FDA actions

FDA actions

The FDA has issued a warning regarding the potential for arrhythmia associated with the anti-nausea drug ondansetron (Zofran). The drug should be avoided in patients with QT prolongation as they are at particular risk of developing torsade de pointes. Ondansetron should be used with caution in patients with congestive heart failure, bradyarrhythmias, those predisposed to low potassium or magnesium, and in those taking drugs that cause QT prolongation. These patients should have electrocardiogram monitoring if ondansetron is indicated. The FDA is requiring new labeling changes to reflect these warnings.

The FDA is reminding physicians and patients that epinephrine inhaler (Primatene Mist), the only over-the-counter inhaler for asthma, will be removed from the market on December 31. The withdrawal is due to an international ban on chlorofluorocarbon propellant. The FDA is recommending that physicians ask their patients with asthma if they use Primatene Mist and talk to them about prescription alternatives.

The FDA has approved infliximab (Remicade) to treat moderate-to-severe ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy. The drug is already approved for adults with UC. The approval was based on a randomized, open-label trial of 60 children ages 6 to 17 with moderate-to-severe UC. The drug carries a boxed warning for serious infections and cancer. Infliximab is manufactured by Janssen Biotech.