British Warn on Antidepressants for Adults

LONDON, Dec. 6 - British medical regulators urged physicians on Monday to show greater caution in prescribing antidepressants to adults and said they should be clearly labeled with warnings about their use. Regulators did not dispute the benefits of the drugs for most adults, but the newest warning seemed to reflect a growing caution among British medical specialists about the use of antidepressants, particularly in cases of mild depression, and an equal sense that physicians should also consider counseling and other forms of psychiatric therapy.

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The warnings did not go as far as British rules a year ago that counseled against the use of six antidepressants - not including Prozac, made by Eli Lilly & Company - to treat depression in patients younger than 18. Those rules led to similar recommendations by United States health authorities last September.

The Medicines and Healthcare Products Regulatory Authority - the British equivalent of the United States Food and Drug Administration - said that while selective serotonin reuptake inhibitors, known as S.S.R.I.'s, were "effective medicines in the treatment of depression and anxiety conditions" in adults, "clear advice" should be given "in all S.S.R.I. product information" about withdrawal reactions, dose changes and suicidal behavior.

Alison Langley, a spokeswoman for the authority, said this guidance related to the level of information physicians should give to patients.

In a letter sent to physicians on Monday, the British authority said: "There is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over" using S.S.R.I.'s. "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 S.S.R.I.'s should be closely monitored."

The authority took particular issue with an antidepressant that is not an S.S.R.I., Efexor, which is made by Wyeth and marketed in the United States as Effexor, because of its concerns about heart damage and a heightened danger from overdose. It said treatment with the drug, 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 patient." The drug should not be used in patients with heart disease, it said.

Efexor accounted for $2.7 billion in sales last year and is Wyeth's top-selling drug. The company said in a statement that it would challenge the decision. Its shares fell $1.29, or about 3 percent, to $40.27 in New York.

In separate guidelines, the National Institute for Clinical Excellence, which is part of the state-financed National Health Service and issues rulings on treatments and care, said that antidepressants should not be used at all in the initial treatment of mild depression because "the risk-benefit ratio is poor."

"These guidelines recognize that while medication has an important role to play in treating these conditions, there are also many effective alternatives," said Andrew Dillon, the chief executive of the institute, referring to psychological therapies.

However, the guidelines said, in moderate and severe depression, patients should be treated with S.S.R.I.'s rather than an older generation of antidepressants called tricyclics. The agency cautioned that although the newer medications were "not associated with tolerance and craving," patients could suffer withdrawal if they reduced their dosage or stopped taking the drugs.