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The McClatchy Co.

Local News Sunday, October 17, 2004

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Depression drugs to be distributed with warning label
FDA says 'black box' should warn of dangers for children

By Jason Cato The Herald
(Published October 16‚ 2004)

Antidepressants will now come with double-barrel warnings meant to get the attention of doctors and parents: These drugs can and do cause some children to become suicidal.

The U.S. Food and Drug Administration on Friday acted on a month-old recommendation from its own expert panel and will require "black box" warnings for all antidepressants.

A black box warning is the government's strongest safety alert. It's one step below a ban.

The label warnings will stress the importance of closely monitoring children and adolescent patients started on these drugs for the emergence of suicidal thoughts or behavior.

That message also will come in the form of a medical guide that pharmacists will be required to give patients with all antidepressant prescriptions. The guide will be required to be distributed with sample packets.

Impact on Pittman case

Critics who've long fought for such warnings, including attorneys for a boy facing double murder charges in Chester County, called Friday's actions a step in the right direction. Still, many questioned what took the FDA so long to act.

"It's taken far too long, but I'm thrilled by it," said Karen Barth Menzies, an attorney from Los Angeles who represents Christopher Pittman, the boy charged with killing his grandparents at their Chester County home in 2001. "People have just been buying the idea for so long that these drugs are good for anything and everything. We now know that isn't true. But it's just another example of the FDA failing to act sooner."

Dr. Lester Crawford, the FDA's acting commissioner, said in a written statement that Friday's actions "represent 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," Crawford said.

The American Academy of Pediatrics applauded the FDA's decision.

"Pediatricians support stronger warnings, including the black box, as we now know there is definitely an increased risk of suicidal thinking and behavior in children who are on these drugs. The labels needed to change," said AAP President Dr. Carol Berkowitz in a written statement "However, we still believe that for the most serious cases of depression or other psychiatric disorders, these medications can help adolescents following appropriate diagnosis, an explanation of the risks and benefits to the patient and family, and specific guidelines for monitoring."

An official with GlaxoSmithKline, the British drug giant that makes the antidepressant Paxil, told the Associated Press that the company sees the warnings as a positive action.

"We agree with the FDA that providing additional information to everyone -- from health care professionals to parents and patients -- is one of the most positive steps that can be taken to advance the diagnoses and treatment of adolescents with depression," said Mary Anne Rhyne from the company's office in Raleigh, N.C.

The end result left victims, scientists and advocates giddy with happiness and claiming victory, but many strongly disagreed with Crawford's assertion that the actions were based on the latest and best science.

"The FDA fought every step along the way until they couldn't hold out any longer," said Vera Hassner Sharav of the Alliance for Human Research Protection. "I see this as a victory, but the antidepressant issue is a demonstration of how the system is dysfunctional."

The British government in December, using the same clinical trial data provided to the FDA, all but banned antidepressants from being used with children. In the 10 months since, the FDA has held two advisory panel meetings to explore the issue of antidepressants in children, including one in September that led to the black box warning recommendation; a Congressional investigation subcommittee has held two hearings looking into what the FDA knew about the dangers of antidepressants and when; and the New York attorney general sued Glaxo for withholding data from clinical trials that demonstrated its drug was either dangerous or not effective in treating depression in children.

Questions about the safety of antidepressants first arose in the early 1990s, just years after Prozac, the first of the antidepressant "wonder drugs" known as selective serotonin reuptake inhibitors, was approved. An FDA hearing in 1991 concluded that no credible evidence existed to show Prozac could lead adult patients to become suicidal or homicidal.

Dr. Richard Kapit, a retired FDA scientist who reviewed Prozac, Paxil and Zoloft in the late 1980s before the antidepressants were approved to treat depression in adults, said that he suspected the drugs could cause people to become suicidal or homicidal from the beginning. Those risks, however, did not outweigh the potential benefits of the drugs, he said.

"I had always thought the drugs had the potential to cause manic episodes, and manic episodes are frequently accompanied by violence," said Kapit, who will testify for the defense at Pittman's trial. "When I reviewed Prozac in the 1980s, I accepted that in rare patients it could cause patients to become manic, suicidal. I don't think I doubted, or anyone doubted, in rare patients that could be true.

"Now we have hard data to back up what everyone sort of believed, that these drugs are capable of causing manic states."

Of the 24 antidepressant clinical trials involving juveniles reviewed by the FDA, 22 failed to show the drugs were any more effective than a placebo. A review of the same trials by a Columbia University team hired by the FDA also showed that antidepressants can cause 2 percent to 3 percent of young patients who were not suicidal before taking the drugs to become so during the early stages of treatment.

Only Prozac has been approved by the FDA to treat depression in children. It was also the only drug not to be included in the British government's virtual ban.

However, all antidepressants are given to children through a legal practice known as "off-label" prescribing. Last year, more than 11 million antidepressant prescriptions were written for U.S. children, according to the FDA. A recent study showed as many as 89 percent of those were written for off-label, or non-approved, uses.

"In other words, almost 90 percent of the time children receive antidepressants that are not approved by the FDA for that child's condition," said Dr. Joseph Glenmullen, a psychiatrist at Harvard University. "To give a child a drug that can make them suicidal for conditions where there is nonexistent or inadequate proof that the drugs work is irresponsible and fails to protect our children.

"Surely, the FDA and the pharmaceutical industry know that even a black box warning will not adequately curtail prescribing unapproved antidepressants to children for unapproved conditions."

Glenmullen, who prescribes antidepressants, said the FDA should have banned doctors from prescribing the drugs for non-approved uses. He also said the FDA still has much work to do on the antidepressant issue.

Left to be explored, he said, is whether the drugs can cause adults to become suicidal and the role the drugs play in causing people to become violent and/or homicidal.

"And that goes right to the Christopher Pittman case," Glenmullen said.

Pittman is charged with shooting Joe Frank Pittman and Joy Roberts Pittman while they were in bed in November 2001 before setting the house on fire and fleeing in a family vehicle. He was 12. Now 15, Pittman will be tried as an adult and could be sentenced to life in prison if convicted. A trial date has not been set.

The boy had been on a five-week regimen of Paxil and Zoloft. His attorneys will contend an adverse reaction to his antidepressant medication caused his violent behavior. Friday's move by the FDA strengthens that position, they said.

"We know it's been established that Zoloft causes kids to commit suicide," said Andy Vickery, a Houston attorney representing Pittman. "It's not a big leap to homicide. It's the other side of the same coin. It's caused by the same biological mechanism."

Vickery said he is encouraged by the FDA's action but wondered whether things would have been different had the warnings come three years ago.

"That would have been before Christopher got Zoloft from a general practitioner for an unapproved use," he said. "Two things might have happened. The doctor may not have given it to him, or he might have provided them with the appropriate warnings."

Jason Cato • 329-4071


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