Common painkilling injections resulting in paralysis, death

Valinda Parrish talks to her 60-year-old husband like a doting mother speaks to a child. “I am going to go outside for a little bit,” she tells him. “Use your horn if you need me.”

Rollie Parrish, nearly blind and in a wheelchair, toots the air horn he keeps on his lap if he wants something to eat or has to go to the bathroom. Four years ago, the Vietnam veteran had just spent a weekend deer hunting when he went to a hospital near his home in Nederland, Texas, for a shot of steroids to his neck to ease chronic pain. He suffered a stroke during the procedure, according to a lawsuit that was settled out of court.

“He knows what happened to him, and he is angry,” his wife of 29 years said.

A surge in steroid injections to alleviate back and neck pain in the United States is bringing with it an increase in severe and unexpected complications, including paralysis and death. Reports of the side effects have prompted the Food and Drug Administration to review the safety of steroid injections into the epidural space near the spinal cord, in consultation with an advisory group, the agency confirmed.

“We used to say this is so safe,” said James Rathmell, chief of pain medicine at Massachusetts General Hospital in Boston and a member of the advisory group, who alerted the FDA to cases of such shots causing harsh complications. “It is a very rare event, but it is not zero, and it’s devastating.”

Steroid shots have become the most popular way physicians in the U.S. treat neck and back pain, according to studies. One by Laxmaiah Manchikanti, chairman of the American Society of Interventional Pain Physicians, found the number of such injections to Medicare patients increased 159 percent between 2000 and 2010.

That growth reflects a rise in spending on all treatments for all kinds of pain, a market estimated to be as much as $300 billion a year. Epidurals are one of the interventional procedures — including implants of spinal cord stimulators and shots of pain killers — on which Americans spent $23 billion this year, 231 percent more than in 2002, according to Marketdata Enterprises Inc., a Tampa, Fla.-based company that has tracked the market since 1992. These are distinct from more invasive approaches, such as spinal fusion and disc surgery.

The rise in the injections, according to doctors, is being driven by two events: an aging population prone to back and neck pain and generous reimbursements for treatments.

“The problem with interventional pain is the majority of treatment is medical management,” Rathmell said. “If you pay people to do stuff, they will do more stuff.”

For a typical epidural steroid shot, Medicare pays about $200 if given in a doctor’s office, about $400 if done at a surgery center and about $600 if performed at a hospital.

Some private insurers reimburse more, as much as 150 percent of Medicare rates, according to companies that provide billing services to physicians. The cost of the equipment, supplies and staffing needed for a typical shot can be as low as $120, according to Edgewater, Md.-based Mowles Medical Practice Management.

Known as corticosteroids, the drugs used in the injections have anti-inflammatory powers that make them popular for easing pain in hips, knees, shoulders and other parts of the body, in addition to the back and neck. The FDA review of the epidural shots is being conducted by the agency’s Safe Use Initiative, a unit formed in 2009 to reduce “preventable harm” from medications, said Sandy Walsh, an FDA spokeswoman. She said it was too early to know what action might be taken.

Walsh said the agency is focusing on steroid injections made with the transforaminal approach, which brings a needle within millimeters of critical arteries feeding the spinal cord. It was the method used on Parrish, the lawsuit said.

About half of the 8.9 million epidural steroid shots in the United States last year were administered that way, Manchikanti said.

Another area of concern, according to Rathmell and other physicians advising the FDA, is the use of particulate steroids, a form of the drug that is slow to dissolve and that they said may create blockages that trigger strokes if accidentally shot into arteries.

Particulate steroids include Kenalog from Bristol-Myers Squibb and Depo-Medrol from Pfizer, as well as generic versions of the two.

The labels for both formulations of Kenalog “clearly state they are not indicated for epidural use,” said Ken Dominski, a spokesman for Bristol-Myers, in an email. The Kenalog label says that “reports of serious medical events, including death” have been associated with such shots. Parrish was injected with a mixture that included Kenalog, according to the lawsuit.

A spokeswoman for Pfizer, Joan Campion, said in an email that Depo-Medrol “has over 50 years of clinical use with a well-established safety profile when administered properly.”

There is no comprehensive system to track complications related to steroid injections, or any other drugs. While the FDA requires manufacturers to report harmful results they learn of, health care professionals are under no such obligation.

Until about a decade ago, the kinds of injuries Parrish suffered weren’t thought to be a possible effect of epidural steroid injections, according to doctors who specialize in pain treatment. They said the most common consequences they saw were relatively minor, such as headaches.

Then researchers and malpractice insurance companies began learning of cases of people becoming paralyzed and even dying after receiving the shots, recounting the phenomenon in alerts to doctors and in medical publications.

For Rollie Parrish, who worked as a painter for the city of Beaumont, Texas, the goal was getting relief from neck and shoulder pain so he could enjoy Christmas in 2007, according to his wife. His doctor referred him to anesthesiologist Ravi Halaswamy, who specializes in treating pain.

On Dec. 13 at Christus St. Elizabeth Hospital in Beaumont, Parrish received a shot of two steroids — dexamethasone and Kenalog — in the middle of his neck. Halaswamy inserted the needle into an area where nerve roots exit the spinal canal, the lawsuit against Halaswamy said.

Within seconds, the lawsuit said, the upper left part of Parrish’s body began contracting in signs of a stroke. A breathing tube was inserted, and critical care experts decided Parrish should undergo surgery to relieve swelling in his brain, the lawsuit said. It said he was left with what hospital records described as “terminal and irreversible” symptoms. Three weeks later, he was diagnosed as being in a “locked-in” state that the lawsuit described as similar to being buried alive. While Parrish was able to hear and see, he couldn’t respond because his muscles were paralyzed.

Intense physical, psychological and speech therapy have allowed him to speak again, Valinda Parrish said. The lawsuit claimed he wasn’t warned brain injury was a possible consequence and said that if he had been, he probably would have declined the procedure.