Monday, November 1, 2010

Nov2010 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: botulinum toxin type A (Botox) approval, generic oxycodone hydrochloride 5 mg capsule approval, methotrexate recall, fentanyl transdermal system recall.
— Brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Botulinum Toxin Type A (Botox®) —Approved by FDA For Chronic Migraine
Allergan received an October 2010 U.S. Food and Drug Administration approval for Botox as chronic migraine prevention therapy. The product is intended for patients who experience migraine headaches 14 or more days per month. Treatment involves multiple Botox injections in the muscles of the head and neck approximately every 12 weeks to reduce future headache symptoms. Approval was based on 2 controlled trials of more than 1,300 patients, with results showing that treated patients had slightly fewer headache days than patients who received the sham treatment. The 2 most frequent adverse reactions reported by participants in the treatment group were neck pain and headache. It may be important to note that Botox treatment can be costly in comparison with other preventive therapies and may not be approved for insurance coverage. For full product information, see the prescribing information and medication guide for Botox.

Oxycodone Hydrochloride 5 mg Capsules — Generic Approval
Lehigh Valley Technologies received an October 2010 FDA approval of their 5 mg formulation of oxycodone hydrochloride. This synthetic opioid, a Schedule II drug, is indicated for moderate to severe pain relief when the use of an opioid analgesic is appropriate. The product is available only in 5 mg capsules and is contraindicated in patients with respiratory depression; also, it should be used cautiously in patients who suffer from chronic obstructive pulmonary disease or other disorders that reduce respiratory reserve. For full information on dosing and administration, see the prescribing information.

Recall — Methotrexate Vials Recalled
Two manufacturers of injectable methotrexate—Sandoz and Parenta—have announced a recall of 24 product lots. Some vials were found to contain small flakes of glass which may have been the result of vial delamination. Methotrexate is a drug that is sometimes used in combination with other medications to treat the symptoms of painful autoimmune diseases, like rheumatoid arthritis. Adverse events have not been reported to date, but company representatives have asked practitioners and patients to check the lot numbers in their possession and stop using any lots listed in the recall. For a full list of the lot numbers included in the recall, see the news story at MedPage released on October 28, 2010.

Recall — Fentanyl Pain Patches
The FDA and Actavis Inc. have announced a recall of 18 lots of their 25 mcg/hour Fentanyl Transdermal System. These fentanyl patches are designed to release a controlled stream of opioid analgesic through the skin. One lot was found to release the active ingredient too rapidly during laboratory testing. For a patient who is at higher risk for respiratory depression, an accelerated release could increase the risk of an adverse event. As a precaution, the company has recalled an additional 17 lots with a request to retail pharmacies and wholesale distributors to return all affected lots. However, the American Pain Foundation asked Actavis to extend their recall to consumers. Gerard Farrell of Actavis Corporate Communications replied favorably by stating: “Individuals who have these lots in their possession and want to return their 25 mcg/h Fentanyl patch can call # 877-422-7452 and an Actavis representative will assist them with their return.” A full list of the lot numbers included in the recall can be found at the Actavis website.