Public Notice – Shortage of Nitroglycerin Sprays in Canada

OTTAWA (ON), March 17, 2023 /CNW/ –

Summary

Product: Nitroglycerin Sprays 0.4 MG/ACT
Issue: Health Products – Supply
What to do: Discuss with your healthcare professional how best to manage any impact of this shortage. Get only the amount you need. Save the expired product and check the table below to determine if your product’s expiration date has been extended.

Affected products

Business

Product

Mylan

Mylan-Nitro Sublingual Spray

Sandoz

RHO-Nitro Pump Sprayer

Sanofi

Nitrolingual sprayer


Issue

Canada is experiencing a shortage of Nitroglycerin 0.4 MG/ACT sprays due to supply issues with the raw materials used to manufacture the sprays as well as an increase in demand.

Nitroglycerin sublingual spray is applied under the tongue and is used to treat pain during episodes of angina pectoris (chest pain) in people with coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Nitroglycerin spray is a fast-acting medication, used as needed and usually used alongside other medications to treat angina.

The availability of this drug in hospitals and community pharmacies is expected to be limited in the spring. Health Canada leads work with provincial and territorial governments, manufacturers, and supply chain and health system stakeholders, including the Canadian Pharmacists Association, Canadian Cardiovascular Society, and Heart and Stroke Foundation. Working with its partners, Health Canada is looking at ways to retain existing supply, expedite hospital and pharmacy restocking, and access authorized supplies or alternatives overseas, to the extent possible.

One way to retain existing supply is to extend product expiration dates when manufacturers can provide evidence to support such extensions. Some extensions have already been granted and Health Canada is asking people to:

  • only get what they need from their pharmacy;

  • keep the expired product; And

  • Check the table below to confirm which products can be used beyond their original (printed) expiration date.

Nitroglycerin spray is an important and widely used product. Health Canada recognizes that this shortage is a concern for people who use it to treat angina pain.

Health Canada also assesses the available supply of tablets, which may be a potential alternative for some people.

Products with approved extended expiration dates

In response to the shortage, Health Canada has asked manufacturers to determine if certain products are safe to use past their printed expiration date. Health Canada reviews the information to ensure that the product is safe and will work beyond the printed expiration date. Products with extended expiration dates will be listed below. The table will be updated as information becomes available.

To determine if a product has an extended expiration date, users should check to see if the lot number and expiration date printed on the bottle matches one of the lots listed in the table below. Please see the reference image for help. People may also wish to seek the help of a medical professional, such as a pharmacist, to check. Products should NOT be consumed beyond their extended expiration date listed below.

Product Name

Batch number

Original expiry date (printed)

Extended expiration date

Mylan-Nitro sublingual spray (DIN: 02243588)

9F715

06/2022

06/2023

9F717

06/2022

06/2023

0B847

02/2023

02/2024

0B853

02/2023

02/2024

OF904

06/2023

06/2024

OG910

07/2023

07/2024

0H919

08/2023

08/2024

If you have any questions or concerns about this shortage, speak to a healthcare professional, such as your doctor or pharmacist.

Manufacturers post information about shortages and their expected end date on drugshortagescanada.ca.

Any adverse event related to a health product must be reported to Health Canada.

Alert/Reminder Type: Public consultation
Category: Drugs
Published by: Health Canada

Also available in French

SOURCE Health Canada

Quote

View original content: http://www.newswire.ca/en/releases/archive/March2023/17/c9936.html

Public Notice – Shortage of Nitroglycerin Sprays in Canada

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