February 01, 2006
FDA calls for black-box warning for Bayer stroke drug
The FDA has asked Bayer to add a black-box warning to its stroke drug Nimotop (nimodipine), directing doctors to administer the drug orally.
Nimotop is approved to treat subarachnoid hemorrhage, a type of bleeding in the brain that is believed to cause up to 10 percent of all strokes.
The agency said it received reports of healthcare professionals incorrectly administering the drug by injection or intravenously, instead of orally, making the effect of the drug much stronger, “leading to cardiovascular collapse and possibly to death.”
The FDA said it received a report of a death possibly linked to incorrect administration of Nimotop in 2005. In addition to the 2005 case, there has been a history of “these errors,” the agency said in a posting on its Web site. Two cases were reported in 1995. Another case, which resulted in death, was reported in 1996. And additional non-fatal cases were reported in 1999, and in 2002 (two cases in total).
After the 1996 case, the manufacturer, Bayer, included a bolded statement in the labeling, warning against incorrect administration.
According to published reports, Bayer said it will add the black-box warning to Nimotop and will work to inform healthcare professionals about the change.