FDA calls Novartis promotional magnet 'misleading'

The Food and Drug Administration has asked the company to stop using the magnet to promote its drug Trileptal.

The front of the magnet features two claims, with different benefits displayed depending on the angle of the viewer. FDA said information about the drug's risks is printed on the back, where no one sees it if the magnet is stuck to a surface.

"The piece misleadingly suggests that Trileptal is safer and more effective than has been demonstrated," FDA states in the May 1 letter, which it posted to its Web site Tuesday.

Calls placed to Novartis were not immediately returned.

Drug companies are required to include risk information along with a drug's full prescribing information on promotional materials.

Side effects seen with Trileptal include dizziness, vomiting, fatigue and skin reactions. The drug is used to help control certain kinds of seizures and works by decreasing abnormal excitement in the brain.

Sales of Trileptal fell 9 percent last year to $692 million as the drug began competing with lower-priced generic versions. Sales are expected to fall lower this year as more patients switch to generics.

FDA asked the company to respond to its letter by Friday and provide a plan to correct the problems with the magnet.

The FDA issues warning letters to companies that do not follow regulations for manufacturing and marketing of medical products. The letters are not legally binding, but the agency can take companies to court if the warnings are ignored.