FDA Warns Pacira for Misleading Administration Guides and Advertisement
The FDA warned Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel, but the company says its labeling can back up the claims.
In a Sept. 22 warning letter, the agency cited problems with the company’s administration guide and journal ad for Exparel (bupivacaine liposome injectable suspension), which is approved as a postsurgical analgesic for bunion and hemorrhoid removal surgeries.
The administration guide, however, suggests Exparel is appropriate for various unapproved uses, the agency said. For instance, the guide describes specific techniques for using Exparel in laparoscopic cholescystectomy, a procedure to remove gallstones, and in open colectomy to remove part of a patient’s colon, the FDA said.
These claims suggest that Exparel is safe and effective for use in cholecystectomy and colectomy but such uses haven’t been approved by the FDA, the letter said.
The FDA also took aim at a journal ad that claimed Exparel offered pain control for up to 72 hours. The drugmaker cites the clinical trial for hemorrhoid removal surgery as evidence of the claim. However, the FDA found that neither that trial nor the one for bunion surgery were able to support claims regarding pain control beyond 24 hours.
The letter said Pacira should stop distributing the ad and administration guide.
The drugmaker said that it believes Exparel’s current labeling supports the claims being challenged by the FDA. “We plan to explain our position to the FDA,” Pacira CEO David Stack said in a statement.
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