Wednesday, August 3, 2011

Aug 2011 – Pain Product Announcements & Warnings

Announcements Featured Items: fentanyl nasal spray (Lazanda) approved for cancer pain; mesalamine (Lialda) approved for ulcerative colitis remission maintenance; acetaminophen (Extra Strength Tylenol) maximum daily dosing change & recall; Actiq and Fentora REMS released. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

FDA Approves Fentanyl Nasal Spray (Lazanda®) for Cancer Pain
Archimedes Pharma announced a June 2011 U.S. Food and Drug Administration approval for their fentanyl nasal spray to manage breakthrough pain in adult patients with cancer. Lazanda — the first fentanyl nasal spray approved in the U.S. — is a Schedule II controlled substance for patients who are opioid-tolerant and already receiving opioids for persistent cancer pain. The product uses the proprietary PecSys drug delivery system designed to deliver fentanyl in a rapid, controlled, fine mist spray to the mucus membrane. Lazanda has already been approved in five European countries under the brand name PecFent (fentanyl pectin nasal spray). FDA approval was based on 3 double-blind, placebo-controlled trials in more than 500 patients with cancer who experienced breakthrough pain. The treated patients reported a statistically significant reduction in pain, from baseline to 30 minutes following therapy, compared with those receiving placebo.

The most commonly reported adverse effects were consistent with opioid therapy and included vomiting, nausea, fever, and constipation. Archimedes Pharma reminds healthcare providers that this formulation is not equivalent to other fentanyl products administered for breakthrough pain. For complete information — including contraindications, warnings, and precautions—read the Prescribing Information, Medication Guide, and REMS documentation available the resources website. Archimedes plans to make the drug available commercially during the third quarter of 2011.

Mesalamine (Lialda®) — Now FDA Approved for Maintenance of Ulcerative Colitis Remission
The FDA granted a July 2011 approval of Shire’s Lialda brand of mesalamine for the maintenance of remission of ulcerative colitis (UC). Lialda — originally approved in 2007 for the induction of remission of ulcerative colitis — now also provides a once-daily option for the maintenance of remission in patients with active, mild-to-moderate UC. The approval was based on a 6-month multicenter, randomized, double-blind study conducted in more than 800 adult patients in UC remission. Delayed-release Lialda tablets were administered once a day (2.4 g) or twice daily (0.8 g) with results showing that 83% and 81% of patients, respectively, maintained remission at the 6-month follow-up. Three studies, between 6 and 14 months in length, evaluated the safety of Lialda. The most common severe adverse effects were gastrointestinal disorders, not inconsistent with symptoms usually associated with UC. Other less severe side effects included headache, abnormal liver function tests, and abdominal pain. Due to reports of kidney function problems in patients taking mesalamine-containing products, patients should have kidney function testing before Lialda therapy is initiated. For complete administration and safety recommendations, read the prescribing information.

Extra Strength Tylenol® — Max Dose Change & Recall
McNeil Consumer Healthcare, makers of Tylenol products, made a July 2011 announcement regarding a decrease in the recommended maximum daily dose of Extra Strength Tylenol. The decision was made following increasing concerns about drug-induced liver injury — a cause of approximately 500 deaths and 56,000 hospitalizations each year. The new maximum daily dosage recommendation is six 500 mg pills, which means a reduction to a daily total of no more than 3,000 mg. The product has not changed and the drug is considered safe when used as directed. Consumers will see a package labeling revision reflecting the change during the 3rd quarter of 2011, and McNeil stated that it plans to lower the maximum daily dose for Regular Strength Tylenol and other adult products containing acetaminophen in 2012. A website designed to improve patient safety when taking Tylenol provides a search window that allows users to find out if other medications they use contain acetaminophen; see Get Relief Responsibly.

In a separate action last June 2011, McNeil Consumer Healthcare notified retailers and consumers that one lot of 225-count bottles of Extra Strength Tylenol caplets has been recalled due to concerns about an odor linked to an unwanted chemical. The lot (#ABA619) totaled more than 60 thousand bottles. Consumers can call 1-888-222-6036 between 8 am and 8 pm EDT to find out how to receive a product refund.

Actiq® and Fentora® — REMS Announced
Cephalon announced the July 2011 FDA approval of their Risk Evaluation and Mitigation Strategy (REMS) for Fentora (fentanyl buccal tablet) and Actiq (oral transmucosal fentanyl citrate), which are indicated for the treatment of breakthrough pain in opioid-tolerant adult patients with cancer. The REMS program was designed to provide a system that helps practitioners dispense the appropriate product to qualified patients, thereby reducing risk, and to educate prescribers and patients on the products. For complete information, download a PDF copy of the 82-page REMS document [here].