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Archived – Important Safety Information for Patients Taking LAMICTAL (lamotrigine) – GlaxoSmithKline Inc. – For the Public
- Starting date:
- September 27, 2004
- Posting date:
- September 27, 2004
- Type of communication:
- Public Communication
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- General Public
- Identification number:
- RA-19000170
This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
PUBLIC ADVISORY
Health Canada Endorsed Important Safety Information on LAMICTAL (lamotrigine)
Subject: Important safety information for patients taking Lamictal® (lamotrigine)
Mississauga, Ontario (September, 2004) -- GlaxoSmithKline Inc., following discussions with Health Canada, is informing patients of new safety information regarding Lamictal® (lamotrigine), a medication for the treatment of epilepsy.
A recently completed study has demonstrated that when Lamictal is used in combination with birth control pills, the amount of the active ingredient (lamotrigine) in the blood was significantly reduced. As a result, the dose of Lamictal may need to be adjusted in patients who are also taking birth control pills, or other female hormonal treatments.
In addition to the study, there has also been a limited number of reports of seizures, unexpected pregnancies and of menstrual bleeding disorders (e.g. breakthrough bleeding) occurring in patients who were taking both Lamictal and birth control pills or other hormonal treatments.
Women taking Lamictal are advised to inform their doctor if they are also taking birth control pills, or other female hormonal treatments, like hormone replacement therapy. They should not start or stop these medications without consulting their doctor. They should also promptly notify their doctor if they experience changes in menstrual pattern (e.g., break-through bleeding) while receiving Lamictal in combination with these medications.
GlaxoSmithKline has sent a letter to healthcare professionals informing them of the new safety information. This information may be obtained on the Canadian website of GlaxoSmithKline (www.gsk.ca/en/) or on the website of the Therapeutic Products Directorate of Health Canada.
The company is working with Health Canada to revise the Canadian prescribing information for Lamictal. If patients have questions regarding their current Lamictal prescription, they are asked to contact their doctor or pharmacist.
For media inquiries, please contact Cathy Metson or Alison Steeves, (905) 819-3363.
Lamictal® is a registered trademark, used under license by GlaxoSmithKline Inc.
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information.
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.