Saturday, May 1, 2010

May2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: naproxen+esomeprazole (Vimovo) FDA approved; recall – children’s/infant’s Tylenol, Motrin, Zyrtec, and Benadryl; lidocaine patch 5% (Lidoderm) labeling revision; oxycodone controlled-release (OxyContin) reformulation approval.
— Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Naproxen + Esomeprazole (Vimovo™) — FDA Approved
The U.S. Food and Drug Administration has approved AstraZeneca Plc and Pozen Inc's pain drug Vimovo. This is a fixed-dose combination of the anti-inflammatory drug naproxen and an immediate release version of esomeprazole, a proton pump inhibitor and the active ingredient in AstraZeneca's acid reflux treatment Nexium®. Vimovo was approved for relieving symptoms of osteoarthritis, rheumatoid arthritis, and a type of spinal arthritis called ankylosing spondylitis. It also was cleared for decreasing the chances of gastric ulcers in patients at risk of developing them from use of nonsteroidal anti-inflammatory drugs, or NSAIDs. Press release [here].

Recall — Children’s/Infant’s Tylenol®, Motrin®, Zyrtec®, and Benadryl®
McNeil Consumer Healthcare and the FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) children’s and infants’ liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products. Some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children or infants. These products were distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago, and Kuwait. See announcement [here].

Lidocaine Patch 5% (Lidoderm®) — Labeling Revision
Endo Pharmaceuticals has provided additional safety information to the Lidoderm label. The Lidoderm patch is a local anesthetic used to treat post-herpetic neuralgia, a pain disorder than sometimes follows shingles. The 'Precautions' section of the label contains a new subsection on 'External Heat Sources' to alert patients that additional heat from sources such as electric blankets should not be used over the Lidoderm patch. Read the April 2010 revised label for full information.

Oxycodone HCl (OxyContin®) — New Controlled-Release Tablet Approval
Purdue Pharma announced the April 2010 approval of a new controlled-release formulation of the opioid pain-reliever OxyContin. This reformulation has been designed to prevent the tablet from being cut, broken, chewed, crushed, or dissolved — to discourage misuse and abuse of the medication. The new OxyContin tablets will be produced in 7 different dosing strengths and are scheduled to be available during the 3rd quarter of 2010. At that time, the original controlled-release formulation of the product will be discontinued. As required by the FDA's Risk Evaluation and Mitigation Strategy (REMS) program, Purdue has provided Prescribing Information and a Medication Guide (combined) for the new OxyContin product.