October 26

FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald

FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald

Wed, 29 Oct 2003

The Washington Post correctly reports:
“The association between antidepressants, particularly the selective serotonin reuptake inhibitors (SSRIs), and suicide has been controversial since the first SSRI, Prozac, came on the market in the late 1980s.” But stakeholders in this profitable enterprise have until recently succeeded in concealing the documented evidence.

Given that two to three times as many children taking SSRIs in controlled clinical trials conducted by these drugs’ manufacturers exhibited suicidal behavior compared to those taking sugar pills, and given FDA’s acknowledgment that antidepressants have no demonstrable benefit above placebo for children, it is difficult to fathom FDA’s timid inaction and failure to protect children from harm.

The FDA’s failure to issue any meaningful restrictions to guide physicians and the public contrasts sharply with the responsible precautionary action taken by the British Medicines Healthcare Products Regulatory Agency (MHRA, the equivalent to the U.S. FDA). Whereas the MHRA acted to protect children by restricting the use of SSRIs in children, the FDA failed to use its authority to protect children. FDA is postponing any action that would curtail drug industry profits–even as such inaction may result in additional preventable suicides.

It is hard to argue with Lisa Van Syckel who says her daughter became suicidal on Paxil: “parents can’t rely on the government or anyone else to monitor children who are prescribed antidepressants.”

For links to documents about this controversy see: www.ahrp.org



FDA Cautions on Antidepressants and Youth

By Marc Kaufman

Concerned about studies that showed antidepressants may be leading some adolescents and children to suicidal activity, the Food and Drug Administration issued a public health advisory yesterday telling doctors to be especially careful in prescribing the drugs.

The agency, which has been overseeing studies into the effects of eight popular antidepressants on patients under 18, said the data does not clearly establish an association between the drugs and suicide. But it also said that a increase in suicidal behavior in young people taking the drugs cannot be ruled out.

Thomas Laughren, the FDA’s team leader for psychiatric drug products, said the agency has found enough reason for concern to request additional information from the drug companies that make antidepressants, and to schedule an expert advisory committee hearing on the subject for February.

“We’re not saying these drugs can’t be used” with children and adolescents, Laughren said. “We’re saying one should proceed with caution. . . . Once we analyze the data more fully, we’ll be in a better position to make a more formal recommendation.”

Only Prozac has been approved by the FDA for use in adolescents and children — having shown an effectiveness that others have yet to show — but doctors often prescribe other antidepressants for youngsters.

The concern over antidepressants and adolescent suicidal behavior was sparked this summer in Britain, when health regulators warned doctors not to prescribe the antidepressant Paxil for people under 18 years old because data showed a heightened suicide risk. Those patients were diagnosed with major depression.

The FDA issued its own warning for Paxil soon after and then asked the makers of eight antidepressants to give them more information about suicidal behavior by teens using their drugs. Last month, Wyeth Pharmaceuticals sent out letters to doctors saying that clinical studies on its antidepressant, Effexor XR, had found an increased incidence of “hostility and suicide-related adverse events, such as suicidal ideation and self-harm.”

Laughren said that some of the data “signaled” a possible association between antidepressants and increased suicidal behavior, but that it wasn’t specific enough to come to any firm conclusions. The agency has now asked the companies for specific information on the 4,100 patients who participated in 20 clinical studies of young people taking antidepressants.

Detailed information on how many young people are taking antidepressants is unavailable, but experts agree that the practice is on the rise. Mark Olfson, an associate professor at Columbia University’s College of Physicians and Surgeons, published a study last year that estimated that in 1996, 1 percent of children under 18 were using an antidepressant.

At the same time that the FDA and others are voicing increased concern about the effects of antidepressants on adolescents, Laughren, Olfson and others also note statistics showing that the overall rate of teen suicide has declined over the past 15 years. Studies have not been done to test whether antidepressant use is contributing directly to the decline in teen suicides, but the researchers say a correlation is possible.

“I think the FDA needs to be cautious about attributing particular adverse effects to a potentially helpful medication for the general public,” said David Shaffer, chief of child and adolescent psychiatry at Columbia University. “Adolescents are a population where suicidal [thinking] is quite common, and we have to be sure that the data isn’t just picking up that reality.”

Shaffer said that the federal studies have typically shown that around 20 percent of American teens think about suicide, or act out such thoughts, some time during a year.

The association between antidepressants, particularly the selective serotonin reuptake inhibitors (SSRIs), and suicide has been controversial since the first SSRI, Prozac, came on the market in the late 1980s. An FDA expert advisory panel studied the issue of antidepressants and suicide in adults in 1991 and concluded that there was no association, although some lawsuits continue to allege a connection. Researchers such as Shaffer say they see no reason SSRIs should have significantly different effects on young people than on adults.

Doctors continue to increase the number of antidepressant prescriptions they write each year. According to IMS Health, which collects information on drug prescribing patterns, antidepressants make up the second-largest class of drugs prescribed in the United States. They report that more than 136 million prescriptions for antidepressants were filled between mid-2002 and mid-2003, an increase of 13 percent over the previous year.

© 2003 The Washington Post Company

October 28, 2003
F.D.A. Intensely Reviews Depression Drugs

The Food and Drug Administration issued a public health advisory yesterday that makes clear that the agency has grown increasingly skeptical that there is any link between antidepressant use and the risk of suicide in teenagers and children.

“I think probably that we have backed off a little bit from the advisory issued in June, which recommended against using Paxil,” said Dr. Thomas Laughren, a psychiatrist and an F.D.A. official. “I believe our position now is that we just don’t know.”

The F.D.A. plans to convene a panel on Feb. 2 to examine the relationship between suicide and antidepressant drug therapy. The panel will be asked to decide if the drugs should be prescribed to teenagers and children, if the drugs’ warnings sections should be changed, and what studies should be done to determine if there is a link between antidepressant use and suicide in teenagers and children.

To prepare for the meeting, the agency is undertaking an intensive review of pediatric studies of the drugs. In clinical trials of Paxil, it was found that children given the drug were more likely than those given inert pills to attempt suicide. The studies also found that the drug did not improve depressive symptoms in the subjects.

As a result, the F.D.A. warned in June that physicians should avoid prescribing Paxil to children and teenagers. Paxil, manufactured by GlaxoSmithKline, is among a class of drugs called selective serotonin reuptake inhibitors that also includes Prozac and Zoloft.

The advisory committee meeting in February will probably be controversial. The F.D.A. convened a similar panel in 1991 to discuss claims that Prozac and similar pills might lead adults to become suicidal. The panel was mobbed by spectators and heard hours of testimony from people who thought they or their loved ones had become violent or suicidal after taking Prozac.

The 1991 panel ultimately voted that there was no compelling evidence linking the drugs with an increased risk of suicide. In recent interviews, 7 of the 10 panel members said that since disclosure of the Paxil studies, they would consider changing their votes.

The F.D.A. plans to re-examine many of the clinical conclusions made during studies of the drugs. For instance, some teenagers and children may have been incorrectly labeled as attempting suicide. “A number of the cases seem doubtful,” Dr. Laughren said. One girl was labeled as being suicidal after repeatedly slapping herself, Dr. Laughren said. Others were labeled suicidal after cutting themselves, he said.

The agency has also asked the drug companies to provide complete clinical histories on its trial participants to determine whether those given antidepressants may have been, in aggregate, at greater risk of committing suicide than those given inert pills. If so, the larger number of suicidal events among those given antidepressants could be explained by their increased suicidal tendencies and not to the drugs.

The agency also released a health advisory yesterday reminding doctors that among antidepressants, only Prozac had proved effective in treating pediatric depression. The agency also noted that the drugs should be used with caution and that patients should be closely monitored during initial drug therapy.

Copyright 2003 The New York Times Company

FDA advisory urges caution in children’s use of antidepressants
By Jason Foster The Herald
(Published October 28, 2003)

Two antidepressants that will be a key focus in the trial of a Chester County teen accused of killing his grandparents were among the drugs listed in an advisory released Monday telling doctors to exercise caution in prescribing them. The U.S. Food and Drug Administration recently completed a preliminary review of reports for eight antidepressants, classified as selective serotonin reuptake inhibitors. The studies found an excess of suicidal thoughts or behavior in clinically depressed patients using several of the antidepressants compared to those using a placebo. The drugs studied were citalopram, fluoxetine (Prozac), fluvoxamine, mirtazapine, nefazodone, paroxetine (Paxil), sertraline (Zoloft) and venlafaxine. Pittman took Zoloft, Paxil Christopher Pittman, 14, accused of killing Joe Frank and Joy Roberts Pittman in 2001 when he was 12 years old, was on Zoloft at the time of the killings. Christopher previously was on Paxil. His father, Joe D. Pittman, has said the drugs can be blamed for his son’s violent behavior. The FDA has determined that additional data and analysis, as well as public discussion, are needed, according to the advisory. Thomas Laughren, the FDA’s team leader for psychopharmacological drugs, told The Washington Post the FDA isn’t suggesting the drugs can’t be used in patients under 18. “We’re saying one should proceed with caution,” he told the newspaper. “Once we analyze the data more fully, we’ll be in a better position to make a more formal recommendation.” Only Prozac has been approved by the FDA for use in adolescents and children. The nonprofit group International Coalition for Drug Awareness is pushing for Congressional hearings into potential hazards of children using antidepressants. The FDA is scheduled to hold an advisory meeting Feb. 2. The coalition will attend and present the Pittman case as an example that Zoloft should not be prescribed to children, said Lisa Van Syckel, the group’s New Jersey coordinator.

Van Syckel said Monday the FDA advisory wasn’t explicit enough in speaking to the dangers of antidepressants among children. She said the advisory “sugar coats” the problem. “They’re not painting the full picture. The FDA wasn’t bold enough,” she said. “They didn’t have the strength and the courage to tell the truth.” Van Syckel cited studies of antidepressants in England that led the British government to ban Paxil from use in children due to increased tendencies of suicide and violence. Van Syckel will put her statement for the February hearing with the FDA on video and will read The Herald’s recent two-part series on the Pittman case, she said. “It brought me to tears,” she said of The Herald’s series, which concluded Monday. “I’m hoping to bring at least two or three members of that advisory panel to tears.”

Above all, Van Syckel said parents can’t rely on the government or anyone else to monitor children who are prescribed antidepressants. “We as parents need to do it ourselves,” she said. “We need to keep our children safe and we need to keep the children around them safe.”

Contact Jason Foster at 329-4066 or jfoster@heraldonline.com. 2 of the drugs will be focus in upcoming Pittman trial

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