-Caveat Lector- ------- Forwarded message follows ------- Date sent: Tue, 22 Jan 2002 23:49:04 -0800 From: Russ Kick <[EMAIL PROTECTED]> Subject: Konformist: Paxil causes addiction, manufacturer admits (2 articles) To: [EMAIL PROTECTED] Send reply to: [EMAIL PROTECTED]
Guardian (London) 23 Jan 2002 Drug firm issues addiction warning Sarah Boseley, health editor The makers of a leading antidepressant of the Prozac class have been forced to issue a new warning to patients and doctors, acknowledging that some people get hooked and might suffer severe side effects when they try to stop taking it. GlaxoSmithKline, the British drug company which makes the best-seller Seroxat [called Paxil in the US] , was yesterday also found to be in breach of the industry's code of practice by misleading the public after one of its executives said on television that reports of withdrawal symptoms were "very rare". The new warning for Seroxat was demanded by the food and drug administration, which licenses medicines in the United States. It is a severe blow to the makers of SSRIs (selective serotonin reuptake inhibitors), which were launched in the 80s as wonder drugs which had none of the addiction problems of the benzodiazepines such as Valium and Ativan. The warning says that patients must be monitored for side effects associated with physical dependency on the drug. "A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible," it says, and if "intolerable symptoms occur" the patient might have to go back on the full dose and be weaned off more gradually. Recent trials for new uses of the drug - for instance, in cases of post-traumatic stress disorder - found that even with a gradual reduction in the dose, at least two in every 100 people suffered abnormal dreams or pains resembling electric shocks, and seven in every 100 experienced dizziness, the FDA said. It added that similar side effects had been reported for the other SSRIs, including Prozac. GlaxoSmithKline has long denied that its drug could cause dependency. .... rest of the article is at <www.guardian.co.uk/uk_news/story/0,3604,637891,00.html> ********************************************** Taken from the FDA's Website, the following is the new language that will be added to Paxil's warning label: PRECAUTIONS General Discontinuation of Treatment with Paxil: Recent clinical trials supporting the various approved indications for employed a taper phase regimen, rather than an abrupt discontinuation of treatment. The taper phase regimen used in GAD and PTSD clinical trials involved an incremental decrease in the daily dose by 10 mg/day at weekly intervals. When a daily dose of 20 mg/day was reached, patients were continued on this dose for 1 week before treatment was stopped. With this regimen in those studies,the following adverse events were reported at an incidence of 2% or greater for Paxil and were at least twice that reported for placebo: abnormal dreams (2.3% vs 0.5%), paresthesia (2.0% vs 0.4%), and dizziness (7.1% vs 1.5%). In the majority of patients, these events were mild to moderate and were self-limiting and did not require medical intervention. During Paxil marketing, there have been spontaneous reports of similar adverse events, which may have no causal relationship to the drug, upon the discontinuation of Paxil (particularly when abrupt), including the following: dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), agitation, anxiety, nausea, and sweating. These events are generally self-limiting. Similar events have been reported for other selective serotonin reuptake inhibitors. Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Paxil is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see DOSAGE and ADMINISTRATION). DOSAGE AND ADMINISTRATION Discontinuation of Treatment with Paxil: Symptoms associated with discontinuation of Paxil have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Paxil is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. http://www.fda.gov/medwatch/SAFETY/2001/dec01.htm#paxil Your use of Yahoo! Groups is subject to http://docs.yahoo.com/info/terms/ ------- End of forwarded message ------- ------------------------ "In little more than a year we have gone from enjoying peace and the most prosperous economy in our history, to a nation plunged into war, recession and fear. This is a nation being transformed before our very eyes." http://www.truthout.com Steve Wingate, Webmaster ANOMALOUS IMAGES AND UFO FILES http://www.anomalous-images.com <A HREF="http://www.ctrl.org/";>www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. Proselytizing propagandic screeds are unwelcomed. Substance�not soap-boxing�please! 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