Monday, October 23, 2006
Prescription Drugs

Based on Claritin-D Advertisement, Rep. Waxman Renews Request That FDA Investigate Phenylephrine Oral Nasal Decongestants

Citing a new Claritin-D advertisement, Rep. Waxman renews his request that the FDA investigate whether phenylephrine oral nasal decongestants are effective. In the ad, Schering-Plough announced that it will not reformulate Claritin-D, a pseudoephedrine-based oral nasal decongestant, to switch to phenylephrine. Provisions in the 2006 reauthorization of the Patriot Act require that pseudoephedrine products be moved behind the counter, so Claritin-D will not be able to be sold over-the counter. Therefore, Schering’s decision not to reformulate Clairitin-D strongly suggests that a study of phenylephrine’s effectiveness that the company conducted and completed in 2006 may have raised significant questions about the effectiveness of phenylephrine.