NDMA is classified as a probable human carcinogen. This means that long-term exposure to a level above what is considered safe may increase the risk of cancer. Health Canada is advising that there is no immediate risk in continuing to take the recalled APO-Amitriptyline or Elavil (amitriptyline) since the potential risk of cancer is with long-term exposure (every day for 70 years) to NDMA that exceeds safe levels.
Health Canada maintains a list of recalled amitriptyline drugs affected by this issue. Please see the full advisory for more information, including more on the risk and what patients should do.
| Company | Product | Strength | DIN | Lot | Expiry |
| AA Pharma Inc. | Elavil
(Amitriptyline Hydrochloride Tablets USP) |
10 mg | 00335053 | PY1829 | 12/2023 |
| AA Pharma Inc. | Elavil (Amitriptyline Hydrochloride Tablets USP) |
10 mg | 00335053 | PY1830 | 12/2023 |
| Apotex Inc. | APO-Amitriptyline
(Amitriptyline Hydrochloride Tablets USP) |
10 mg | 02403137 | PY1832 | 12/2023 |
WHAT TO TAKE AWAY FROM THIS ARTICLE:
- Health Canada is advising that there is no immediate risk in continuing to take the recalled APO-Amitriptyline or Elavil (amitriptyline) since the potential risk of cancer is with long-term exposure (every day for 70 years) to NDMA that exceeds safe levels.
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