Thursday, March 3, 2011

Mar2011 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: proton pump inhibitor drugs safety warning; gabapentin oral solution approval; sumatriptan subcutaneous injection (Alsuma Auto-Injector) product availability; recall implantable drug pump (Medtronic SynchroMed); recall hydrocodone bitartrate and acetaminophen tablets. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

FDA Safety Warning — Proton Pump Inhibitors May Cause Low Magnesium
The U.S. FDA has announced that proton pump inhibitors, or PPIs, often referred to class-wide as “prazoles,” may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements, but in about one-quarter of cases, supplementation alone may not improve low magnesium levels and the PPI must be discontinued. PPIs — often taken by patients with pain to counteract gastrointestinal adverse effects of NSAIDs — include esomeprazole, dexlansoprazole, pantoprazole, rabeprazole, a prescription combination product containing esomeprazole magnesium and naproxen, omeprazole, omeprazole and sodium bicarbonate, and lansoprazole. The latter 3 products also are available over-the-counter. See the latest FDA Drug Safety Communication on PPIs, including guidance and data summary [here]. Last May 2010 a class-wide warning was issued regarding increased risk of fractures of the hip, wrist, and spine with the use of PPIs [see UPDATE here].

Gabapentin Oral Solution — Generic Approval
Hi-Tech Pharmacal received a February 2011 FDA approval for their generic gabapentin oral solution — a therapeutic equivalent of Pfizer’s Neurontin oral solution. The product is indicated for the treatment of postherpetic neuralgia and epilepsy and is available in one strength, 250 mg/5 mL. Due to the fact that the FDA also granted generic market exclusivity for 180 days, Hi-Tech is planning to launch the product immediately. Please read the package insert and medication guide for more information.

Sumatriptan Subcutaneous Injection (Alsuma™ Auto-Injector) — Now Available for Acute Migraine Attack
King Pharmaceuticals and U.S. WorldMeds announced the February 2011 availability of the Alsuma Auto-Injector — a single-use, prefilled auto-injector that delivers a 6 mg dose of sumatriptan. The subcutaneous treatment received a June 2010 FDA approval for patients with an established diagnosis of migraine or cluster headache to treat acute migraine attacks, with or without aura, as well as acute episodes of cluster headache. It is not intended for hemiplegic or basilar migraine attacks or as prophylactic therapy. The approval was based on 2 clinical trials involving more than 1,100 patients who experienced a moderate or severe migraine attack. Results showed that the criteria for headache reduction were achieved within 1 hour in 70% of treated patients compared with 26% of patients receiving placebo. Further information can be found in the patient information handout.

Recall Safety Alert — Medtronic Implantable Drug Pump
In January 2011, the FDA and Medtronic, Inc. reported a class I recall of two Medtronic SynchroMed® implantable infusion pumps (models II and EL) due to serious safety concerns for patients who require the pump for constant delivery of drugs, including therapy for chronic pain. There have been reports of unintentional injection of the full dose of a drug into the patient’s subcutaneous tissue instead of into the pump for gradual administration. A class I recall involves situations in which there is a reasonable possibility of serious adverse events or death. The FDA MedWatch Safety Alert provides additional information for healthcare professionals.

Recall — Hydrocodone Bitartrate and Acetaminophen Tablets, Package Incorrectly Labeled
Qualitest Pharmaceuticals has announced a recall of 3 product lots of Hydrocodone Bitartrate and Acetaminophen tablets (10 mg/ 500 mg) after a bottle of the combination product was discovered to be incorrectly labeled as Phenobarbital. Patients who have bottles of Hydrocodone Bitartrate/Acetaminophen tablets or Phenobarbital tablets with lot numbers T150G10B, T120J10E, and T023M10A should stop using the products immediately and contact Qualitest at 800-444-4011 for reimbursement. Unintentional use of hydrocodone can lead to serious adverse events including depression, coma, and death. The FDA MedWatch Safety Alert provides further information.