BRAVELLE (75 IU urofollitropin for injection, purified) - Recalled lots due to Reduced Therapeutic Effect

Starting date:
October 23, 2015
Posting date:
October 23, 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-55560

Audience

Health Care Professionals involved in Assisted Reproductive Technology Programs (ART):Pharmacists, ART-specialized Obstetricians, and Reproductive Endocrinologists

Key messages

  • Four (4) lots of BRAVELLE™ (75 IU urofollitropin for injection, purified) are being recalled by Ferring Inc. Canada.
  • Decreased follicle stimulating hormone (FSH) potency was observed during stability testing. For the affected lots, the decrease in FSH potency may result in a reduced therapeutic effect.
  • Health care professionals should not use the vials of the affected lots of BRAVELLE™ and should return the product as outlined in the Recall Notice issued by Ferring Inc. Canada.
  • For patients who have not yet started on BRAVELLE™, there are other options for treatment with FSH.

Issue

Ferring Inc. Canada, in consultation with Health Canada, would like to inform health care professionals of a voluntary recall of four (4) lots of BRAVELLE™. The recall is due to reduced potency of the product detected during routine stability testing.

It is unlikely that a reduced therapeutic effect would cause a direct adverse health consequence in the short term. However, there is the potential for unnecessary over-exposure of patients in establishing an effective dose.

If there is a shortage of BRAVELLE, the treating fertility physician should use their discretion and should weigh the benefits and risks of using another product or defer therapy until the supply resumes. For patients who have not yet started on BRAVELLE there are other options for treatment with FSH. FSH products available on the market are not deemed interchangeable.

Products Affected

This voluntary recall applies to the following lots for BRAVELLE™ (75 IU urofollitropin for injection), DIN: 02268140:
LOT EXPIRY DATE
H15940B 10/2015
H15940C 10/2015
K16990B 09/2016
K16990C 09/2016

Background information

BRAVELLE™ in conjunction with human chorionic gonadotropin (hCG) is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression including patients participating in an Assisted Reproductive Technology (ART) program.

During routine stability testing, out of specification analytical results (reduced potency) were obtained for follicle stimulating hormone (FSH) potency on certain lots of BRAVELLE. The out of specification results occurred between 12 to 24 months. Approved shelf-life in Canada is 24 months when stored between 15°C and 25°C and protected from light. As a result, the described quality issue concerns "reduced therapeutic effect" and it is evaluated that the medical consequences for a female patient exposed could be lack of/decreased follicle stimulation (ovulation) with decreased or lack of clinical effect. This is not likely to cause adverse health consequences to the female patients exposed. However, there is the potential for unnecessary over-exposure of patients in establishing an effective dose.

Ferring Inc. Canada is recalling the affected lots and a projected re-stocking date has not yet been determined. The company is investigating the issue to further determine the root cause and will implement necessary corrective and preventive actions.

Who is affected

Information for consumers

Patients with questions or concerns about their BRAVELLE treatment should talk to their health care professional.

Information for health care professionals

Vials of the affected lots should not be used and should be returned as outlined in the Recall Notice issued by Ferring Inc. Canada. If you have not received a recall notice or are uncertain as to what the procedure is, please call Ferring Inc. for assistance at 1-866-384-1314 (Medical Information) or Quality Assurance at 1-800-263-4057 on how to return the product.

Updates on the resupply can be found on the drug shortages website.

Health care professionals are advised to remain vigilant in their follow up with patients who have used the impacted lot. Please inform other health care professionals in your organization of this recall as needed.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect e-Notice email notification system. Health Canada is also monitoring the recall and the implementation of necessary corrective and preventive actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of unusual lack of efficacy in patients receiving BRAVELLE™ should be reported to Ferring Inc. Medical Information or Health Canada.

Ferring Inc. Canada
200 Yorkland Boulevard, Suite 500
Toronto, ON M2J 5C1
Telephone: 1-866-384-1314

To correct your mailing address or fax number, contact Ferring Inc.Canada.

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

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

Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-563

Original signed by

Teodor Burtea, MD
Medical Director,
Ferring Inc., Canada

For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.