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Public Advisory - Shortage of Nitroglycerin Sprays in Canada

OTTAWA, ON, March 17, 2023 /CNW/ -

Summary

Product: Nitroglycerin 0.4 MG/ACT sprays 
Issue: Health products - Supply 
What to do: Speak with your healthcare professional about how best to manage any impact of this shortage. Obtain only the amount you need. Keep expired product and check the table below to determine whether the expiry date of your product has been extended.

Affected products

Company

Product

Mylan

Mylan-Nitro Sublingual Spray

Sandoz

RHO-Nitro Pumpspray

Sanofi

Nitrolingual Pumpspray


Issue

Canada is experiencing a shortage of nitroglycerin 0.4 MG/ACT sprays due to supply issues with the raw materials used to make 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 (chest pain) in people who have 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 is typically used in addition to other medication to treat angina.

Availability of this medication in hospitals and community pharmacies is expected to be limited  during the spring. Health Canada is leading work with provincial and territorial governments, manufacturers and stakeholders across the supply chain and healthcare system, including the Canadian Pharmacists Association, the Canadian Cardiovascular Society and the Heart & Stroke Foundation. Together with its partners, Health Canada is looking at ways to conserve existing supply, expedite resupplies to hospitals and pharmacies, and access foreign-authorized supply or alternatives, where possible.

One way to conserve existing supply is the extension of product expiry dates when manufacturers can provide evidence to support such extensions. Certain extensions have already been granted and Health Canada   is asking people to:

  • only obtain what they need from their pharmacy;
  • keep expired product; and
  • check the chart below to confirm which product(s) can be used beyond their Original (Printed) Expiry Date.

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

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

Products with Approved Extended Expiry Dates

In response to the shortage Health Canada requested that manufacturers determine if certain products could be safely used beyond their printed expiry. Health Canada reviews the information to ensure that the product is safe and will work beyond the printed expiry date. Products with extended expiry dates will be listed below. The chart will be updated as information becomes available.

To determine if a product has an Extended Expiry Date, people should verify whether the Lot Number and Printed Expiry Date on the bottle correspond to any of the lots listed in the chart below. Please see reference image for assistance. People may also wish to seek the assistance of a healthcare professional, such as a pharmacist, to verify. Products should NOT be consumed beyond their Extended Expiry Date listed below.

Product Name

Lot Number

Original (Printed) Expiry Date

Extended Expiry 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 questions or concerns about this shortage, speak to a health care professional, such as your doctor or pharmacist.

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

Any adverse health product event should be reported to Health Canada.

Alert / recall type: Public Advisory
Category: Drugs
Published by: Health Canada

Également disponible en français

SOURCE Health Canada

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

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