Drug Safety, Recalls and WithdrawalTuesday, May 7, 2013
It may go without saying that you should use discretion when taking anything that is prescribed to you after a work-related illness or injury. Of course all pharmaceuticals must be subject to rigorous testing and analysis before being approved for the market. In general this means making sure that the benefits of a medication outweigh the risks associated with its use. However, many times adverse reactions arise after people have already been prescribed and begin administering a drug.
The Food and Drug Administration has released a guide to safe use of prescription medications that is summarized below.
Before a drug can be tested on people in the United States, extensive preclinical data must be collected and presented to the FDA by any organization involved with its development. This generally entails animal testing. The FDA then analyzes whether or not these tests show the drug to be reasonably safe and effective enough to tests on humans. One of the main concerns during the initial testing phase is the presence or adverse drug reactions, otherwise known as side effects.
Certain medications are required to come with FDA approved guides that detail the risks of the specific drug or drug class that is prescribed. There are also Consumer Medication Information (CMI) sheets. These are generally distributed at pharmacies and are not developed or regulated by the FDA. They contain broader information about a drug that is not included on a CMI sheet such as how to store medication, symptoms of misuse and what to do if you experience serious adverse side effects. Generally the product’s labeling may also include a “black box warning” about serious risks associated with it.
After a drug is approved and on the market, it may still be under scrutiny from the FDA. Extensive Post-Market Surveillance is conducted to make sure there aren’t any problems that did not arise during initial testing. Many issues may also come up that have to do with the manufacture of the drug or improper labeling. Problems reported with prescription medications are compiled in an electronic database called the FDA Adverse Event Reporting System (FAERS). The FDA’s safety and adverse event reporting program is called MedWatch. Their primary goal is to keep consumers and health care professionals informed about any problems that have come up with a variety of medical products and equipment.
If the FDA determines a drug’s use production and distribution a law, it may be recalled. A drug may be recalled due to problems with packaging, manufacturing or contamination as well as generally serious adverse side effects. In rare cases, the FDA may withdraw a drug if it is determined that the products side effects outweigh its benefits.