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.
Mylan-Nitro Sublingual Spray
RHO-Nitro Pump Sprayer
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:
get only 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 want 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.
Original expiry date (printed)
Extended expiration date
Mylan-Nitro sublingual spray (DIN: 02243588)
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
Published by: Health Canada
Also available in French
SOURCE Health Canada
View original content: http://www.newswire.ca/en/releases/archive/March2023/17/c9936.html