Thursday, April 1, 2010

April2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: hydromorphone extended-release (Exalgo) approval, unapproved nitroglycerin warnings, generic oral transmucosal fentanyl citrate available.
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.


Extended-Release Hydromorphone HCl (Exalgo™) — FDA Approved
Covidien and CombinatoRx announced the March 2010 approval of Exalgo, an extended-release hydromorphone hydrochloride tablet for opioid-tolerant adult patients with moderate to severe chronic pain. This Schedule II mu-opioid agonist uses Alza’s OROS® Push-Pull™ osmotic delivery system to provide a controlled rate of release in a once-daily formulation for patients requiring around-the-clock analgesia. Three dosage strengths were approved: 8 mg, 12 mg, and 16 mg. Exalgo was approved with a risk evaluation and mitigation strategy (REMS) program that requires an education program for healthcare providers and a patient medication guide. For more information, read the Covidien press release and the prescribing information.

Generic Oral Transmucosal Fentanyl Citrate — Now Available
Following FDA approval in October 2009, Covidien has announced the availability of their generic oral transmucosal fentanyl citrate beginning March 2010. The product is equivalent to Actiq(R) — a solid formulation of fentanyl that resembles a lozenge on a stick — and is now available through distributors and retail pharmacies.

Unapproved Nitroglycerin — 2 Makers Receive FDA Warnings
Two makers of unapproved sublingual nitroglycerin tablets — frequently prescribed for chest pain — were ordered to stop marketing their drug products and were given 15 days to respond. The nitroglycerin tablets from Glenmark Generics and Konec come in 0.3 mg, 0.4 mg, and 0.6 mg strengths and have not been FDA-approved for safety and efficacy. This removal warning is part of the FDA's Unapproved Drugs Initiative that was introduced in 2006. Both companies were given 90 days to cease manufacturing and 180 days to halt shipment of existing supplies. Read the FDA press release for more information.