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Parents encouraged after FDA testimony

[2/16/04]Two weeks after their testimony before an FDA advisory panel, Dr. Gary Cheslek and his wife, Linda, are encouraged that at least warnings may be given before physicians prescribe pills containing SSRIs to patients especially young patients.

Cheslek, a Vicksburg dentist, and his wife, a pediatric nurse practitioner, believe their son, Justin, took his own life three years ago after one of the pills, Effexor, triggered irrestible mental impulses.

Both were allowed 2 minutes each before a committee of physicians, psychologists and other professionals brought together by the federal Food and Drug Administration in Bethesda, Md.

The committee took their testimony about a class of drugs called selective seratonin reuptake inhibitors. Other brand names in the class include Prozac, Zoloft and Paxil.

There were speakers there who talked about the benefits the drugs have been to themselves and their children and others explaining the FDA’s stance.

From the FDA officials, Cheslek said, they got what he termed “psychobabble.”

“Well, we are not sure what we’re seeing here … We think there may be …’ They use euphemisms. There may be a signal.’ And I wanted to get up and say, What in the hell are you doing when 60 parents told you their kids crashed and burned out there and you think there’s a signal?” he said.

The reaction from the 40-member advisory panel was much more encouraging, Cheslek said. That group came out flatly and said there should be warnings placed on the product information sheets that accompany the SSRIs to warn physicians, pharmacists and patients of the possibility a small group of people may have suicidal or violent reactions.

A soccer player, kayaker and college student, Justin had gone to a neurologist because of headaches that had plagued him since high school. The medication he was taking to prevent the migraines apparently interfered with his sleeping, so he went to the University of Southern Mississippi Health Center in February 2001 where a doctor prescribed the sleep aid Ambien. When he complained that the medication left him draggy and out of sorts all day, he was placed on Paxil. Two weeks later he was changed to Effexor, and on March 15 he was found dead by suicide in his apartment.

The physicians all agreed he was not depressed, nor did he show any self-destructive tendencies.

“When Justin died, we didn’t have a clue,” Cheslek said. “He was off at school. We knew he was on Paxil. Didn’t know he had been switched to Effexor. Didn’t have a clue that these medications had a history.”

It was not until August 2001 that Cheslek read of a class action suit in California with Paxil regarding withdrawal. Subsequent research led the Chesleks to the information that there was a whole list of side effects from the SSRIs that included suicidal tendencies in some people, especially young people.

“There has been a controversy over these medications since the early ’90s,” he said. “An FDA review was done in 1991 because of the number of suicides being reported in adults with this medication.”

He said not only were the studies of the effectiveness of the drugs flawed, but, since the FDA does not do the testing, the studies are really marketing studies to sell the drug to the FDA.

Also, Cheslek said, other countries have placed restrictions on SSRIs. However, in the United States, no warnings or restrictions are in place, although one manufacturer has issued a voluntary advisory.

Until last summer, he said, there had been no testing of SSRIs in children.

“When they ran the tests, they found two things. One, it doesn’t work with kids. And two, they saw a two- to three-fold increase in the suicide rate and violence,” Cheslek said.

Those findings spurred the FDA to call together the 40-person advisory group to make a recommendation on what to do. Also, the FDA has commissioned Columbia University to get the original information from seven drug companies and examine it with an eye toward looking for adverse reactions.