JAMP Pharma Corporation is recalling its digoxin tablets because some bottles may contain an incorrect dose, Health Canada announced in an advisory.
The drug-maker said its 0.0625 and 0.125 mg digoxin tablets with certain lot and expiry dates may weigh more or less than they should while looking normal-sized.
Digoxin is a prescription drug used by children and adults to treat mild to moderate congestive heart failure. It can also be used to treat a fast or irregular heartbeat.
“Digoxin is a drug where small differences in dose or blood concentration can lead to very serious side-effects,” Health Canada said on Friday.
Therefore, the agency advised, “it is essential that patients taking an affected JAMP product return it to the pharmacy as soon as possible for replacement.”
People who take this medication should:
- Speak with your pharmacist as soon as possible. Your pharmacist will check if your product is affected and provide a replacement if needed. It may not be possible to know if you are getting the correct dose of digoxin by looking at the tablets. Overweight or underweight tablets may look like normal-sized tablets.
- Continue taking your JAMP 0.0625 or 0.125 mg digoxin tablets until you speak with your pharmacist, as digoxin is an important drug when you have a heart condition.
- Contact a health-care professional immediately if you or someone you are caring for experience serious side-effects related to an overdose of digoxin or reduced efficacy of therapy.
Signs and symptoms of a digoxin overdose may include nausea, vomiting, decreased appetite, diarrhea, confusion, seizures, hallucinations, vision effects (seeing light “halos” around objects, or green or yellow vision), fatigue, irregular heartbeats and an abnormally fast or slow heartbeat.
In cases of severe overdose, heart-related effects could be life threatening. Children, people over the age of 65 and those who have an electrolyte or thyroid disorder may be at a higher risk of harmful effects, the regulator said.
Taking a lower dose of digoxin could reduce its effectiveness and lead to a worsening of the patient’s condition.
Health Canada said it is monitoring the company’s recall.