Friday, October 15, 2004

The Food and Drug Administration yesterday ordered the makers of all antidepressants to include tough warnings that the drugs may increase the risk of suicidal thoughts and attempts in some children and teens.

FDA officials held two press conferences to announce that all antidepressants must carry a so-called “black box” warning to that effect, the government’s strongest possible safety alert.

The announcement comes when the FDA is under fire about its response to a severe flu vaccine shortage and for what critics, including some in Congress, have described as its delayed response in addressing concern about the safety of antidepressant use by minors.

At one press conference yesterday morning, acting FDA Commissioner Dr. Lester Crawford said the agency sought to balance the increased risk of suicide posed by the drugs against their known benefits for treating depression in children.

“We continue to believe … that these drugs provide significant benefits for pediatric patients,” he said. “Today’s action represents FDA’s conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them. Our conclusions are based on the latest and best science.”

The FDA cited data from 24 placebo-controlled trials involving nine different antidepressants that showed children taking the drugs had a 4 percent risk of thinking of or attempting suicide, twice the 2 percent risk of those on placebos. No suicides occurred in those trials.

Researchers found that Prozac, Celexa and Zoloft posed lower risks for youngsters, while Luxor, Effexor and Paxil had higher risks.

In a teleconference with reporters late yesterday, Dr. Sandra Kweder, acting director of the FDA’s Office of New Drugs, vehemently denied that the agency has dawdled in dealing with the deadly problems associated with some of these drugs in children.

“The first evidence of a potential risk [that some children taking the drug think more about killing themselves or try to do it] came in May 2003. Before that, no one had conducted studies. The record shows we’ve acted vigorously. Since May 2003, we’ve issued four public health advisories on this,” Dr. Kweder said.

Some were caught off guard by the announcement that warning labels must go on all antidepressants. In the past, concerns have focused mostly on a category of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs.

SSRIs, the most popular antidepressants with adults, include medicines such as Paxil, Prozac and Zoloft.

Dr. Russell Katz, director of the FDA’s division of neuropharmacological drug products, said risks of suicide have been linked to other antidepressants besides SSRIs.

“So we thought it best to apply the warning to all drugs,” he said.

As a result of the new order, warning information must be written in bold letters and highlighted in a black box. The warning must also state whether a drug has been approved for use in children. As of now, only Eli Lilly & Co.’s drug Prozac has been approved as a treatment for depression in children.

The American Psychiatric Association yesterday said the box warning would put patients “seriously ill” with depression, who might otherwise benefit from the drugs, “at great risk.”

A senior FDA official told a stormy congressional hearing three weeks ago that the agency was likely to require a black-box warning on antidepressants regarding their potential for increasing suicidal thinking and behavior in children.

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