Magazine article Drug Topics

Pharmacists to FDA: Give Flexeril Switch the Red Light

Magazine article Drug Topics

Pharmacists to FDA: Give Flexeril Switch the Red Light

Article excerpt

The Food & Drug Administration's Nonprescription Drugs Advisory Committee and its Arthritis Advisory Committee are considering whether to give Merck & Co. the green light to switch Flexeril 5 mg (cyclobenzaprine) to over-the-counter status. Drug Topics, in the magazine and on its Web site, asked pharmacists to consider the same question: Should Flexeril go OTC? Overwhelmingly, they said No.

Among the reasons pharmacists gave for giving OTC Flexeril the thumbs-down were the potential for side effects and interactions, adult and teenage abuse, and overdose.

James G. Campbell, R.Ph. at CVS in Terre Haute, Ind., who has been a pharmacist for 30 years, said he was opposed to one of the first switches-hydrocortisone 0.5%because he was afraid that parents would use it on diaper rashes. He is now concerned about Flexeril's side effects and interactions. "Flexeril is related to the tricyclics, which could and would cause many problems when combined with just about everything," he told Drug Topics.

Campbell said that he receives many requests for OTC muscle relaxants and wouldn't feel very comfortable suggesting OTC Flexeril without a thorough patient history. He would also want to know the patient's potential for abuse. "Call me old-fashioned, but I am not ready for this one," he said.

Michael Abbott is another pharmacist who is opposed to Flexeril being sold OTC. "I have seen more patients with CNS side effects [from Flexeril] than from many other prescription medications that have similar warnings," he observed. Abbott said he knew a patient who took Flexeril while driving. He drove to a different location from the one intended and wasn't sure how he had gotten there. Patients have described Flexeril as a drug that "really knocks me out," said Abbott, who believes ease of purchase might allow kids to use the product to get high.

Randy R. Skirvin, D.Ph., San Diego, said that Flexeril is too strong a CNS depressant to be allowed to switch to OTC. "About one-third of my patients tell me that after taking a single dose, they are no more than a couch potato. This drug interacts with too many others to even be considered for OTC status," said Skirvin.

Nicole Bergmann, senior CPhT, Walgreens, Milwaukee, said, "Flexeril has no business as an OTC drug. We really need to think about the people out there who would be able to get this drug. …

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