Physicians may be unknowingly prescribing cough suppressants that have not been approved by the US Food and Drug Administration (FDA), some of which may be unsafe for young children.
To address this situation, the agency is taking measures to stop the marketing of unapproved medicines containing hydrocodone, a semisynthetic opioid that acts as an analgesic and as an antitussive (cough suppressant). The main focus of the FDA's action, which the agency announced on September 28, centers on antitussive hydrocodone products, of which only 7 of approximately 200 are approved.
Mitka M. FDA Bans Sale of Unapproved Cough Suppressants Containing Hydrocodone. JAMA. 2007;298(19):2251–2252. doi:10.1001/jama.298.19.2251