An article in a medical journal today suggested that drugmaker Eli Lilly & Co. had long concealed evidence that its well-known antidepressant, Prozac, could cause violent and suicidal behavior.
The accusations were made in the Jan. 1 issue of The British Medical Journal, which said it had turned over documents related to the allegations to the U.S. Food and Drug Administration.
The FDA was reviewing the papers, which had been missing for more than 10 years, according to the Journal article, which said they were originally gathered during a lawsuit against Eli Lilly & Co. on behalf of victims of a gunman in Kentucky who reportedly had been taking Prozac for a month before going on a rampage.
An FDA spokeswoman, Kathleen Quinn, could not confirm yesterday whether the agency had received the documents mentioned in the medical journal. But at least one member of Congress said he had obtained copies of the documents reportedly given to the FDA.
In a written response, Lilly said: "To our knowledge, there has never been any allegation of missing documents" from lawsuits involving Lilly. The Indianapolis 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 post-marketing surveillance," including data related to Prozac, the company said.
Eli Lilly's stock fell 75 cents, or 1.3 percent, to $56.75 yesterday.
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 banning a drug.
The warnings state that antidepressants increase the risk of "suicidal thinking and behavior in children and adolescents."
British medical regulators have recommended that many antidepressants not be prescribed for children and teenagers, but had not included Prozac in those advisories.