REMINYL ER (galantamine hydrobromide) - New Safety Information Regarding the Risk of Serious Skin Reactions - For the Public

Starting date:

November 18, 2014

Posting date:

November 18, 2014

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-42237

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

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on REMINYL ER (galantamine hydrobromide) Capsules

November 18, 2014

Subject: New safety information regarding the risk of serious skin reactions associated with the use of REMINYL^® ER (galantamine hydrobromide)

Janssen Inc., in consultation with Health Canada, is informing consumers about important new safety information regarding the risk of serious skin reactions associated with the use of REMINYL^® ER. This safety information also applies to generic versions of galantamine.

REMINYL^® ER is used to treat the symptoms of mild to moderate Alzheimer’s disease (a type of dementia), a disease that alters brain function.

• Very rare cases of serious skin reactions called Stevens‑Johnson syndrome, acute generalized exanthematous pustulosis, and erythema multiforme have been reported in patients taking REMINYL^® ER.
• The CONSUMER INFORMATION document has been updated to include this new safety information.
• If you or the person that you are caring for experience(s) any signs of skin reactions (see below) while taking REMINYL^® ER, you should consult a health care professional to be assessed.

Signs of skin reactions may include:

• Stevens‑Johnson syndrome: Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
• Acute generalized exanthematous pustulosis: Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever.
• Erythema multiforme: Rash that may blister with spots that look like small targets.

Janssen Inc. has provided this information to doctors, pharmacists, and long-term care facilities across Canada. For more information, patients should consult their health care professional. The CONSUMER INFORMATION document is available at the Janssen Canada Web site.

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Cases of skin or other serious or unexpected adverse reactions in patients receiving REMINYL^® ER should be reported to Janssen Inc. or Health Canada.

Drug Safety Department
Janssen Inc.

19 Green Belt Drive

Toronto, Ontario

M3C 1L9

Or call toll free at 1-866-825-7122

Or email to dsscan@joica.jnj.com

Or fax to 1-866-767-5865

You can report any suspected side effect associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

original signed by

Cathy Lau, Ph.D.

Vice President

Regulatory Affairs and Quality Management