Tuesday, May 1, 2012

May 2012 – Pain Product Announcements & Warnings

Pain Product Warnings Featured Items: rotigotine transdermal system (Neupro) approved for RLS; adalimumab (Humira) European approval for colitis; fentanyl patch safety alert; proton pump inhibitor (PPI) alert for C. difficile-associated diarrhea; Savella and Neurontin added to FDA Watch list; morphine sulfate injectable recall. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Rotigotine Transdermal System (Neupro®) – approved for RLS
U.S. Food and Drug Administration (FDA) officials gave UCB, Inc. an approval in April 2012 to market Neupro for the treatment of core symptoms in moderate-to-severe primary restless legs syndrome (RLS). This continuous delivery skin patch contains the dopamine agonist rotigotine which is believed to work by stimulating dopamine receptors in areas of the brain that regulate movement. This approval also included the indication of advanced stage idiopathic Parkinson's Disease, and the drug was previously approved for the signs and symptoms of early-stage idiopathic Parkinson's Disease. Approvals were based on results of 5 randomized, double-blind placebo-controlled trials, with 2 fixed-dose trials providing efficacy data for the treatment of RLS. The most common adverse effects reported included nausea, application site reactions, somnolence, dizziness, and headache. The patch should not be used by pregnant women or patients who have allergic-type reactions to sulfites. See the Neupro Prescribing Information for full administration and safety instructions.

Adalimumab (HUMIRA®) – Approved in Europe for Ulcerative Colitis
Abbott Laboratories announced a European Commission approval in April of adalimumab (HUMIRA) for the adult treatment of moderately-to-severely active ulcerative colitis (UC) in patients who have not experienced adequate response to conventional therapy. Ulcerative colitis is a difficult-to-treat chronic disease that causes inflammation in the colon and rectum and can lead to life-threatening complications. Adalimumab is the only self-injectable biologic therapy for UC, but has previously been approved for other inflammatory diseases like rheumatoid arthritis, chronic plaque psoriasis, severely active Crohn's disease, and others. Adalimumab affects the immune system and treated patients can be at increased risk for developing serious systemic infections, including tuberculosis. An ulcerative colitis indication for adalimumab is still under consideration in the U.S. For complete administration and safety information, see the Medication Guide and Prescribing Information.

FDA Safety Reminder – Harm from Accidental Fentanyl Patch Exposure
In an April 2012 FDA drug safety communication, patients and healthcare professionals were reminded of the potential for life-threatening harm from accidental exposure to fentanyl. Patches should be stored safely and discarded in a manner that will not allow exposure to others, especially children; used patches contain enough fentanyl to be harmful to children. In a recent evaluation of 26 cases of accidental exposure, 16 cases involved children aged 2 years or younger and 10 of those resulted in death. For further information, read the complete Safety Reminder.

FDA Drug Safety Alert – Risk of C. Difficile-Associated Diarrhea with PPIs
The FDA issued a safety announcement in February 2012 to alert patients and healthcare professionals that evidence shows a possible link between Clostridium difficile –associated diarrhea (CDAD) and the use of proton pump inhibitors (PPIs) to reduce stomach acid. At this time, the FDA is working with manufacturers to add warnings to drug labels for prescription and over-the-counter PPI drugs administered for the symptoms of heartburn and gastroesophageal reflux disease (GERD). The FDA suggests that a diagnosis of CDAD should be considered in patients taking PPIs who develop diarrhea that does not improve. The FDA safety communication provides further information and a full list of PPIs.

Added to the FDA Watch List - Milnacipran (Savella) and Gabapentin (Neurontin)
In addition to FDA concerns regarding PPIs, the FDA has added to the Watch list two other products that are occasionally prescribed in pain conditions. Forest Pharmaceutical's milnacipran (Savella), used in the management of fibromyalgia, has been identified as a drug that needs to be monitored for the potential of incurring homicidal ideation. Pfizer's gabapentin (Neurontin) has been reportedly linked to an increase in blood creatine phosphokinase levels and rhabdomyolysis. The FDA will continue to monitor these drugs through the Adverse Event Reporting System (AERS) before determining if they are truly associated with a health risk. See the full list of drugs added to the Watch List in the first quarter of 2012 for additional information.

Product Recall — Morphine Sulfate Injectable
Hospira and the FDA notified U.S. pharmaceutical retailers and patients regarding a recall of one lot of prefilled glass cartridges used with the Carpuject Syringe system (Lot Number 10830LL, expiration date April 1, 2013). In at least 2 reported cases, cartridges contained more than the 1 mL labeled fill volume. The lot was distributed in January 2012 to wholesalers and also to some hospitals in 10 states. If inventory with this lot number is identified, do not use the product and call Stericycle at 888-912-7088 for product return information. See the Recall Announcement for additional information.

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