The maker of the acne medication Accutane ignored a company doctor's recommendation that people who take the controversial drug be monitored for signs of depression and that a warning to that effect be added to the drug's U.S. label, USA Today reported Tuesday.
The newspaper cited allegations in a Florida-based federal court case against the drug company, Hoffman-La Roche, charging that the Swiss pharmaceutical giant didn't include the warning because it could affect sales or prompt lawsuits.
The doctor's recommendation and the marketing debate outlined in legal filings have not been previously publicized, according to USA Today.
Accutane has not been officially linked to depression or other mental illnesses and Roche claims the drug is effective when used properly.
But the newspaper reported that a senior Roche official, testifying in a pretrial deposition for the Florida case, said the firm's internal analysis indicated that some patients who were prescribed Accutane probably suffered depression and other mental illnesses as a result of taking the drug, according to a summary in a court brief.
Tightened restrictions
The report follows recent charges from U.S. Food and Drug Administration researcher David Graham that Accutane was one of at least five other drugs on the market today that should be investigated because of safety concerns.
Graham commented on Accutane while testifying before a congressional committee about the FDA's oversight of the now-banned arthritis drug Vioxx.
The alleged internal corporate debate over an Accutane warning emerged from a USA Today review of Accutane lawsuits.
Since Graham's testimony before the U.S. Congress, the FDA has tighten warnings to doctors who prescribe Accutane or generic equivalents of the drug chemically known as isotretinoin. Patients who take it will now be registered in a database because of government rules for drugs linked to birth defects.
Fetal death and birth defects in children whose mothers took the drug while pregnant are major side effects of Accutane and its generics. As part of the stricter regulations, women of childbearing age will be required to provide proof of a negative pregnancy test before being prescribed the drug.
Accutane, which is derived from vitamin A, was launched in the United States in 1982 as a way to control severe acne.