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Epilepsy Newfoundland and Labrador
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| Drug Alert Notices | |
PUBLIC ADVISORY Health Canada Endorsed Important Safety Information on 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 (New Window http://www.gsk.ca/en/) or on the website of the Therapeutic Products Directorate of Health Canada (http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advisories_professionals_e.html). 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.
Disclaimer
The materials contained on the Epilepsy Newfoundland and Labrador website are to provide general information about epilepsy to the public. The information presented is not intended as medical or legal advice. Epilepsy Newfoundland and Labrador, its employees, board members, medical advisors, volunteers, agents and sponsors do not assume responsibility for inaccuracies or omissions or for the consequences from the use of the information obtained over this site or any links accessed through this site. Epilepsy Newfoundland and Labrador is not liable for any outcome or damages resulting from information in either a direct or indirect form. We recognize that each individual's experience of epilepsy is different. Consult your physician and/or neurologist with any questions you have.
People with epilepsy should never discontinue anti-epileptic medications or make changes in activities unless specifically advised to do so by an attending physician.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use this medication only for the condition prescribed.
