Friday, January 1, 2010

Jan2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: Tylenol Arthritis Pain Caplets recall, diclofenac sodium topical gel (Voltaren gel) hepatic toxicity warning, generic hydromorphone HCl approved.
— Brand names are trademarks of the respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Tylenol® Arthritis Pain Caplets — Product Recall Expanded
Johnson & Johnson has announced a voluntary, precautionary recall of all 100-count bottles of Tylenol Arthritis Pain Caplets with the red E-Z Open Cap. Consumers have reported a mildew-like smell and complaints of nausea, vomiting, stomach pain, and diarrhea. None of the health complaints have been serious and all were temporary. The company believes that the odor was caused by trace amounts of a chemical in the wooden pallets that are used to transport and store the product before shipping. J & J plans to ship new bottles of Tylenol Arthritis Pain Caplets in January. Consumers can receive a product refund by calling the company at 888-222-6036.

Diclofenac Sodium Topical Gel (Voltaren®) — Stronger Hepatic Toxicity Warning
The FDA issued a December 2009 “Dear Healthcare Professional…” letter to alert clinicians of a revision in the prescribing information for diclofenac sodium topical gel. Post-marketing surveillance has identified reports of drug-induced hepatic toxicity — occasionally severe enough to result in death or liver transplantation — including liver necrosis, jaundice, fulminant hepatitis, and liver failure. Because hepatotoxicity cases have been reported within the first month or two of treatment, liver enzyme tests (specifically, aspartate transaminase and alanine transaminase) should be performed within 4 to 8 weeks of treatment initiation. Voltaren gel should be used cautiously when prescribing for patients already taking drugs known to be potentially hepatotoxic (eg, antibiotics, anti-epileptic drugs); the lowest effective dose should be used for the shortest time possible. To learn more, see the full prescribing information and the letter to healthcare professionals.

Generic Hydromorphone Hydrochloride Approved
Lannett Company announced the December 2009 FDA approval of their hydromorphone hydrochloride tablets, the generic equivalent of Purdue Pharmaceuticals’ Dilaudid®. News sources have reported market shortages for hydromorphone and Lannett expects to be able to ship all 3 dosage strengths — 2 mg, 4 mg, and 8 mg tablets — within several weeks. Hydromorphone is a potent schedule II opioid agonist used for the management of moderate to severe pain.