Nitroglycerin ER Discontinuation Memo

INTEROFFICE MEMORANDUM

To: MAPMG Physicians, Nurse Practitioners, Date: May 11, 2011 Physician Assistants, Pharmacists

Subject: PRODUCT DISCONTINUATION: From: Sheireen Huang, Pharm.D. Nitroglycerin ER 2.5 mg, 6.5 mg and 9 Manager, Clinical Pharmacy Services mg Capsules (ALL Manufacturers) and Carol Forster, MD Physician Director, Pharmacy and Therapeutics/ Medication Safety

Situation: All nitroglycerin extended-release (ER) capsules have been discontinued. This memo provides information on this discontinuation and action steps to minimize the impact of this change on Kaiser Permanente members.

Background: Extended-release nitroglycerin is used in the management of stable angina as a vasodilatory agent to relax vascular smooth muscle and facilitate dilatation of peripheral veins and arteries.

Nitroglycerin ER is a Drug Efficacy Study Implementation (DESI) drug that was introduced prior to 1962 and grandfathered onto the US market without data to support efficacy and safety. All manufacturers (brand and generic) have discontinued manufacturing these products in response to a Food and Drug Administration (FDA)-imposed market withdrawal. To date, no manufacturer has announced an intention to submit efficacy data to the FDA for formal approval.

Supplies of nitroglycerin ER capsules in the region are very low. Patients with active prescriptions will need to be re-evaluated for an alternative medication.

The following nitrate products are available as alternatives to nitroglycerin ER capsules: • Isosorbide dinitrate (generic Isordil) - 10 mg to 20 mg orally 3 times daily • Isosorbide mononitrate (generic Ismo, Imdur) – 30 mg to 60 mg orally once daily

Assessment: All nitroglycerin ER capsules have been discontinued and are no longer available. Patients with active prescriptions will need to be re-evaluated and an alternative medication prescribed.

Recommendations/Action Requested: 1. Please do not prescribe or approve refills for nitroglycerin ER capsules. 2. Please respond promptly to conversion requests from the pharmacy to prevent any disruption in therapy. 3. Contact your Medical Office Building’s Primary Care Clinical Pharmacy Specialist with any questions.

Thank you for your assistance with this market discontinuation.