Medication Recalls
We’ve all heard news stories at some point that proclaim the recall of certain drugs. But what does that mean and should we be concerned? Basically, recalls are protective measures taken by drug manufacturers or the federal government to ensure the safety of those individuals taking a medication that could be potentially dangerous.
The Food and Drug Administration (FDA) is a branch of the United States Department of Health and Human Services. It is responsible for protecting the health of the US public by assuring the safety, effectiveness and security of human and veterinary drugs among other things. To accomplish this end, the FDA requires each new drug that is developed be subjected to extensive laboratory and clinical testing prior to them granting approval. Their Center for Drug Evaluation and Research regulates over the counter drugs (OTC), prescription only medication (POM) and generic drugs. Drug companies must test their drugs in the lab on animal subjects first before moving on to human clinical trials. After thorough testing, the company is eligible to submit an application to the FDA for approval. This application includes the testing results, label and warning information and manufacturing information. Upon the application’s review the FDA can approve the drug if the benefits outweigh the risks.
After a drug has been on the market, the FDA will continue to monitor its progress. Should any new safety concerns arise, it will inform the drug company of the issue and three possible actions can occur: a company can recall the drug on its own initiative, the FDA can request the company to recall the drug, or the FDA can order a recall under statutory authority. The four types of recalls include, Class I, Class II, Class III and Market Withdrawal. Class I recalls define a situation in which the FDA believes there is reasonable probability that exposure to a certain drug could cause serious health problems or even death. Class II recalls are situations where exposure to drugs have a possibility of causing temporary or medically reversible adverse health problems. Class III recall are cases in which use of the drug is unlikely to cause any adverse risks. And finally market withdrawals occur when products have minor violations and the company can remove the medications from the market, correct the problem and reintroduce the product at a later time.
Next time you hear that a drug you are taking has been recalled or withdrawn from the market, contact your physician for more information. Whether it is a major or minor recall, it is always smart to be informed about the medication you take and their risks.
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This entry was posted on Wednesday, February 17th, 2010 at 11:12 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
