Group Says Wyeth Failed To Warn About Homicidal Thoughts

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Group Says Wyeth Failed To Warn About Homicidal Thoughts

(July 9, 2006) -- An antidepressant that Andrea Yates had been taking before she drowned her five children in 2001 has recently been found to possibly increase the risk of homicidal thoughts, according to a medical watchdog group that says Effexor's manufacturer has not warned the public.

"Homicidal ideation" was added last year as one of the drug's rare adverse events on Effexor XR's label and on Wyeth's Web site.

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The U.S. Food and Drug Administration defines rare as occurring in less than one in 1,000 people. In the U.S. alone, about 19.2 million prescriptions for Effexor were filled last year, but that does not reflect the number of people who take the drug because some of those are refills.

Dr. Moira Dolan, executive director of the Medical Accountability Network, said she discovered the labeling change about two weeks ago when she stumbled across the FDA's MedWatch newsletter from November. The Madison, N.J.-based drug company did not send letters to doctors or issue warning labels.

"People need to be warned that this is a possible side effect," Dolan, an Austin doctor who has reviewed Yates' medical records but is not involved in the case, said Sunday. "Families don't know to be aware of this possible effect. As doctors, we're not going to look through 36 pages of labeling."

Effexor is Wyeth's top-selling drug, with $3.46 billion in 2005 sales worldwide, more than twice the total for its No. 2 product and 18 percent of its total revenues for last year.

"We believe there is no causal link between Effexor and homicidality," said Wyeth spokeswoman Gwen Fisher. "In our minds, we've taken every precaution."

She said that as Effexor was being studied for use in treating panic disorder, Wyeth found that only one person reported having homicidal thoughts in its clinical trial. Fisher said she did not know the trial date.

In approving Wyeth's application to use Effexor for that disorder, the FDA wanted homicidal ideation listed as a rare adverse event, defined as something not proven to be linked to the drug, Fisher said. That is different from an adverse reaction, she said.

Wyeth never notified doctors or issued warning labels because it found no causal link between its drug and homicidal thoughts, Fisher said.

Dolan said the current Web site label mentions homicidal thoughts in the middle of a paragraph on page 36. Fisher said the warning about "homicidal ideation" also appears on the one-page package insert given to all patients.

In 2004, the FDA ordered that all antidepressants carry "black box" warnings that they increase the risk of suicidal thinking and behavior in children. That action was driven by data that showed that, on average, 2 to 3 percent of children taking antidepressants have increased suicidal thoughts and actions. The link is stronger with Effexor than with other antidepressants in the same class of drugs.

James T. O'Donnell, assistant professor of pharmacology at Rush University Medical Center in Chicago and the author of "Drug Injury: Liability, Analysis, and Prevention," said the homicidal ideation issue should be on the same level of public awareness.

"For something as final as homicide, that's important to know about," O'Donnell said.

But Fisher said the drug is safe and effective. Yates, who remains jailed, continues taking Effexor as well as an anti-psychotic drug to help stabilize her mental illness, according to a psychiatrist testifying in Yates' retrial that started two weeks ago.

Yates, 42, has pleaded innocent by reason of insanity in her second murder trial. Her 2002 capital murder conviction was overturned on appeal because some erroneous testimony may have influenced jurors.

Yates had been prescribed Effexor in varying doses since shortly after her first suicide attempt in 1999, said Dolan, who reviewed her medical records after her first trial at the request of her then-husband, Rusty Yates. A month before the murders, her daily dose had increased to 450 mg, twice the recommended maximum dose, Dolan said.

Her lead attorney, George Parnham, has criticized the amount of medications Yates was prescribed before the children's bathtub drowning deaths. He said Wyeth should have publicized information about the possible connection between Effexor and thoughts of murder, but he said that will not affect Yates' case.

"Obviously this is a severely mentally ill individual who was on a plethora of psychiatric meds," Parnham said. "There's no question mental illness killed those children."

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Parnham said Yates suffered from postpartum psychosis and drowned the children in the family bathtub while in a delusional state, which likely was exacerbated after she was suddenly taken off Haldol, a strong anti-psychotic drug.

Yates, being tried in only three of the deaths, will be sentenced to life in prison if convicted.

Effexor sales rose only 3.3 percent in 2005, compared with 2004, but jumped 8.8 percent in the first quarter of this year, to $945 million.

Read Wyeth's Response

Source: AP

Last updated: 7/06

Group Says Wyeth Failed To Warn About Homicidal Thoughts

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