Virginia Injury Lawyer Blog

FDA orders changes in pain pump labels after injuries

The issue of pain pumps is back in the news after the Food and Drug Administration directed manufacturers to change labels on the pumps in the wake of irreversible injuries inflicted by the pumps, The Wall Street Journal reported this week.

Thirty-five patients suffered severe cartilage damage after using post-surgery pain pumps to administer medication, the FDA told The Journal.

Most of the injured patients had shoulder surgery, and over 50 percent needed more surgery – including joint replacement – as a result, The Journal said.

Pain pumps automatically deliver pain medication after surgery without human intervention. “The pumps are approved to be used after abdominal and other surgeries, such as hysterectomies,” The Journal wrote. “They are considered a better way to deliver pain-relieving medications because they target specific areas and don't involve narcotics.”

But Dr. Constance Chu told the newspaper that shoulder tissue is getting doused with so much medication that it can die.

"If you don't give these tissues a break the toxicity is so high you can lose the tissue,” Chu told the newspaper.

The FDA is requiring manufacturers to note that the FDA has not cleared pain pumps for use on joint surgeries.

"The significance of this injury to otherwise healthy young adults warrants notification to health-care professionals," the FDA wrote to medical professionals earlier this month.

I-Flow Corp. and Stryker Corp. are two companies that make pain pumps. APP Pharmaceuticals and Hospira Inc. are among the companies that make the drugs used. All will have to update their labels.

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Labels: APP Pharmaceuticals attorney Hospira Inc. I-Flow Corp. lawyer pain pump Stryker Corp.