Guest guest Posted December 8, 2004 Report Share Posted December 8, 2004 SSRI-Research@ Tue, 7 Dec 2004 07:39:42 -0500 Wyeth is evil... " Efexor, which is marketed as Effexor in the United States, may cause irregular heart rhythms, withdrawal symptoms and have a higher rate of death from overdose than similar drugs, British regulators said. The anti-depressant is the Madison, N.J.-based pharmaceutical company's best-selling drug. " The United Kingdom's Medicines and Healthcare Products Regulatory Agency said there should be stronger warnings about withdrawal reactions such as anxiety and insomnia for all anti-depressant drugs. It also said there should be a warning that anti-depressants may increase the risk of suicidal thoughts and self-harm in a small group of people. " A call seeking comment from the U.S. Food and Drug Administration about the U.K. decision was not immediately returned Monday. " So finally, after all these years, we get some warning of the very serious adverse " physical " effects of one of these antidepressants. Continue to hope for the warnings on diabetes and hypoglycemia, cancer (although Effexor is one that does warn of cancer as a side effect), Cushing's Syndrome, breathing problems, bone loss, etc., etc., etc. Ann Blake Tracy, Ph.D., Executive Director, International Coalition For Drug Awareness Website: www.drugawareness.org Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio tape on safe withdrawal: " Help! I Can't Get Off My Antidepressant! " Order Number: 800-280-0730 Office: 801-282-5282 http://www.forbes.com/technology/ebusiness/feeds/ap/2004/12/06/ap1694586.html Associated Press Update 1: Regulators Suggest Restricted Use of Drug 12.06.2004, 05:29 PM British regulators recommended Monday that physicians restrict the use of the anti-depressant Efexor because its use could have side effects for heart health and pose other risks that require more careful monitoring than its competitors. The drug's manufacturer, Wyeth, said it would challenge the decision, but its shares slipped 3 percent. The United Kingdom's Medicines and Healthcare Products Regulatory Agency said there should be stronger warnings about withdrawal reactions such as anxiety and insomnia for all anti-depressant drugs. It also said there should be a warning that anti-depressants may increase the risk of suicidal thoughts and self-harm in a small group of people. The recommendations are the result of a British government study launched 18 months ago to study the safety of anti-depressant drugs known Selective Serontonin Reuptake Inhibitors, or SSRIs. Last year, as part of that study, the British government said that Prozac was the only anti-depressant suitable for people under the age of 18. The revelations about Efexor come amid growing concern about drug safety. In September, Merck & Co. withdrew its pain reliever Vioxx because it doubled patients risk of heart attacks and strokes. Efexor, which is marketed as Effexor in the United States, may cause irregular heart rhythms, withdrawal symptoms and have a higher rate of death from overdose than similar drugs, British regulators said. The anti-depressant is the Madison, N.J.-based pharmaceutical company's best-selling drug. The agency is recommending that only specialists prescribe Efexor and that patients should be continually supervised. The drug should also not be prescribed to patients with heart problems, the agency said. Wyeth said it will challenge the agency's action and urged it to accept the company's previous recommendations for labeling, educational initiatives and new packaging to reduce the risk of suicide and overdose. " We don't think there is scientific basis for what was done in the U.K., " said Dr. Joseph Camardo, Wyeth's senior vice president for medical affairs. Camardo said he expects the company appeal will be heard in January. He added that the U.S. label details a list of symptoms that patients may suffer when they stop using the drug. He also said the American label discloses the possibility that high doses of the drug can cause irregular heart beat. Camardo worries that the restrictions could hurt patients who need the drug because the wait to see a specialist in the U.K. is very long. It is too soon to say whether the actions by British regulators will hurt Efexor sales. Prudential Equity group LLC analyst Timothy Anderson wrote that the risk to Efexor isn't really in the U.K., where he expects the drug to ring up $170 million in sales this year. He's concerned other countries could also demand more restrictive labeling and that the news coverage generated by the U.K. ruling could taint consumer perception in other markets. A call seeking comment from the U.S. Food and Drug Administration about the U.K. decision was not immediately returned Monday. Also Monday, investment firm Merrill Lynch downgraded Wyeth to a neutral from buy because the stock has risen 15 percent since the middle of the year and it still faces some uncertainty over the lawsuits from two diet drugs it withdrew. Wyeth shares slipped $1.29, or 3.1 percent, to end the day at $40.27 on the New York Stock Exchange. Quote Link to comment Share on other sites More sharing options...
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