The United States Food and Drug Administration (FDA) is responsible for determining what warnings drug manufacturers are required to put on the drugs they produce. After the serious pharmaceutical error involving the meningitis outbreak caused by contaminated steroid injections, the FDA is considering requiring more stringent warning labels for the drugs. Such warnings could possibly prevent future injuries and deaths. However, it looks like the FDA will probably not opt for harsher labels, leaving essentially what was the status quo at the time of the meningitis outbreak in place for the foreseeable future.
Panel Rejects Strict Warnings
The New York Times reports that an FDA advisory panel decided Tuesday not to recommend using the sternest federal warning label on steroid injections intended to treat neck and back pain. These panels are typically made up of groups of medical experts. The group makes recommendations to the FDA about what actions it should or should not take on issues like labeling. The recommendations are in no way binding. However, the agency usually follows these recommendations.
In this situation, the FDA asked the advisory panel whether it should require the injection’s manufacturers to put a label on them called a contraindication. Contraindications basically tell doctors that the risks of a particular medication outweigh any possible benefit. While the overwhelming majority of the advisory panel (fifteen of its twenty-two members) voted that there are in fact clinical situations where the risks outweigh the benefits of these injections, they determined that this was not true in every use of the drug. While one particular use of the drugs that involves injections in the neck close to a certain cluster of nerves caused the experts the most concern, that is only type of procedure these drugs are used for in practice.
One voice of dissent is Dr. William Landau, a neurology professor at Washington University in St. Louis. He argues that there is little scientific evidence that shows that the injections actually reduce pain, and that instead the injections are just a profitable practice for physicians.
How Common is Steroid Injection Treatment?
The use of these steroid injections to treat back and neck pain is quite common. At least one million patients in the United States receive epidural steroid injections each year. Some experts say the number may be as high as 4-6 million patients per year.
How Many Patients Were Injured by the Related Meningitis Outbreak
The Centers for Disease Control and Prevention (CDC) kept track of statistics relating to the meningitis outbreak caused by contaminated injections back in 2012. According to that agency’s numbers a total of 751 patients in twenty states were affected by the outbreak. Sixty-four patients died. All of those patients received preservative-free MPA steroid injections from the New England Compounding Center in Framingham, Massachusetts. Most of the injections were contaminated with a fungus called exserohilum rostratum, which causes a type of meningitis.
See Related Posts: