspartame is now in this anti-seizure medication. Aspartame initiates seizures among the more than 100 problems it creates, on record with the FDA.

Remember too that you can get needed clinical drug information at Rx List.
FDA lists drugs under safety probes
By Lisa Richwine, Fri Sep 5, 2008

U.S. health officials have disclosed safety probes into over 20 medicines by companies such as Eli Lilly and Co and Biogen Idec, 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 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 at _2008Q1.htm .


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.

Shares of Celgene Corp fell more than 3 percent after the FDA identified reports of a skin disorder known as Stevens Johnson Syndrome in patients given the company's blood cancer drug Revlimid.

Celgene spokesman Brian Gill said a warning for Stevens Johnson Syndrome is already on the label for Thalomid, a predecessor to Revlimid, that is still used and is in the same class as Revlimid.

"We believe Celgene is one of the most vigilant companies out there when it comes to making sure drugs are used as safely as possible," he said.

The FDA also said it is evaluating reports of urinary retention with Eli Lilly's antidepressant Cymbalta, and skin melanoma with Biogen and Elan Corp's multiple sclerosis drug Tysabri.

Biogen spokeswoman Shannon Altimari said two cases of melanoma were reported in Tysabri patients in February in the New England Journal of Medicine.

"We don't believe there is an increase in melanoma with Tysabri," she said.

Lilly spokesman Charlie McAtee said the company was working with the FDA on the Cymbalta review. "Any information that helps patients understand their drugs, well we're all for that," he said.

GlaxoSmithKline Plc's cancer drug Tykerb also is being investigated after reports of liver toxicity, the FDA said. A "black box" warning about the issue was added to Tykerb's prescribing instructions in July, company spokeswoman Sarah Alspach said. A black box is the strongest type of warning for prescription drugs.

(Reporting by Susan Heavey, Lisa Richwine, Toni Clarke and Debra Sherman; editing by Tim Dobbyn)
Copyright © 2008 Reuters Limited.

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