Prozac targeted by health group/Warning labels called for — (Houston Chronicle)

SSRI Ed note: Non-profit group petitions the State Dept of Health to add warnings about suicide and aggression to Prozac labels.

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Houston Chronicle

January 11, 1994

Author: MARK SMITH; Staff

DALLAS — Texas’ largest mental health consumer organization has petitioned the Texas Department of Health to require a “suicide and aggressive behavior” warning on prescription bottles of Prozac, one of the nation’s most widely prescribed anti-depressants

Texas Mental Health Consumers, a nonprofit advocacy group, and the Austin-based group, Stop Therapy Abuse, said Monday they plan to expand their call for warnings to be placed on other similar drugs.

“You shouldn’t have to play Russian roulette with medications,” said Cindy Hopkins, executive director of Texas Mental Health Consumers.

“These medications may have many adverse reactions that individuals are not warned about by their doctor or by the labeling on the bottle.”

Hopkins said she found it surprising that consumers are warned about possible side effects on other medications — including possible sun burns from sensitive skin caused by use of sulfa drugs — but not powerful psychoactive drugs.

The U.S. Food and Drug Administration has received thousands of complaints from doctors and patients, according to Hopkins. Studies published by physicians in the The New England Journal of Medicine and The American Journal of Psychiatry also have warned of possible side effects, including thoughts of suicide.

Others calling Monday for warning labels included two former Prozac users from Houston.

Shannon Porter, 17, a high school junior, and Marcy Butler, 45, alleged that Prozac had caused them to weight, have bad dreams and suffer wide mood swings. Both said they attempted suicide, and they believe the drug contributed to the decision to kill themselves.

“I had tried to commit suicide once, seven years before taking Prozac,” Porter said. “But after Prozac, suicide became an obsession. I could see myself dying.”

Porter, who no longer takes any medications, said she has excelled in school after discontinuing use of the drug, garnering honors in a leadership camp and literature group.

“I know more and more kids are being given Prozac, and I know that they are not being warned of what can happen to them,” Porter said. “I would actually like to get Prozac banned, but I think a warning would be a good first step.”

Butler said her treating physician failed to warn her of any side effects. But soon after she took the drug, Butler said she suffered blurred vision, slurred speech and hot flashes in which she believed her body temperature had jumped.

“When I informed my doctor of this, I was informed that I had to keep taking Prozac until my body got used to it,” Butler said. “After taking it for one month, I decided one night for no reason to slit my wrist.”

Officials with Prozac’s Indiana-based manufacturer, Eli Lilly & Co., said their product is safe, having been prescribed to 6 million patients in the United States.

“It’s the disease, not the medicine, that causes the problem,” said Ed West, an Eli Lilly spokesman. “It’s understandable that a grieving family member would seek to fix blame to some external cause. But the cause of the disease is depression, not the medications that are saving their lives.”

West said his company has refused to comment on the number of adverse reactions linked to Prozac, but claimed some 3,000 scientific papers substantiate the company’s claims that Prozac is “safe and in fact helps people who have suicide ideation.”

“Every product has adverse reactions,” West said.  However, he said the the U.S. Food and Drug Administration’s advisory committee unanimously voted in 1991 to reject a similar proposal to place a warning label on Prozac prescription bottles.

“It’s an old issue and had been exposed as a hoax three years ago,” West said

Dateline:  DALLAS
Record Number:  HSC01111176879