Archived - New contraindications for medications containing ergotamine and dihydroergotamine by Novartis Pharmaceuticals Canada Inc. - Consumer Information - For the Public

Starting date:

February 18, 2003

Posting date:

February 18, 2003

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-1900065

This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Important Drug Safety Information
New Contraindications for Medications Containing Ergotamine and Dihydroergotamine

Novartis is cautioning physicians and patients about the risk of stroke and/or gangrene when medications containing ergotamine or dihydroergotamine are taken at the same time as certain antibiotic, antiviral and antifungal drugs

DORVAL, Quebec (February 18, 2003) -- Following discussions with Health Canada, Novartis Pharmaceuticals Canada Inc. has informed physicians and pharmacists, through a Dear Health Professional Letter, that prescription products containing ergotamine (er-gotah-meen) or dihydroergotamine (dye-hi-dro-er-go-tah-meen) must not be taken with drugs that can cause the amount of ergotamine in the body to rise to toxic levels. This new CONTRAINDICATION applies to the following Novartis products:

Used as Migraine Therapy:

• MIGRANAL® (dihydroergotamine mesylate) nasal spray
• DHE (dihydroergotamine mesylate injection USP) injectable
• CAFERGOT® (ergotamine tartrate and caffeine) suppositories and tablets
• CAFERGOT-PB® (ergotamine tartrate, caffeine, belladona alkaloids and pentobarbital) suppositories Used for symptoms associated with menopause:
• BELLERGAL® Spacetabs® (belladonna alkaloids, ergotamine tartrate and phenobarbital) tablets

These five products must not be taken at the same time as drugs that strongly inhibit certain liver enzymes ("CYP 3A4" enzymes) because the breakdown of ergotamine in the body is slowed down by these drugs. This can lead to high levels of ergotamine in the body, which can cause serious decreases in blood flow to the brain or to the limbs (known as vasospasm or ischemia). Cases of stroke and gangrene have been reported from ergot toxicity, with some cases resulting in death or amputation.

Patients should be aware that the symptoms of a blood flow problem include: persistent numbness or tingling in the fingers or toes; ice-cold limbs; muscle pain, cramps and/or weakness in the arms or legs. Patients should contact their physician immediately, or go to the hospital, if one or more of these symptoms develops.

Examples of drugs that are strong "CYP 3A4" liver enzyme inhibitors include:

• Protease inhibitors used in the treatment of HIV such as ritonavir, nelfinavir, indinavir, saquinavir,
• Macrolide antibiotics such as erythromycin, clarithromycin
• Antifungal agents such as ketoconazole, itraconazole, fluconazole, clotrimazole

There are additional medications and products which are not CONTRAINDICATED, but which may also pose a potential risk of ischemia when taken with ergotamine-containing products; these include:

• Several anti-depressant medications, such as nefazodone, fluoxetine and fluvoxamine, as well as grapefruit juice.

These lists are not exhaustive, and therefore patients and their doctors should consider the effects of taking other drugs (including prescription, over-the-counter and alternative) at the same time as products containing ergotamine or dihydroergotamine. In addition, products containing ergotamine or dihydroergotamine should not be taken every day, nor taken to prevent symptoms.

Novartis has sent a health care professional letter to Canadian physicians and pharmacists informing them of these important new contraindications associated with BELLERGAL® Spacetabs®, CAFERGOT®, CAFERGOT-PB®, DHE® and MIGRANAL® to enable them to optimally counsel patients. The Product Monographs for these drugs will be revised to reflect the above changes, and will also be expanded to provide additional background information.

ABOUT NOVARTIS

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2001, the Company invested $34 million in research and development. Novartis Pharmaceuticals Canada Inc. employs over 700 people in Canada and its headquarters are located in Dorval, Quebec. The Novartis Group (NYSE:NVS) is also represented in Canada by Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation and Gerber (Canada) Inc.), and CIBA Vision Canada Inc. For further information about Novartis Canada, please consult http://www.novartis.ca

For further information, please contact:

Jason Jacobs
Director, Communications
Novartis Pharmaceuticals Canada Inc.
Tel.: (514) 633-7872

* BELLERGAL®, Spacetabs®, CAFERGOT®, CAFERGOT-PB® and MIGRANAL® are registered trademarks of Novartis Pharmaceuticals Canada Inc.

Any suspected adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.