Great Britain issues warnings on adult use of antidepressants

U.S. physicians hope any action here balances concern about side effects with the risk that patients in need might become unwilling to take the drugs.

By Victoria Stagg Elliott, AMNews staff. Feb. 7, 2005.

Recommendations by Britain's health agency that physicians restrict and monitor SSRI prescriptions for adults have U.S. doctors wondering if the Food and Drug Administration will follow suit.

The United Kingdom's Medicines and Healthcare products Regulatory Agency issued the new advice in December 2004. The agency warned that selective serotonin reuptake inhibitors should not be used to treat mild depression, that young adults older than 18 who are taking these drugs be closely monitored, that the lowest possible dose be used and that the drugs be discontinued slowly to avoid withdrawal reactions.

The recommendations build on advice the agency announced in December 2003 against the use of most of these drugs, except Prozac (fluoxetine), by those younger than 18 because of a lack of evidence of effectiveness in this age group and data suggesting significant side effects, including possible suicide risk.

In its most recent guidance, the U.K. agency concluded that these drugs were effective for adults and that the benefits outweighed the risk for those with major depressive disorder. "SSRIs are an important group of medicines, which help patients who suffer depressive illness," said Dr. Kent Woods, chief executive of the MHRA. "The benefits of SSRIs in adults are still considered to outweigh the risk of adverse drug reactions."

Many U.S. physicians are eager to see what the FDA will do in light of the MHRA's recommendations.

In March 2004, the FDA called on SSRI manufacturers to include stronger cautions on the labels regarding the possibility of suicidal thoughts among children and adolescents and a worsening of depression. In January of this year, it issued new medication guides and revised labeling warning that children and adolescents on the drugs should be monitored closely, particularly when initiating treatment. The new labeling also suggests that these risks could apply to adults.