CVS pulling some common decongestants found ineffective
CVS Health will voluntarily remove from its shelves some common decongestants that contain phenylephrine as the only active ingredient, one month after federal drug advisers concluded its oral formulations were ineffective.
The big picture: The decision by one of the nation's largest pharmacy chains is the first major sign of fallout from the recent FDA review of the ingredient.
- The move comes even as the FDA is still weighing whether to order the removal of medications containing phenylephrine, which include products like Sudafed PE and some versions of NyQuil.
CVS will still offer other oral cough and cold products, the company said in a statement.
- "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," the company said.
- Nearly 250 products contain phenylephrine, generating about $1.8 billion in sales last year, according to an FDA presentation last month.
Catch up quick: An advisory panel to the FDA last month backed up findings from the agency's scientists that oral versions of phenylephrine weren't effective, even at high doses.
- Agency scientists said their review of recent rigorous clinical trial data on the ingredient, which has been around since the late 1930s, didn't turn up any safety issues.
- The FDA's review will not affect nasal spray versions of the ingredient.
What's next: The FDA could be months away from taking any action, and any decision to essentially ban the ingredient could face lawsuits.
- The agency does not have to follow the advice of its advisory committees, but it usually does.