Friday, July 1, 2011

July 2011 – Pain Product Announcements & Warnings

Announcements Featured Items: tamper-resistant oxycodone (Oxecta) approved; painful fissure ointment (Rectiv) approved; proton pump inhibitors (PPIs) class safety alert; oxycodone/acetaminophen tablets (Endocet) recalled; two combination products (butalbital-APAP-caffeine tablets and hydrocodone bitartrate-APAP) recalled; Tylenol caplets safety recall. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Tamper-Resistant Oxycodone (Oxecta™) — FDA Approved
Pfizer and Acura Pharmaceuticals announced a June 2011 U.S. Food and Drug Administration (FDA) approval for their immediate-release pain medication Oxecta. This novel formulation uses a drug delivery system from Aversion Technology designed to reduce the incidence of abuse and tampering. The new technology discourages abuse by causing the active ingredient to gel or to irritate nasal passages, thereby hindering injection or inhalation. Oxecta is a controlled substance intended for patients with moderate to severe pain that cannot be managed by other analgesic products.

Health care providers are reminded that it remains possible to abuse this formulation of oxycodone, so patient monitoring and safety measures are necessary. Please see Oxecta prescribing information for full administration and safety recommendations. Pfizer plans to make the drug available commercially during the third quarter of 2011.

Nitroglycerin Ointment 0.4% (Rectiv™) — Available for Painful Fissures
The FDA approved ProStrakan Group’s Rectiv for the adult treatment of moderate to severe pain caused by chronic, painful anal fissures. This common ailment may cause severe pain and bleeding that can become debilitating. Rectiv — an easy-to-use topical vasodilating ointment — is the only FDA-approved prescription product for patients suffering from anal fissures. ProStrakan reports that Rectiv will be commercially available in the first quarter of 2012. See FDA labeling information [PDF here].

Proton Pump Inhibitors (PPIs) — FDA Safety Alert
In a May 2011 safety communication, the FDA alerted healthcare professionals and consumers to the increased risk of hypomagnesemia (low serum magnesium levels) in patients on proton pump inhibitors (PPIs). Labeling changes for the following drugs will reflect the safety concern: Aciphex®, Dexilant™, Prevacid®, Protonix®, Prilosec®, omeprazole, Vimovo®, and Zegerid®. Cases of hypomagnesemia were reported primarily in patients who had been on PPI therapy for at least a year, but rare cases occurred in patients on PPIs for a minimum of 3 months. Symptoms can include palpitations, dizziness, and seizures. However, low magnesium levels can be asymptomatic, so it may be appropriate to consider monitoring magnesium levels prior to beginning treatment and periodically during therapy. For complete information, read the FDA Drug Safety Communication.

Recall — Endocet® (Oxycodone-Acetaminophen) Tablets
Endo Pharmaceuticals and the FDA notified U.S. pharmaceutical retailers and patients in 18 states of a recall of 2 lots of the combination pain drug Endocet (oxycodone 10 mg and acetaminophen [APAP] 325 mg tablets). Some bottles contained tablets with APAP 650 mg, which could result in patient consumption of a greater than intended dose. For more information, including product lot numbers, see the Endo Pharmaceuticals Press Release. Endo has appointed an agent for product return and refund; call Stericycle at their toll-free number 866-723-2681.

Recall — Butalbital-APAP-Caffeine and Hydrocodone Bitartrate-APAP Tablets
Qualitest Pharmaceuticals and the FDA notified pharmacists and consumers nationwide (including Puerto Rico) of a recall of 4 lots of Butalbital-Acetaminophen (APAP)-Caffeine Tablets (USP 50 g, 325 mg, 40 mg) and Hydrocodone Bitartrate-APAP Tablets (USP 7.5 mg, 500 mg). The recall was issued after a bottle with a hydrocodone-APAP label was discovered to contain the butalbital-APAP-caffeine product. Patients taking butalbital unintentionally could experience reactions of hypersensitivity, sedation, lightheadedness, dizziness, or nausea. For full information, including lot numbers and tablet descriptions, please read the Qualitest Press Release regarding the recall.

Tylenol® Extra Strength Caplets Recall
McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recall stems from a small number of odor reports, including musty, moldy odor. The recall involves Tylenol lot ABA619, manufactured in February, 2009. The product lot number for the recalled product can be found on the side of the bottle label. Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at or by calling 1-888-222-6036. The FDA Safety Alert is available [here].