U.K. Regulatory Agency Advises Limiting Use of Antidepressants in Adults
The British National Institute for Clinical Excellence on Monday recommended that antidepressants not be used as a first-line treatment for mild depression, citing concerns of possible side effects and withdrawal symptoms, the Washington Post reports. According to NICE, patients who report symptoms of mild depression but are able to work and function normally should be instructed first to try exercise, self-help or talk therapy or wait a couple of weeks to see if their conditions improve. The regulatory panel is the same one that issued warnings last year about the increased risk of suicidal behavior in children who take antidepressants (Vedantam, Washington Post, 12/7).
In a letter sent to physicians on Monday, Britain's Medicines and Healthcare Products Regulatory Authority stated, "There is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over" who use selective serotonin reuptake inhibitors. The letter continued, "But individuals mature at different rates, and young adults are at a higher background risk of suicidal behavior than older adults, so as a precautionary measure, young adults treated with SSRIs should be closely monitored." In addition, MHRA said that although SSRIs were "effective medicines in the treatment of depression and anxiety conditions," in patients ages 18 and older, "clear advice" should be given "in all SSRI product information" about suicidal behavior, dose changes and withdrawal symptoms. (Cowell, New York Times, 12/7).
Stephen Pilling, a British scientist who directed the development of NICE's guidelines, said, "I am confident we have taken the right line. We're not saying, 'Don't use drugs.' We are saying, 'Use them appropriately.'"
Carol Goodheart, co-chair of an American Psychological Association task force on evidence-based practice, said, "There are some cultural differences in that, in this country, medications are prescribed for many disorders and problems in living. It may be that the British are more conservative than the Americans in prescribing drugs" (Washington Post, 12/7).
Andrew Dillon, CEO of NICE, said, "These guidelines recognize that while medication has an important role to play in treating these conditions, there are also many effective alternatives."
MHRA also issued specific warnings about Wyeth's antidepressant Effexor because of concerns over the increased risk of overdose and heart damage. Treatment with Effexor, which is a selective serotonin and norepinephrine reuptake inhibitor, "should only be initiated by specialist mental health practitioners [and] there should be arrangements in place for continuing supervision of the patients," MHRA stated (New York Times, 12/7).
The recommendation stated that patients who were being treated successfully with the medication should finish their course of treatment, but patients with heart problems should not be given the treatment.
Allison Jeynes-Ellis, Wyeth's medical director in the United Kingdom, said, "Restricting access to medication is not in the best interest of patients and is a backward step in the treatment of depression in this country." Wyeth said patients who took Effexor had a higher rate of side effects because the treatment was prescribed to "very sick patients after other drugs had been ineffective," according to the Post. Company officials said the side effects could be attributed to patients' other conditions, rather than Effexor (Washington Post, 12/7). In a statement, Wyeth said it will challenge the recommendation and asked that MHRA accept the company's earlier recommendation for labeling, patient information and packaging to reduce risks of overdose and suicide (Agovino, AP/New Haven Register, 12/6).
FDA on Monday said it requested new data from Wyeth on Effexor and will review it as soon as possible, as well as "work with the MHRA to fully understand the basis for their decision," the Post reports (Washington Post, 12/7). The NICE guideline is available online. You must have Adobe Acrobat Reader to view the document.