FDA issues “MedWatch Alert” warning on the dangers of epidural steroid injections

There are now about 9 million epidural injections performed annually in the United States and the number of procedures appears to be growing. In 2014, the FDA warned that injection of corticosteroids into the epidural space of the spine may result in rare but serious neurological events, such as “loss of vision, stroke, paralysis and death.” It is critically important that patients carefully select the doctor who will perform the procedure.

Typically, the doctor will first inject into the epidural space a contrast dye to make sure the needle is in the right place. By using x-ray guidance called fluoroscopy, the doctor looks at a screen to make sure the dye is going into the correct location. After this safety step is performed, the corticosteroid and a local anesthetic (lidocaine or bupivacaine) is injected. The majority of studies done conclude that injections make about 50% of patients feel better.

The most common sites for injections are into the cervical (neck) and into the lumbar (back) region. Some patients experience headaches, increased pain, numbness, facial flushing, increased blood pressure or fainting. These are considered minor complications and resolve without treatment in hours or a few days.

Major serious complications include infections, strokes, brain edema (swelling), seizures, blindness and death. We have represented several clients who developed infections such as a spinal abscess. Spinal abscesses may lead to permanent paralysis due to the development of cauda equina syndrome.

The FDA issued a “MedWatch Alert” warning that epidural steroid injections can be extremely dangerous. The FDA is requiring that a warning be placed on the drug label. The FDA has been studying the safety of epidural steroid injections since 2009. Unfortunately, 8 years later, the group’s recommendations are still not ready for release. Although the serious complications are thought to be rare, the lack of reporting of complications and lack of transparency when a serious complication occurs hinder accurate analysis of the frequency of the problem.

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