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Antidepressant prescriptions show decline

Drop follows FDA meeting on links to suicides in kids
Tuesday, May 11, 2004
BY ED SILVERMAN
Star-Ledger Staff

The number of new prescriptions written for antidepressants has dropped by 10 percent since a government meeting was held earlier this year to review suspected links to suicide.

Doctors wrote new prescriptions at a rate of nearly 1.1 million per week during early February, when a Food and Drug Administration panel met to explore scientific data. The meeting drew national publicity when some parents told how their children attempted or committed suicide after taking of one of the drugs. Prescriptions then began to drop.

By late March, the number rebounded, but dipped again after drug makers were told to put warnings on product labels. As of April 23, the number of new prescriptions per week was about 996,000, according to NDC Health, a market research firm that tracks prescription data.

"Depression still exists. I see it in my office every day," said Roy Boorady, an assistant psychiatry professor at New York University School of Medicine's Child Study Center. "But in talking to my colleagues, I know we've all been more cautious prescribing these medications."

The data also shows the total number of new and refilled prescriptions fell 6 percent over the same period, and is the latest indication that the controversy over antidepressants is widening.

The debate, however, is not clear-cut. Many parents and physicians say antidepressants are life-savers, which helps explain why the drugs generated more than $11 billion in retail sales last year. But critics say the alleged links to suicide, especially among children, demand greater restrictions.

The issue drew attention last summer after British medical authorities, citing previously unpublished safety data from pharmaceutical companies, urged physicians not to prescribe most of the medicines to children. Their list included Zoloft, Celexa, Paxil and Effexor, but not Prozac.

In an unusual response to growing pleas by American families, the FDA held an advisory panel in February. But after the meeting, the agency was criticized by consumer advocates for allegedly silencing its own medical reviewer, who wanted to propose restrictions on prescriptions, according to FDA documents.

In late March, the FDA told drug makers to issue warnings about suicide on product labeling and asked Columbia University researchers to review side effect data. A report is expected this summer. But the agency was chastised by angry parents for failing to take the same steps as their British counterparts.

As a result, the House Energy and Commerce Committee is investigating the FDA's handling of its medical reviewer. The agency denied silencing the reviewer and defended its decisions, but Rep. Joe Barton (R-Texas), who chairs the committee, said the agency's action raised "troubling questions" and that he may hold hearings.

The controversy, meanwhile, has renewed concern about off-label usage of drugs. Only Prozac was approved for children in the United States, but doctors can prescribe any medication. Drug makers are also under pressure to release unpublished clinical trial data, which critics say may contain negative information that would otherwise remain suppressed.

Ed Silverman can be reached at (973) 392-1542 or esilverman@starledger.com.




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