Wednesday, August 23, 2006
Prescription Drugs

Rep. Waxman Requests Investigation of Effectiveness of Phenylephrine Nasal Decongestants

Rep. Waxman asks FDA to investigate whether phenylephrine oral nasal decongestants are effective. In response to provisions in the 2006 reauthorization of the Patriot Act requiring that pseudoephedrine products be moved behind the counter, manufacturers have begun to offer alternative oral nasal decongestants that eliminate pseudoephedrine and rely instead on phenylephrine, which permits them to be sold over-the-counter without any restrictions. Medical studies indicate that phenylephrine may be no more effective than placebo in alleviating nasal congestion, raising questions regarding FDA’s conclusion that the drug is safe and effective for over-the-counter use.