Unapproved Hydrocodone Cough Suppressants Ordered Off Market
FDA Action is Latest Effort To Combat Unapproved DrugsOct 1, 2007 | Parker Waichman LLP
On Friday, the Food & Drug Administration (FDA) announced that it was cracking down on unapproved hydrocodone cough suppressants, ordering the manufacturers of these drugs to stop making most of them by the end of the year. The FDA announcement was the latest action in the agency’s ongoing efforts against dangerous unapproved drugs.
Hydrocodone, a powerful narcotic, is used in some prescription painkillers and cough suppressants. According to the FDA, hydrocodone is an ingredient in more than 200 prescription cough suppressants, but only a handful of these medications are approved. The 9 approved hydrocodone-containing cough suppressants currently on the market are: TussiCaps; Tussionex Pennkinetic; Hydrocodone Compound; Mycodone Homatropine Methylbromide; Hycodan; Tussigon; and Vicodin.
Hydrocodone is highly addictive and if not used properly, can cause serious injury and death. People who overdose on hydrocodone can experience breathing problems or cardiac arrest and it can impair motor skills and judgment.
Many unapproved hydrocodone cough suppressants are improperly labeled, and have names similar to approved versions. The FDA said that it had received reports of medication errors associated with unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drugs. The FDA also said that it was concerned about unapproved hydrocodone products labeled for use in children. Hydrocodone is not approved by the FDA for use in children under two, but many unapproved hydrocodone cough suppressants are labeled as being suitable for very young children.
The FDA ordered companies making unapproved hydrocodone drug products to stop manufacturing such products on or before December, 31, 2007, and to "cease further shipment in interstate commerce on or before March 31, 2008." The FDA also took action against hydrocodone cough suppressants marketed for young children. The FDA ordered companies marketing unapproved hydrocodone products that are labeled for use in children younger than 6 years of age to stop manufacturing and distributing the products by October 31, 2007.
The FDA move against unapproved hydrocodone cough suppressants is part of the agency’s efforts to crack down on unapproved prescription drugs. According to the FDA, around 2% of the medications on the market have not been granted FDA approval. Some of these unapproved drugs were on the market prior to 1962, when federal laws were changed to require drug manufacturers to seek approval for their products from the FDA. Although it is illegal to market unapproved drugs, the FDA did not begin taking action against such medications until recently. While the FDA has said that it does not have the resources to go after all unapproved medications, it will be taking steps to force the most dangerous unapproved drugs off of the market.