FDA Warns Valeant Subsidiary for Hiding Risks in Product Promo Piece

The FDA’s Office of Prescription Drug Promotion warned a Valeant Pharmaceuticals subsidiary for failing to include risk information in promotional material for a cough suppressant.

According to the July 27 letter, the material doesn’t disclose that use of ECR Pharmaceuticals’ TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) carries a number of serious and potentially fatal risks. The material also makes unsubstantiated claims that suggest patients prefer TussiCaps’ capsule dosage form over liquid cough formulations.

ECR’s sales aid also doesn’t provide TussiCaps’ full approved indication, leaving out that it is for adults and children age six and up.

TussiCaps is contraindicated in patients allergic or sensitive to hydrocodone and chlorpheniramine and in children under the age of six due to the risk of fatal respiratory depression. The product labeling also warns of the possibility of acute abdominal conditions and obstructive bowel disease with use of the drug.

None of this information is included in the four-page sales aid, the warning letter says, adding a statement on the last page that appropriate product labeling should accompany the aid doesn’t make up for the omission. Customers are given the impression the drug is safer than has been demonstrated.

The FDA told ECR to stop distributing the material and submit any other materials that make similar omissions and claims.

Valeant spokeswoman Laurie Little says the company stopped using the sales aid about two months after acquiring ECR in June 2014. “Our current promotional materials for TussiCaps contain the appropriate risk information,” she said.

View the warning letter at www.fdanews.com/08-10-15-ECRWarning.pdf. The promotional aid is at www.fdanews.com/08-10-15-TussiCapsSalesAid.pdf. — Kellen Owings