Why are pharmaceutical drugs recalled?
The Food and Drug Administration takes great care to test medicines before they are made available to you, as a consumer. However, situations do arise that require the removal of a product from the marketplace. In Georgia, as well as in the rest of the country, swift action is essential to prevent you from suffering from the side effects or from being harmed in some way by compromised or otherwise dangerous drugs. Once a drug is available to consumers, what, exactly, is the criteria for taking that drug off the shelves?
A primary reason for a recall is that the drug poses a danger to your health. This result is not always predictable before the drug goes to market. For example, some decongestant medications that contained the drug phenylpropanolamine (PPA) were removed from stores in 2000 when it was shown that PPA could make you susceptible to hemorrhagic stroke.
The National Center for Biotechnology Information states that a recall may occur when a drug prescribed to you and to others is found to be contaminated, either during the drug’s production or during its distribution. Sub-standard manufacturing practices may also be to blame. Often a manufacturer or the FDA will initiate a prescription drug recall when the label offers incorrect dosing instructions. Lastly, a drug may be recalled because it is simply not what the label or the packaging says it is.
Prescription drug recalls fall under a number of different categories. They include:
- Class I: Use of the product could result in severely compromised health or death.
- Class II: Negative consequences from use of the drug are possible, but remote.
- Class III: You are not likely to suffer adverse health effects from use of the drug.
- Market withdrawal: This can occur when a company voluntarily removes a product that exhibits a minor violation of FDA rules. You may be able to find this product on the market again once the issue is fixed.
The NCBI reports that company compliance with FDA regulations is an ongoing issue, and a reason why you may see so many drugs are recalled. The Center states that the lengthy list of recalls for pharmaceutical drugs on the FDA website shows you that companies are dismissing federal standards in their haste to get drugs to market and into your medicine cabinet.