Wednesday, December 08, 2004

Regulators Suggest Restricted Use of Drug
Reuters story at Yahoo - "British regulators recommended 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. ... 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 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..."  
  

UK Tightens Antidepressant Rules, Curbs Wyeth Drug
Reuters Health story at Medscape - "British health authorities tightened warnings on selective serotonin re-uptake inhibitor antidepressants, or SSRIs, on Monday, urging doctors to use them sparingly and consider non-drug interventions, such as counseling. The Medicines and Healthcare Products Regulatory Agency, which reviewed the drugs after concerns over their safety, said there should be stronger warnings about the risk of withdrawal reactions after ending a course of treatment. Doctors should also, in most cases, prescribe only the lowest recommended dose of SSRIs, and young adults should be monitored closely as a precautionary measure when being treated, it added. No antidepressant is recommended for the initial treatment of mild depression." [Viewing Medscape resources requires registration, which is free].  
  

FDA Vows to Improve Drug-Safety Assessments
Story in Psychiatric News - "Serious concerns over how the FDA handled the highly publicized safety concerns surrounding antidepressants and Vioxx have prompted the agency to change course with respect to protecting public safety. Amid ongoing concerns that it has failed to protect the public health, the U.S. Food and Drug Administration (FDA) announced last month that it would take five steps toward strengthening the agency's drug safety programs. The move comes in the wake of ongoing Congressional inquiries into how the agency responded to and managed early concerns about the safety of antidepressants and the anti-inflammatory COX-2 inhibitor, rofecoxib (Vioxx)..." See also information on the FDA pilot program (Adobe Acrobat format) for resolving differences of professional opinion.