Friday, April 1, 2011

Apr2011 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: Shingles vaccine (Zostavax) age indication expanded; topiramate safety alert; Embeda capsules recalled; OTC proton pump inhibitor (PPI) safety warning modified. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Zoster (Shingles) Vaccine (Zostavax®) — FDA Lowers Age Approval
The U.S. Food and Drug Administration and Merck announced an expansion of the approved age of 60 years and older for Zostavax administration in the prevention of herpes zoster — commonly referred to as shingles. The added approval for adults 50 to 59 years of age was based on the results of a large clinical trial that showed a 70% reduction in the risk of vaccinated persons developing shingles when compared with those receiving placebo. For more information, read the FDA Press Release regarding the expanded indication and the Pain-Topics UPDATES posting on shingles and postherpetic neuralgia. Following an American Society of Health-System Pharmacists report of a product shortage, Merck explained that Zostavax can be ordered but the maker is experiencing 2 to 4 month shipping delays at this time.

Topiramate — FDA Safety Alert
In a safety communication during March 2011, the FDA alerted healthcare professionals and consumers to the risk of birth defects in babies born to mothers taking topiramate (including Topamax® and generic versions). Topiramate is an antiepileptic agent that is also approved as prophylactic therapy for migraine headache in adults. As a result of new data that show an increased risk for the development of cleft lip and/or cleft palate in babies born to women treated with topiramate during pregnancy, the drug is now classified as a Pregnancy Category D product. This categorization indicates that there is evidence of human fetal risk based on human risk data but that the benefits of using the drug may be acceptable in certain situations in spite of the risks. For complete information, read the FDA Drug Safety Communication, the prescribing information, and the Medication Guide for this product.

Recall — EMBEDA® (Morphine Sulfate & Naltrexone Capsules) Defective
King Pharmaceuticals, a subsidiary of Pfizer, notified U.S. pharmaceutical retailers and wholesalers of a voluntary recall of approximately 100,000 bottles of the opioid pain medication EMBEDA. The Schedule II extended-release capsules did not meet pre-specified product stability standards and all dosage forms of the pain reliever were recalled. King issued a statement saying that patients can continue to take EMBEDA capsules they already have because the issue "is unlikely to pose a safety risk to patients using EMBEDA as prescribed." Patients should contact their prescribing physician to discuss alternate pain management therapy and should not abruptly discontinue taking EMBEDA. It is not known when the product will be available again. A pop-up notice at the website provides a Medical Information toll-free number of 800-776-3637 for questions or to report an adverse health effect.

FDA Says Warning on OTC Proton Pump Inhibitors (PPIs) is Unnecessary
In March 2011, the FDA reversed an earlier notice and said that PPIs available over the counter (OTC) do not warrant a warning regarding an increased risk of hip, wrist, and spine fracture — as originally announced in May 2010. Further data analysis showed that the greatest risk of fractures was in patients receiving high doses of prescription PPIs and/or those who used a PPI for one year or more. Consumers are reminded that OTC PPIs are intended to be used at low doses for only a 14-day course of treatment up to 3 times per year and should be used according to label instructions. The FDA also alerted healthcare professionals to be aware that recommending use of OTC PPI products more aggressively could increase a patient’s risk for fracture. The FDA Drug Safety Communication provides additional information. (NOTE: This action overrides our earlier notice last June 2011 [here] announcing the FDA warning on PPI products.)