Concordia Chided by FDA Over Its ADHD Drug’s Misleading Sales Pitch

The FDA admonished Concordia Pharmaceuticals for a telephone sales pitch about its attention deficit hyperactivity disorder drug Kapvay that omits critical risk and dosing information.

The telemarketing script the Canadian drugmaker used to promote Kapvay (clonidine hydrochloride) to healthcare providers failed to mention important risk information about the drug, including that it shouldn’t be prescribed for patients hypersensitive to clonidine. It also doesn’t mention warnings, precautions and adverse events connected with the drug, says the untitled letter released by the FDA’s Office of Prescription Drug Promotion (OPDP).

The script does direct professionals to the company’s website for the full prescribing information about Kapvay, which is an ADHD monotherapy and an adjunctive therapy to stimulant medications. Telephone sales people also asked prescribers if they wanted to receive full prescribing information via e-mail. However, OPDP said this wasn’t enough to make up for the omissions.

Dosing information was also misleading, OPDP said. The telephone script says doses should be taken twice a day, with either an equal or higher split dosage given at bedtime, says the July 7 letter. However, Kapvay should be taken only once a day with one 0.1 mg tablet at bedtime, and the daily dosage should be adjusted in increments of 0.1 mg a day at weekly intervals until the desired result is seen, according to the prescribing information.

In addition, Concordia failed to include the active ingredient for Kapvay, which is required under federal regulations.

OPDP says Concordia should stop using the script. The drugmaker did not return a request for comment as of press time. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.