The dangers and risks of Paxil

Buyer Beware of Herbal Formulas and Vitamins?

Caveat emptor – or “buyer beware” – is a cautionary note often applied to dietary supplements. The implication is that the buyer of herbal formulas and vitamins is, more or less, on his own because these items are not regulated with the same strict FDA guidelines that require patent medicines to be thoroughly tested for efficacy and safety.

I’ll wait for everyone to stop laughing before I go on.

Last week, HSI Panelist Allan Spreen, M.D., sent me an item that puts the caveat frosting on the emptor cake.

Dr. Spreen and many other physicians recently received a friendly letter from the drug giant GlaxoSmithKline concerning a side effect of the GSK drug Paxil; a selective serotonin reuptake inhibitor (SSRI), used for treating depression, panic disorder, social anxiety and obsessive compulsive disorder. Dr. Spreen scanned his copy and sent it along in an e-mail.

GSK researchers conducted a new meta-analysis of several placebo-controlled clinical trials and wanted to share these the findings with doctors. In a nutshell, the letter warns that Paxil use may be associated with increased risk of suicide and suicidal thoughts in patients under the age of 30. This is an “official” confirmation of evidence that’s been circulating for years.

But if you or someone you know is taking Paxil, don’t toss that bottle of pills in the dumpster. According to the New York Times, an FDA statement issued last week included this tip: “It is essential that patients taking Paxil do not suddenly stop taking their medication.”

Why not put the breaks on Paxil? It seems that the drug has another unique little wrinkle. According to the Paxil web site, some people report the following side effects when Paxil use is abruptly discontinued: “dizziness, sensory disturbances (including electric shock sensations and tinnitus), abnormal dreams, agitation, anxiety, nausea, sweating, mood fluctuations, headache, fatigue, nervousness and sleep disturbances.”

Paxil was approved by the FDA in 1993, but it took years before the problems with discontinuation were recognized and the potential link with suicide risk was discovered. You can’t help but wonder what strange and wonderful things we’ll find out about Paxil over the next 13 years.

Sources:
“Antidepressant May Raise Suicide Risk” Benedict Carey and Gardiner Harris, New York Times, 5/12/06, nytimes.com