The FDA issued a warning that Serono's multiple sclerosis drug Novantrone raised the risk of heart damage. A boxed warning has been added to the drug's packaging, and the Swiss company has advised patients to be tested for heart disease before dosing. Patients taking Novantrone can experience congestive heart failure during therapy or even years after therapy is completed. The drug was approved by the FDA in 2000. In recent months the agency has raised a number of drug alerts as it responds to criticism that it ignored earlier signs of unsafe drugs.
- read this story from Dow Jones for more on the warning