CVS is pulling one of the most common nasal decongestants from its shelves nearly a month after advisers to the Food and Drug Administration determined that the active ingredient is ineffective in relieving symptoms.
Products that contain oral medication phenylephrine, a common decongestant in over-the-counter cough medications, pills, and other oral decongestants, will no longer be sold by CVS Health, affecting generic and brand-name products such as NyQuil, Benadryl, Mucinex PE, and Sudafed PE.
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Phenylephrine has been in use as a decongestant since the early 20th century, but the drug became a more commonly used active ingredient in over-the-counter products in the early 2000s, when the Drug Enforcement Agency began to regulate the more effective compound pseudoephedrine more strictly.
Because pseudoephedrine is a common agent used to make methamphetamine, Congress incorporated restrictions on the more effective decongestant in the Patriot Act, requiring patients wishing to purchase the drug to present a photo ID for purchase. Pharmacies must also keep records of who buys pseudoephedrine for a minimum of two years after purchase.
Researchers have called into question the efficacy of phenylephrine since 2007, with studies demonstrating the compound's insufficient efficacy compared to a placebo.
September's advisory panel noted that although oral doses of phenylephrine do not sufficiently constrict blood vessels enough to act as an effective decongestant, nasal sprays of the product sufficiently relieve congestion symptoms.
Although the advisory panel has recommended to the FDA that phenylephrine no longer meets efficacy standards, the administration has not made a final decision on the classification of the drug, nor has it instructed manufacturers or retailers to remove the product from circulation.
A spokesperson for CVS told the Wall Street Journal that the pharmacy chain is aware of the panel's position and will work with the FDA to ensure that it is in compliance with laws and regulations.
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Consumer healthcare groups have noted that they are "disappointed" in the advisory panel's recommendations and have urged the administration not to encourage or force companies to remove phenylephrine from oral medications.
Products containing phenylephrine constitute approximately $1.8 billion in sales annually.