FDA CITES RELIANT FOR HEART DRUG PROMOTION

Reliant Pharmaceuticals failed to disclose any risk information in two promotional pieces for its Rythmol SR extended-release capsules and suggested that the product is effective for more indications than those approved by the FDA, the agency said in a warning letter to the company. Thus, the pieces are "false or misleading" and amount to "misbranding" the drug, the warning letter said.

The warning letter, issued Sept. 14 and posted to the FDA website Sept. 15, said that the promotional pieces are misleading because they make numerous claims about the use of Rythmol SR in treating atrial fibrillation, but do not include information on risks associated with the drug. "By omitting the most serious and frequently occurring risks associated with the drug, these pieces misleadingly suggest that Rythmol SR is safer than has been demonstrated by substantial evidence or substantial clinical experience."

Moreover, the warning letter said, "these pieces contain numerous representations that promote the use of Rythmol SR to treat the broad population of patients with 'atrial fibrillation,' or 'Afib'," even though the product labeling identifies limitations on this use of the drug.

"We have received the FDA's letter and are preparing our response," Marylou Rowe, a spokeswoman for Reliant, said.

The text of the warning letter can be accessed at www.fda.gov/cder/warn/2006/Rythmol_wl.pdf (http://www.fda.gov/cder/warn/2006/Rythmol_wl.pdf).