FDA Takes Action on Unapproved Prescription Drugs That Contain Hydrocodone
200 Cough Suppressants to Be Impacted
Hydrocodone is a medication that treats pain or suppresses coughs. The drug is widely known to cause serious illness, injury, or death if used improperly and is also known for it's popular use for drugs abusers. An overdose of hydrocodone can cause cardiac arrest, as well as impairing your motor skills and judgment.
This new enforcement by the Food and Drug Administration came about after numerous reports of medication errors that had been associated with the formulation changes in the unapproved hydrocodone products. The reports have shown that the errors are associated with the confusion of similarities between those drugs that have been approved, and those unapproved.
There are some hydrocodone products that are approved by the FDA such as Vicodin, however most of the products that contain hydrocodone that are marketed to suppress coughs are not approved. This worries the agency regarding the proper pediatric labeling of those hydrocodone cough suppressants that are not approved due to the risk of medication error.
The FDA has announced that anyone who is marketing or distributing and of the unapproved hydrocodone products that are currently for children under six years-old must halt the manufacturing as well as the distribution by October 31, 2007. It has also been announced that those who are marketing and distributing any other unapproved hydrocodone products must stop manufacturing by December 31,2007. If companies fail to comply with these terms, the FDA will seek further legal action.
The Director of the Center for Drug Evaluation and Research, Deborah M. Autor, J.D., says "This is another example of the kinds of safety risks that warrant priority enforcement under our Compliance Policy Guide," she also goes on to add, "There are products on the market with inadequate safety information on their labeling improperly suggesting that the products may be used safely by very young children. In addition, these products may pose a higher risk of medication error than approved products. These products need to come off the market until they meet FDA approval standards."
Those who are taking the unapproved products with hydrocodone should know that there are other medications that are FDA approved that do contain hydrocodone in them. At this time there are seven products that are FDA approved which contain hydrocodone. There are also many different varieties of FDA approved antitussive products that do not contain hydrocodone. Those who are not sure should consult their physician immediately before taking any other medication or those that are not FDA approved.
Those who would like to learn more about specific products that contain hydrocodone can go to Hydrocodone Drug Products Information and learn more.
SOURCE : FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01713.html
Published by Jeanne Marie Kerns
My passion is writing. Helping those in need get their message out is something I strive for. I love to interview those who do not feel that what they have to say is not being heard. My hand is the extension... View profile
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