
More than a year after its advisory panel unanimously declared the drug phenylephrine to be useless against nasal congestion, the U.S. Food and Drug Administration is proposing that it be removed from common over-the-counter decongestants. Products that include phenylephrine as an active ingredient include Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion. In fact, “it is important to note that some products only contain oral phenylephrine as a single, active ingredient,” the FDA said in a statement released Thursday. However, based on the available science, it’s time for consumers to stop throwing their money away on such products, the FDA said. “It is the FDA’s role to ensure that drugs are safe and effective,” Dr. Patrizia Cavazzoni, who directs the FDA’s Center for Drug Evaluation and Research (CDER), said in the statement. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.” The agency said its experts poured over decades of data on whether or not phenylephrine could ease nasal congestion. They found no evidence to support the claim, nor any evidence to support the notion that phenylephrine might boost the effects of other medicines included in a decongestant, such as acetaminophen or dextromethorphan. At… read on > read on >