Associated Press: More Details about FDA Warning Strattera Associated with Suicide

Associated Press: More Details about FDA Warning Strattera Associated with Suicide

Thu, 29 Sep 2005

On April 26, 2004, we wrote: “The Alliance for Human Research Protection is concerned that children who are prescribed the failed antidepressant, Strattera, may be exposed to undisclosed serious risks of harm.

FDA’s-approved label states: “STRATTERA was administered to 2067 children or adolescent patients with ADHD and 270 adults with ADHD in clinical studies. Yet, adverse effects analysis included only 427 children on Stattera, and reported withdrawal of only 15 of 427 children on Strattera compared to 4 out of 294 children given a placebo. See: http://www.fda.gov/cder/foi/label/2002/21411_strattera_lbl.pdf

What happened to the other 1,640 children who were administered Strattera?

AHRP questions FDA’s inexplicable failure to include Strattera data in Dr. Andrew Mosholder’s analysis of antidepressants – and we question the exclusion of Strattera from FDA’s antidepressant drug advisory warning (March 22, 2004).” See: http://www.ahrp.org/infomail/04/04/26.php 

Our concerns have been validated.

The Associated Press reports today: “Eli Lilly said it provided the FDA results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, but survived, company and FDA officials said.”

Were these clinial trials conducted after the FDA had approved the drug? If they were conducted before approval–why were the suicide attempts not disclosed?

“Lilly warned doctors in December to stop using Strattera in patients with jaundice or who show signs of liver problems, and it placed a warning on the label and in prescribing information after at least two patients on the medication developed liver problems.”

Despite the warning, Dr. Thomas Laughren said, “FDA still views Strattera as an effective drug.” Similarly, Alan Breier, Lilly’s chief medical officer, stated: “Lilly continues to view Strattera as a safe and effective treatment option.”

What is the current standard for a medicine to be declared “safe and effective? How does the FDA justify exposing children to the risk of suicide and liver damage, and a host of yet to be disclosed adverse effects, from a drug prescribed for a questionable, non-life-threatening condition? Are children being put in harm’s way just to maintain profit margins?

Contact: Vera Hassner Sharav
212-595-8974

http://ap.tbo.com/ap/breaking/MGBOPITC7EE.html

Thursday, September 29, 2005
FDA Warns ADHD Drug May Be Associated With Thoughts of Suicide in Some Young People
By John J. Lumpkin Associated Press Writer
Published: Sep 29, 2005

WASHINGTON (AP) – The Food and Drug Administration warned doctors Thursday about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug used to treat attention deficit hyperactivity disorder.

Manufacturer Eli Lilly & Co. announced that a black-box warning will be added to the drug’s label in the United States. Such a warning is the most serious that can be added to a medication’s label, and similar warnings will be added to the drug’s labels in other countries. The company said a study showed instances of suicidal thinking were rare.

In a statement, the FDA said it “is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed.”

Eli Lilly said it provided the FDA results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, but survived, company and FDA officials said.

There was no evidence of increased suicidal thoughts in adults taking Strattera, which also goes by the generic name atomoxetine, the Indianapolis-based company said.

“The actual risk is very low,” said Dr. Thomas Laughren, head of the FDA’s psychiatric drug unit. Despite the warning, he said, “FDA still views Strattera as an effective drug.”

At the FDA’s request, Eli Lilly will publish a guide for doctors and pharmacists to give to people who are prescribed Strattera.

The warning is the result of a larger FDA review of psychiatric drugs and their possible association with suicide, the agency said. Old drug studies are being reviewed for occurrences of suicides and suicidal thoughts. Last year, the FDA ordered warnings on all antidepressants that they “increase the risk of suicidal thinking and behavior” in children who take them.

Strattera won praise from some doctors and parents when it became available because, unlike Ritalin, it is not a stimulant, a class of drug that can be addictive. But its chemical makeup is similar to certain antidepressants.

A review of other ADHD drugs is continuing, Laughren said.

About 3.4 million patients – adults and children – have been prescribed Strattera since it became available, with Lilly officials saying about 75 percent of those taking the medication are children.

Dr. Harold Koplewisz, a professor of child and adolescent psychiatry at the New York University School of Medicine, said that 19 percent of all teenagers have suicidal thoughts, making “suicidal thoughts in adolescents part of the normal experience.”

“There are 2,400 adolescents thinking about suicide for every one that commits suicide,” he said in an e-mail. “We are talking about a medication that may make some children and teenagers uncomfortable, which is very different than a lethal situation like a gun in a house.”

Still, he said, all children and teens taking psychiatric medication should be monitored.

Attention deficit hyperactivity disorder affects as many as 7 percent of school-aged children and 4 percent of adults in the United States.

Strattera’s worldwide sales have dropped lately, falling 31 percent to $123.5 million during this year’s second quarter from a year earlier.

Lilly warned doctors in December to stop using Strattera in patients with jaundice or who show signs of liver problems, and it placed a warning on the label and in prescribing information after at least two patients on the medication developed liver problems.

The company said Thursday it believes the drug is safe. “While suicidal thinking was uncommon in patients on the medication during clinical trials, it is important for parents to be aware it can occur, and to discuss any unusual symptoms with a physician, ” said Alan Breier, Lilly’s chief medical officer, in a statement. “Lilly continues to view Strattera as a safe and effective treatment option, and those doing well on the medication should be able to continue their treatment with confidence.”

Associated Press reporter Ashley M. Heher in Indianapolis contributed to this report.
FDA: www.fda.gov
Eli Lilly & Co.: http://www.lilly.com/
AP-ES-09-29-05 1420EDT

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