Methylphenidate Products - Risk of Priapism

Starting date:
April 21, 2015
Posting date:
April 21, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-53011

Audience

Consumers, caregivers and healthcare professionals working in the following settings: psychiatrists, pediatricians, family medicine and general practitioners, emergency physicians, urologists, and pharmacists.

Key messages

  • Prolonged and painful erections (called priapism) have been very rarely reported in patients, including children, taking methylphenidate products.
  • Priapism is a very rare condition that has been reported during treatment with methylphenidate products, after increasing the dose, or stopping the product even for a short period of time. The prescribing information for methylphenidate products has been updated to include this information.
  • Patients who develop priapism should seek immediate medical attention to prevent potential long-term effects on the penis.

        

Issue

The manufacturers of methylphenidate products, in consultation with Health Canada, would like to inform healthcare professionals, parents/caregivers and patients that reports of priapism have been received from the worldwide and Canadian experience.

Drugs can be a cause of priapism.  Priapism has been reported very rarely in patients treated with methylphenidate products even though they are frequently prescribed. From January 1, 1965 to December 31, 2014, 2 cases of suspected priapism in association with methylphenidate products were reported in Canada.

Priapism is considered a medical emergency. For this reason, it is important that patients, parents/caregivers and healthcare professionals be aware of this rare risk of priapism and seek immediate medical attention for priapism to prevent potential long-term effects on the penis.

Products affected

  • BIPHENTIN® (methylphenidate hydrochloride controlled release capsules)
  • CONCERTA® (methylphenidate hydrochloride, extended-release tablets)
  • RITALIN® (methylphenidate hydrochloride)
  • RITALIN® SR (methylphenidate hydrochloride extended release tablets)
  • All generic versions of methylphenidate hydrochloride

Background information

Methylphenidate products are among the medicines that can be used to treat Attention Deficit Hyperactivity Disorder (ADHD). While the condition is common in childhood, ADHD can continue through adolescence and adulthood.  RITALIN® and RITALIN® SR are also indicated for the treatment of narcolepsy, a disorder affecting control of sleep-wake cycles.

Priapism occurs when blood in the penis becomes trapped, leading to an abnormally prolonged (greater than 4 hours) and sometimes painful erection.  Priapism is considered a medical emergency. Immediate medical attention is recommended to prevent potential long-term effects on the penis.

Priapism can occur at any age.  Identifying the condition in children may be more difficult.  Younger patients, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs.

The prescribing information for methylphenidate products has been updated to include information on priapism.

Who is affected

Information for consumers

If you have or if you notice that your child has symptoms of prolonged (greater than 4 hours in duration) and/or painful erections, it is recommended to seek immediate medical attention in order to prevent potential long-term effects on the penis.

Patients and parents/caregivers should discuss with their healthcare professional if they need further information or have questions about methylphenidate therapy. 

Additional Information about BIPHENTIN® is provided in Part III:  Consumer Information section of BIPHENTIN® Product Monograph.

Additional Information about CONCERTA® is provided in Part III: Consumer Information section of CONCERTA® Product Monograph.

Additional Information about RITALIN® and RITALIN® SR is provided in Part III: Consumer Information section of RITALIN® and RITALIN® SR Product Monograph.

Information for health care professionals

Physicians are advised to talk to patients and parents/caregivers about the symptoms and risk of priapism and about the need for immediate medical attention should it occur.

For full prescribing information consult the Product Monographs as follows:

Action taken by Health Canada

The prescribing information, called Product Monographs, for BIPHENTIN®, CONCERTA®, RITALIN® and RITALIN® SR have been updated with this new safety information.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of priapism or other serious or unexpected side effects in patients receiving methylphenidate products should be reported to the manufacturers of those products or Health Canada.

Contact information for manufacturer of BIPHENTIN®
Drug Safety Group
Purdue Pharma
575 Granite Court
Pickering, ON
L1W 3W8
Or call toll free at 1-800-387-4501 or (905) 420-4955
Or email to productinfo@purdue.ca
Or fax to (905) 420-6342 

Contact information for manufacturer of CONCERTA®
Drug Safety Department
Janssen Inc.
19 Green Belt Drive
Toronto, ON
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

Contact information for manufacturer of RITALIN® and RITALIN® SR
Novartis Pharma Canada Inc.
385 Bouchard Blvd.,
Dorval, (QC) H9S 1A9
Or call toll free at: 1-800-363-8883 (Medical Information)
http://www.novartis.ca/en/util/contact_product.shtml

For change of address, fax number or transmission difficulties regarding this notification please email info@ptm-health.com or fax 1-888-780-4268.

You can report any suspected adverse reactions 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
Janssen Inc.
 
Jean Godin, M.D.,
Vice-President and Chief Scientific Officer
Novartis Pharmaceuticals Canada Inc.
 
John Eisenhoffer, M.D.,
Director
Pharmacovigilance & Medical Liaison
Purdue Pharma Inc.

BIPHENTIN® is a registered trademark of Purdue Pharma.
CONCERTA® An ALZA OROS® Technology Product, All trademarks used under license.
RITALIN® is a registered trademark.