CVS has decided to remove cold medicines from its shelves that contain a decongestant which a Food and Drug Administration (FDA) panel has deemed ineffective. This decision by CVS is voluntary, as the FDA panel’s findings are not legally binding. Oral medicines that solely contain phenylephrine as an active ingredient will be taken off the shelves, according to a spokesperson from CVS.
Competitor Walgreens, on the other hand, is waiting for further guidance from the FDA before making a decision on products containing phenylephrine.
While the FDA panel states that phenylephrine products are safe, they also found that these products do not provide relief from congestion caused by colds and other illnesses. However, it’s worth noting that this finding does not apply to nasal sprays containing phenylephrine.
The FDA has not issued a recall for drugs containing phenylephrine, but their panel’s findings open the path for the agency to remove phenylephrine from the list of approved ingredients. If this process is carried out, products containing phenylephrine will no longer be legal for sale in the U.S.
It is important to mention that industry groups disagree with the FDA panel’s findings, stating that there have been numerous clinical trials and previous regulatory determinations that affirm phenylephrine’s effectiveness as a decongestant at its labeled dose.
