The Food and Drug Administration warned Johnson & Johnson unit Janssen Pharmaceutica that a letter sent to doctors about its Risperdal drug to treat schizophrenia and bipolar mania is misleading.
In a warning disclosed Tuesday, the FDA told Janssen that its November letter failed to disclose information added to Risperdal’s labeling about excess blood sugar and diabetes and minimized the risk of serious events including coma and even death.
The FDA also said the letter fails to recommend regular testing for diabetes and “misleadingly claims that Risperdal is safer than other atypical antipsychotics.”
The FDA told Janssen to stop distribution of any promotions that contain similar messages, and to disseminate “accurate and complete information” to those who received the misleading information.
Janssen spokeswoman Carol Goodrich said the company was working with the FDA “to address their concerns as quickly as possible.”
“We take the FDA’s letter very seriously,” she said.
Risperdal has been on the market for schizophrenia since 1993 and in December received U.S. approval for the short-term treatment of the manic phase of bipolar disease.
The drug’s worldwide sales were $2.5 billion in 2003.
In January, Janssen said it had received a subpoena from the the U.S. government requesting documents related to Risperdal. The Office of Personnel Management’s inspector general’s office sought documents related to payments to physicians in connection with the sales and marketing of, and clinical trials for, Risperdal from 1997 to 2002, according to Johnson & Johnson’s annual report filed last month.
The FDA sends dozens of warning letters each year. In most cases, the issues raised are resolved without further regulatory action. If the violations cited are not corrected, the FDA can seek a seizure, injunction or other penalty.
The FDA warning letter was dated April 19 and posted on the FDA Web site on Tuesday at http://www.fda.gov/foi/warning-letters/g4628d.htm.