Antidepressants Might Get Tougher Labels

Advisers to the government want to warn young adults about the risk of suicidal thinking and behavior.
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Medical advisers to the federal government say drug companies should strengthen the labels on antidepressants to warn young adults about the possible increased risk of suicidal thinking and behavior.

The advisory panel's recommendation, issued late Wednesday, would be similar to warnings that now apply to children and adolescents. Many psychiatrists worry tougher labels could discourage patients from seeking help.

The potential impact of stronger warnings on drugmakers is uncertain, although the yearly growth rate in U.S. prescriptions for the newest and most popular antidepressants has been slowing for several years.

Many of the drugs reviewed by the advisory committee of the Food and Drug Administration have lost patent protection, including Zoloft from

Pfizer

(PFE) - Get Report

, Prozac from

Eli Lilly

(LLY) - Get Report

and Celexa from

Forest Laboratories

(FRX)

.

The advisory panel voted 6-2 that the FDA should place a black box warning -- the agency's strongest alert -- on antidepressants, saying adults under 25 have an increased risk of exhibiting suicidal thoughts and behavior. Panel members also said the labels should include language about the need for treating depression.

The FDA doesn't have to follow suggestions of its advisers, but it usually does so. The panel meeting was held to review an FDA analysis of 372 clinical trials, going back to the mid-1980s, that tested nearly 100,000 people.

Two years ago, a pair of FDA advisory panels recommended adding the strongest warning

about the risk of increased suicidal thinking and behavior among children and adolescents. In October 2004, the agency agreed.

Black box warnings make doctors more cautious about prescribing medications and patients more careful about taking them. Such warnings usually hurt drugs' sales, especially if competing products don't carry the warning. It's clear that any action by the FDA will be across-the-board, just like 2004 when 34 products received black box warnings.

"It is important to draw lessons from previous pediatric warnings and ensuing media coverage that created barriers to care and unnecessarily scared families away from treatment," said the American Psychiatric Association and a coalition of 14 medical and patient-support groups before the advisory panel voted.

There is some indication that medical and regulatory debates in 2003 and 2004 leading to black box warnings for the youngest patients reduced the use of antidepressants.

Medco Health Solutions

(MHS)

, the big pharmacy benefits manager, detected a 10% drop in the proportion of patients under 18 taking an antidepressant in 2004 compared with 2003. Between 2002 and 2003, there was a 9% increase.

The medical data research firm IMS Health says there's been a slowing growth rate in total U.S. prescriptions for the newest and most popular antidepressants. In 2002, total prescriptions rose 14.7% from the previous year. Between 2003 and 2004, the growth rate was 4.7%. Last year it was 1.7%.

The growth rate has slowed even as cheaper generics have entered the market. Of the 11 antidepressants reviewed by the FDA for the advisory committee meeting, only two still retain patent protection, Lexapro from Forest Laboratories and Cymbalta from Eli Lilly.

However, some companies have created extended-release versions of their original products, extending patents and sales. For example,

Wyeth's

(WYE)

Effexor XR is an extended-release version of Effexor. The older drug became subject to U.S. generic competition in August.

GlaxoSmithKline's

(GSK) - Get Report

Wellbutrin-XL is an extended-release version of the now-generic Wellbutrin.

The FDA said its analysis of 372 clinical trials showed the risk of suicidal thinking and behavior was higher for young adults under 25 who took antidepressants versus those who took a placebo. From ages 25 to 64, the risk between drug groups and placebo groups was the same. The risk was less for people 65 and older, leading the FDA to wonder if antidepressants offered "perhaps even a protective effect in elderly depressed patients."

The FDA staff review of clinical trials was issued last week, using a statistical technique called meta-analysis. This enables researchers to combine similar studies to determine if there are broader themes that wouldn't be picked up in individual studies. When the agency analyzed data on children and adolescents several years ago, it looked at 24 studies involving 4,400 people.