March 5, 2011
For years, prescription cold and cough medicines like Cardec, Rondec, Organidin, Pediahist, and hundreds of other drugs have been available to patients, even though none of them have ever received approval from the US Food and Drug Administration (FDA). The FDA recently decided to crack down on the unapproved stray drugs, ordering 500 of them to be pulled from the market.
“We have serious concerns about them because we just simply don’t know what is in them, whether they work properly or how they are made,” said Michael Levy, director of the FDA’s Division of New Drugs and Labeling Compliance, in a statement.
Many of the drugs involved in the culling have been available since before the FDA even had an approval system, which is why they continue to be sold at many drug stores. But the agency also says it does not know how many of the drugs are even still available or being sold, since many people have since switched to similar FDA-approved products that are available without a prescription.
The FDA says the pull was also instigated by various drug complications that have been reported via the agency’s adverse event reporting system. But the main goal of the effort is to bring all unapproved drugs into FDA compliance by pushing their manufacturers to undergo the agency’s multimillion dollar approval process.
However, the FDA does not seem all that concerned about the drugs it has approved that are quite popular in the adverse event department. Serious complications from the human pappillomavirus (HPV) vaccine Gardasil, for instance, have received little to no attention from the FDA (http://www.naturalnews.com/Gardasil…).
Manufacturers have 90 days to stop producing the unapproved drugs and 180 days to stop shipping them.
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This article was posted: Saturday, March 5, 2011 at 3:26 am