Tuesday, June 1, 2010

June2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: intranasal ketorolac tromethamine (Sprix Nasal Spray) approval; milnacipran HCl (Savella) safety warning; tramadol-related suicide warning (Ultram and Ultracet); proton pump inhibitor (PPI) class-wide safety notice. — Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Intranasal Ketorolac Tromethamine (Sprix™ Nasal Spray) — FDA Approved
Roxro Pharma announced the May 2010 approval of an intranasal formulation of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID) absorbed through nasal mucosa. The novel intranasal formulation — indicated for the short-term management of moderate to moderately-severe pain — has been shown to achieve peak blood levels as quickly as an intramuscular injection. Data from 4 controlled, efficacy trials reported meeting primary endpoints in each trial and phase 3 studies in surgical patients reported statistically significant reductions in measures of pain during 48 hours versus placebo. The easy-to-use intranasal formulation also showed a 26%-36% reduction in morphine use during a 48-hour period when compared with placebo. All ketorolac formulations should be prescribed for the shortest duration possible, not exceeding 5 days. The most frequently reported adverse effect was mild, transient nasal discomfort. Intranasal ketorolac is contraindicated in patients with a history of cerebrovascular bleeding, gastrointestinal bleeding, or advanced renal impairment. For complete information, see the Sprix prescribing information, Medication Guide, and patient instructions (combined) at the Roxro Pharma website.

Milnacipran HCl (Savella®) — Safety Warning
The FDA issued a February 2010 warning to alert practitioners that a potentially life-threatening reaction can occur with SNRIs and SSRIs, including Milnacipran HCl (Savella), which was approved in 2009 for the treatment of fibromyalgia symptoms. Serotonin syndrome symptoms or neuroleptic malignant syndrome-like reactions can include changes in mental status, neuromuscular aberrations, autonomic instability, or gastrointestinal symptoms. Reports have been primarily associated with concomitant use of dopamine antagonists. Read the FDA safety warning and the new label, approved in May 2010.

Tramadol HCl (Ultram®) and Tramadol HCl/acetaminophen (Ultracet®) — Suicide Warning
The FDA and PriCara, the maker of 2 formulations of tramadol — a centrally-acting synthetic opioid analgesic — announced that a warning of suicide risk has been added to the labels of Ultram and Ultracet. The drugs are used for the management of moderate to moderately severe chronic pain. Following reports of tramadol-related deaths in patients with emotional disturbances, suicidal ideation, or histories of drug or alcohol misuse, the revised label instructs prescribers to use caution in patients with similar histories. Tramadol can intensify the effects of other opioids, alcohol, or illicit drugs that cause central nervous system depression. See the FDA notice and “Dear Healthcare Professional” letters for each product for further information.

Proton Pump Inhibitors (PPIs) — Class-wide Labeling Revision The FDA announced a May 2010 safety revision to the prescription and over-the-counter (OTC) labels for the class of drugs known as proton pump inhibitors (PPIs). The new warning cautions healthcare providers and consumers of a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications — including Nexium®, Prilosec,® Prevacid®, Protonix®, Aciphex®, Vimovo™, Dexilant™, and Zegerid® formulations. This is an important concern for patients taking PPIs to manage gastroesophageal reflux disease or for those taking a proton pump inhibitor as gastroprotective therapy when using nonsteroidal anti-inflammatory drugs (NSAIDs) for chronic pain and inflammation. Analysis of several studies, primarily of adults 50 years of age and older, showed that people who had been taking high-dose prescription PPIs or used them for at least one year had the greatest increased risk of fracture. Healthcare providers are encouraged to consider the risk-benefit ratio and evaluate the potential value of a lower dose or shorter course of therapy on a case-by-case basis. For complete information, including the epidemiological study references supporting the fracture risk evaluation, see the FDA safety communication.
Note: In March 2011, the FDA reversed their decision and decided that a warning on OTC PPI products regarding bone fracture was unwarranted. See FDA notice [here].