What effect will FDA’s action have on people who use products that contain hydrocodone?
Are there alternatives? Today’s action will have the most impact on consumers who use unapproved cough suppressant products that contain hydrocodone. It appears that the many currently-marketed hydrocodone pain relief products (e.g., Vicodin) that are listed with the agency have FDA-approved applications. Most of the hydrocodone cough suppressants on the market, however, lack FDA approval. There are seven FDA approvals for cough suppressant products containing hydrocodone (see attachment), including both tablet and syrup dosage forms. There are also a number of antitussive products, both prescription and OTC, that do not contain hydrocodone. Consumers should consult a healthcare professional for detailed guidance on the treatment options that are right for them. 5. Is it safe to use the unapproved products? The safety of unapproved drugs is unknown. There are reports of adverse drug experiences specifically involving unapproved hydrocodone products. In particular, there are a number of
