FDA yanks 500 unapproved cold and allergy meds

The FDA continues its campaign against unapproved drugs by ordering companies to stop selling about 500 prescription remedies for cough, cold and allergies. The move mostly affects small drugmakers and products first marketed before 1962, when the FDA was charged with reviewing drug safety and effectiveness.

"We don't know what's in them, whether they work properly or how they are made," FDA drug compliance director Deborah Autor said in a telephone news conference (as quoted by the New York Times).

It's just the latest in a crackdown against never-reviewed products: Worried about safety, the FDA started taking action against unapproved drugs in 2006, Dow Jones reports. That year it ordered drugmakers to stop producing drugs containing the antihistamine carbinoxamine. Since then, the FDA has moved to pull unapproved meds 17 times.

The latest order affects drugs such as Cardec, Rondec, PediaHist DM and Organidin, the FDA says. It doesn't apply to FDA-approved products for cold and allergies, such as UCB's Tussionex and Merck's Clarinex.

- see the Dow Jones story
- read the NYT coverage

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.