Sudafed - Switch To Phenylephrine

Switch To Phenylephrine

In late 2004, Pfizer publicly disclosed its plans to make available a new over-the-counter product, Sudafed PE, which does not include pseudoephedrine. Decongestants with other ingredients were completely converted to phenylephrine later in 2005. Original Sudafed is still offered behind the counter to customers 18 years of age or older upon request, requiring the customer to show ID and sign a sales log next to a record of their name and address.

The new product was prompted by existing and proposed restrictions on the availability of pseudoephedrine-based products. U.S. state laws imposing such restrictions were in response to pseudoephedrine's role as an ingredient used to synthesize the stimulant methamphetamine.

Pfizer and its predecessor Warner-Lambert had studied at least two alternatives to the pseudoephedrine-containing formula in anticipation of pressure from state regulators and the Food and Drug Administration:

• In 1996, the company began testing a patented decongestant ingredient known as "minus" pseudoephedrine. The company claimed animal tests showed this altered version offered sinus relief comparable to the current "plus" pseudoephedrine. The difference was that it couldn't be converted to methamphetamine, a prescription only drug used recreationally. Pfizer did not bring the new ingredient to market because of the cost and time involved in gaining regulatory approval.
• Pfizer spent US$12 million trying to develop additives for Sudafed that might make it harder to remove the pseudoephedrine it contains. They abandoned the project in 2003, seven years after announcing its existence.

Several pharmacists have questioned the effectiveness of orally-administered phenylephrine as a nasal decongestant. At least one meta-analysis has concluded that it is more effective than placebos, while other research has not found sufficient evidence to support this claim.