A recent FDA advisory committee report revealed that an active ingredient in several popular cold medications is ineffective, leading CVS to remove them from its inventory.
According to the agency, some oral cough and cold medications with phenylephrine as the sole active component are being removed from CVS Pharmacy locations. More oral cough and cold medications will still be available to satisfy customer demand.
"We are aware of the FDA Advisory Committee’s position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations."- CVS
The FDA Nonprescription Drugs Advisory Committee held a vote in September to determine if phenylephrine, a component in Benadryl Allergy Plus Congestion ULTRATABS and Sudafed PE Sinus Congestion, is a helpful nasal decongestant when taken orally.
The U.S. Food and Drug Administration determined in September that the presence of phenylephrine was no more effective when taken orally than a placebo.
Dayquil, Mucinex Sinus-Max, Sudafed PE Sinus Congestion, Theraflu, and other well-known cold products available at pharmacies around the country, including oral phenylephrine.
During a meeting last month, a panel of advisors deliberated over the potential withdrawal of phenylephrine products from the market and voted "no" on the effectiveness of oral phenylephrine.
Maryann Amirshahi, a committee member, stated that if the products were taken off the market, the focus should be on their removal due to efficacy concerns rather than safety issues..
The agency concluded: "FDA remains committed to using all available tools to assure the safety and efficacy of FDA-regulated drug products and to help ensure that Americans have access to medicines that are safe and effective for their labeled uses."
- FDA. FDA clarifies results of recent advisory committee meeting on oral phenylephrine.
- NDAC Briefing Document. FDA Briefing.