FDA WARNS COMPANY FOR MISLEADING SAFETY AND EFFICACY CLAIMS

The FDA warned WellSpring Pharmaceutical for a print advertisement the agency said was misleading and overstated the safety and effectiveness of its drug, including using inappropriate studies as supporting evidence.

The print ad for Dyrenium (triamterene) capsules includes unconfirmed efficacy claims and omits risk information, according to the warning letter, which was sent Dec. 12, 2006, and posted last week to the FDA website. These claims make the drug misbranded, the agency said.

According to the letter, Dyrenium is indicated to treat various types of edema. Its approved labeling says the product increases diuresis when patients are resistant to other diuretics.

The advertisement, however, claims that Dyrenium preserves magnesium levels, adding that magnesium deficiencies may increase lipid peroxidation, causing an accelerated growth response in the vessel wall. This statement has nothing to do with Dyrenium's indicated use for edema, the letter said.

The promotional piece also did not include complete risk information for Dyrenium, suggesting the drug is safer than has been demonstrated, the agency said.

WellSpring did not respond to a request for comment by press time.

The warning letter can be viewed at www.fda.gov/cder/warn/2006/Dyrenium-letter.pdf (http://www.fda.gov/cder/warn/2006/Dyrenium-letter.pdf).