Nuvo Research Inc. has announced that its U.S. marketing partner, Mallinckrodt Inc., the Pharmaceuticals business of Covidien, has advised Nuvo that it has resumed distribution of 15 mL sample bottles of PENNSAID® (diclofenac sodium topical solution, 1.5% w/w) to U.S. healthcare professionals.
In November 2011, at the request of the U.S. Food and Drug Administration (FDA), Mallinckrodt voluntarily ceased distribution of the sample bottles in response to six reports of patients who had used the 15 mL sample bottle to incorrectly administer PENNSAID topical solution either orally (into the mouth) or optically (into the eye).
PENNSAID is a topical solution approved for direct application to the skin overlying the knee for the treatment of the signs and symptoms of osteoarthritis (OA) of the knee.
There were no serious adverse outcomes in these patients, and in all reported confirmed cases, all of the adverse events that resulted from the improper route of administration were resolved.
The sample bottles have been modified to include additional packaging and labeling information advising patients that PENNSAID is a topical treatment for the signs and symptoms of OA of the knee and that PENNSAID should only be applied topically to all four sides of the affected knee.