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Mike Mitka

JAMA. 2007;298(19):2251-2252.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

The US Food and Drug Administration (FDA) is banning the sale of about 200 unapproved antitussive hydrocodone products. Only 7 such products have FDA approval and will remain on the market. (Credit: Molecule Data Source: DrugBank Accession No. APRD00591)

"Most antitussive formulations on the market are unapproved, but the ‘Orange Book’ [the FDA's approved drug products list with therapeutic . . . [Full Text of this Article]