A British medical journal said Friday it had given U.S. regulators confidential drug company documents suggesting a link between the popular antidepressant Prozac and a heightened risk of suicide attempts and violence.
The British Medical Journal reported in its Jan. 1 issue that documents it received from an anonymous source indicated that Prozac's manufacturer, Eli Lilly & Co., was aware in the 1980s that the drug could have potentially troubling side effects.
The report comes at a time of renewed scrutiny of the pharmaceutical industry and the government's process for approving drugs. Studies of the painkillers Celebrex, Aleve and Vioxx have recently indicated those drugs may increase some health risks.
The Journal said the documents, reportedly missing for a decade, had formed part of a 1994 lawsuit against Eli Lilly on behalf of victims of a workplace shooting in Louisville, Ky. Joseph Wesbecker, the gunman who killed eight people and himself in 1989, had been prescribed Prozac a month before the shootings.
Eli Lilly won the case, but later disclosed it had settled with the plaintiffs during the trial.
The Journal said a record dated November 1988 reported that fluoxetine, the generic name for Prozac, had caused "behavioral disturbances" in clinical trials.
A Food and Drug Administration spokeswoman, Kathleen Quinn, could not confirm Friday whether the agency had received the documents. But at least one member of Congress said he had obtained copies of the documents reportedly given to the FDA.
In a written response, Eli Lilly said, "To our knowledge, there has never been any allegation of missing documents" from lawsuits involving Lilly. The company also said it tried unsuccessfully to obtain copies of the documents from the Journal.
"Lilly has consistently provided regulatory agencies worldwide with results from both clinical trials and postmarketing surveillance," including data related to Prozac, the statement said.
Eli Lilly's stock fell 75 cents, or 1.3 percent, to $56.75.
It is unclear what, if any, action might result from the matter. In October, the FDA ordered pharmaceutical companies to include "black box" warnings on the labels of their antidepressants, including Prozac. The warnings are the strongest restriction the government can impose on pharmaceutical companies, short of a ban.
The warnings state that antidepressants increase the risk of "suicidal thinking and behavior in children and adolescents."
Even if the documents do not prompt legal or regulatory action, they could sully Eli Lilly's image. The company's fortunes have been closely tied to Prozac.
The company has long defended the drug in the face of legal and medical challenges and insisted that it has not suppressed relevant information about the drug.
Rep. Maurice Hinchey, D-N.Y., a vocal opponent of the government's drug approval process, said Friday that he had some of the documents cited by the Journal article. The congressman, who is a member of the Appropriations Committee, which oversees federal agencies including the FDA, said the documents date back to the 1980s and include memos between Eli Lilly employees.
They "clearly show a link between Prozac and actions of violence perpetrated by people taking the drug against themselves and against others," Hinchey said. "The documents we have show that the company was instructing its employees to hide this information. We're seeing evidence here that it was a conscious act on the part of the company."
Information from the New York Times and the Associated Press was used in this report.
WHAT IT IS: In 1987, Prozac became the first of the selective serotonin reuptake inhibitors to be approved for use in the United States. This new class of drugs is believed to help regulate mood by increasing the availability of serotonin in the brain.
WHO SELLS IT: Eli Lilly and Co. makes Prozac, its brand name for the drug fluoxetine (floo OX e teen). However, many generic equivalents became available after the company's patent ran out in August 2001. Additionally, fluoxetine is sold under the brand name Sarafem to treat women with premenstrual dysphoric disorder.
WHO USES IT: Prozac is used to treat clinical depression, bulimia, obsessive-compulsive disorder and panic disorder. Prozac has been approved and marketed in more than 90 countries and used by more than 40-million people worldwide.
Sources: Eli Lilly and Co., Galen Holdings PLC, Times files