FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products

The U.S. Food and Drug Administration has issued a strong warning to any company that is selling unapproved prescription drugs that have hydrocodone and have not been approved. Hydrocodone is a narcotic in wide use for treating pain and suppressing coughs. The FDA says they will talk legal enforcement actions. This will not apply to any companies that have FDA approval.

Hydeocodone is very strong, one of the strongest in fact. And for that reason, it is also very popular with drug abusers. If it is not used properly, Hydrocodone can cause illness, injury, or death. Some of the effects are breathing problems, cardiac arrest, impaired motor skills and impaired judgement.

Is its statement, the FDA states that they have received many reports of medication errors that are associated with the changes in the formula in the unapproved hydrocodone products. There is also a lot of confusion over the similarity in the names of unapproved products to approved drug products. When a drug is approved, the FDA takes into consideration any possible medication errors and name confusion.

The way the situation is now, most of the products, especially the ones to suppress coughs, are not approved. One that has gotten approved by the FDA is Vicodin. One of the things that the agency is most concerned about is the improper pediatric labeling of unapproved hydrocodone cough suppressants. These are known as antitussives. One important thing to note is that there are absolutely no hydrocodone cough suppressant that is considered safe for children under the age of 6. Some of the unapproved cough medications have labels with dosing instructions for children as young as 2.

There are many different options for patients who might be using the unapproved drugs. First of all, there are a total of seven of the hydrocodone drugs that have been approved by the FDA. And there are other products that do not contain hydrocodone at all.

The statement that the FDA released today states that anyone who is marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age are being ordered to manufacturing and distribution of the products on or before October 31, 2007.

Those that are marketing any other unapproved hydrocodone drugs are ordered to stop manufacturing such products on or before December 31, 2007. They must also stop shipping in interstate commerce on or before March 31, 2008. If these deadlines are not met, the FDA will be taking further legal action. Of course, the companies do have the option of having their products tested and approved by the FDA.

Source: FDA http://www.fda.gov/