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Health professional risk communication

Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose - Additional Information on the Recall - For Health Professionals

Starting date:
September 22, 2014
Posting date:
September 22, 2014
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-41505

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose

September 22, 2014

Dear Health Care Professional,

Subject: Some Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose (DIN: 02243588) canisters may be missing dip tubes

Mylan Pharmaceuticals ULC, in consultation with Health Canada, wants to inform you of a manufacturing issue which could cause some of Mylan’s Nitro-Sublingual Spray canisters to stop delivering medication, due to a missing dip tube in the pump valve assembly. This could, in turn, lead to a patient not receiving a dose of medicine when needed. Mylan has determined that the potential frequency of the missing dip tubes is very low, and no such issue has been reported by consumers to date.

An initial decision was made to recall this product due to the possibility of a failed dose and the potential risk to the patient. Subsequent to the decision to recall all lots of the product and the posting of a Public Advisory on the Health Canada website advising of the recall, Mylan became aware of additional information concerning the potential for a shortage of nitro sublingual spray.  While this continues to remain a recall situation, in view of the potential for a drug shortage, and to provide patients with ongoing access to a medically necessary product, Mylan Pharmaceuticals ULC has proposed the following steps as a short-term interim approach to meet patients’ needs. Based on the information received to date, Health Canada accepted this as an interim strategy while Mylan urgently investigates other options to stabilize supply of Mylan-Nitro Sublingual Spray.

  • An affected spray canister with a missing dip tube will only reliably deliver about 70-75 sprays rather than the usual 200. There is no obvious way to identify if a canister is affected. A new canister can be safely used for 70-75 sprays.
  • As an immediate precautionary measure and until further notification patients who have been using Mylan-Nitro Sublingual Spray should be contacted and provided with two new replacement canisters. They should also be advised to renew their prescription about 3 times more often than usual, or as they approach 70 sprays with a single canister, whichever comes first.
  • Patients should be reminded to always have a spare spray canister readily available for use in case their current canister runs out of medication or fails to work properly.
  • Healthcare professionals may wish to consider available alternative therapies for patients currently receiving nitro spray or when initiating treatment for new patients.

Mylan Pharmaceuticals ULC continues to work on resolving this issue as quickly as possible and resuming regular product supply. Health Canada will continue to work with the company and monitor the situation to help ensure that patients and healthcare professionals are informed. Mylan Pharmaceuticals ULC will issue a new communication letter to inform you immediately when the situation has been fully resolved. Once the supply has been stabilized and unaffected product becomes available, remaining product from the affected lots will be removed from the market.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious adverse reactions, or unexpected adverse reactions in patients receiving Mylan-Nitro Sublingual Spray 0.4 mg per metered dose should be reported to Mylan Pharmaceuticals ULC or Health Canada.

Mylan Pharmaceuticals ULC
85 Advance Road, Etobicoke, ON
M8Z 2S6
Mylan ULC Customer Relations
Phone: 1-800-575-1379
Fax: 1-855-236-2990
E-mail: customerservice@mylan.ca

To correct your mailing address or fax number, contact Mylan Pharmaceuticals ULC.

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

For other health product inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636

Sincerely,

original signed by

Anca Schmidt
Senior Director, Quality
Mylan Pharmaceuticals ULC