CVS is removing cold medicines from its shelves that contain a decongestant which a Food and Drug Administration panel has deemed ineffective. This decision by CVS is voluntary as the FDA’s findings are advisory and not legally binding.
Oral medicines that have phenylephrine as the only active ingredient will be removed, according to a CVS spokesperson. However, competitor Walgreens is awaiting further guidance from the FDA before making a decision on their products containing phenylephrine.
The FDA panel has found that phenylephrine products are safe, but they do not provide relief from congestion caused by colds and other ailments. This finding does not apply to nasal sprays that contain phenylephrine.
The FDA has not recalled drugs containing phenylephrine, but their findings pave the way for the agency to remove phenylephrine from the list of approved ingredients. If this process is completed, products containing phenylephrine will no longer be legal for sale in the U.S.
Industry groups disagree with the panel’s findings, stating that clinical trials and previous regulatory determinations affirm the safety and effectiveness of oral phenylephrine as a decongestant at its labeled dose.
