OTTAWA, ON, May 10, 2023 /CNW/ -
Product: Nitroglycerin 0.4 MG/ACT sprays and Nitrostat 0.3mg/0.6mg sublingual tablets (added on May 10, 2023)
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 (DIN 02243588) |
Sandoz |
RHO-Nitro Pumpspray (DIN 02238998) |
Sanofi |
Nitrolingual Pumpspray (DIN 02231441) |
BGP Pharma |
Nitrostat Sublingual Tablets 0.3 mg (DIN 00037613) and 0.6 mg (DIN 00037621) - added on May 10, 2023 |
May 10, 2023 – Shortage of Nitroglycerin Tablets
Canada is experiencing a shortage of nitroglycerin tablets due to an increase in demand caused by the nitroglycerin spray shortage. Nitroglycerin tablets are placed under the tongue and are 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).
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.
Original Advisory: March 17, 2023 - Shortage of Nitroglycerin Sprays in Canada
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
Media Enquiries: Health Canada, 613-957-2983, [email protected]; Public Enquiries: 613-957-2991, 1-866 225-0709
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