Important information on JAMP Spironolactone 25 mg Tablets: Possible oversized tablets

Dear Pharmacist,

This communication is to inform you that certain bottles of JAMP Spironolactone 25 mg tablets, from lot numbers AT250543A and AT250544A, may contain tablets that are thicker (see image below).

This is not a recall communication, please do not return the JAMP Spironolactone 25 mg bottles that you currently have in stock as the product is in Tier 3 drug shortage. A Tier 3 drug shortage is the most critical level, where a medically necessary drug has little or no alternative and the shortage could seriously impact patient care and the healthcare system. Patients should continue taking their dispensed medication. Health Canada has been informed of this situation.

JAMP Spironolactone 25 mg tablet is a prescription drug used in adults for primary hyperaldosteronism, essential hypertension, hypokalemia and edematous conditions such as congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites and nephrotic syndrome.

Taking an oversized tablet could result in an unintended higher dose, which may increase the risk of adverse health consequences.

Spironolactone is not a narrow therapeutic index drug. Signs and symptoms of overdose are generally mild in nature and may include nausea and vomiting, and much more rarely drowsiness, dizziness, mental confusion, diarrhea, or a maculopapular or erythematous rash. Hyperkalemia may be exacerbated following spironolactone overdosing. The dose range recommended to treat hypokalemia is of 25 to 100 mg per day.

However, conditions treated with spironolactone can be severe and treatment interruption could yield greater risk than potential symptoms from an overdose from a single tablet.

Products affected

Information for health care professionals
This product is dispensed exclusively by pharmacists to patients. Pharmacists should check each tablet from bottles of JAMP Spironolactone 25 mg for these lots before dispensing and report any unusual tablet to JAMP Pharma Corporation. Patients should continue to take their JAMP Spironolactone 25 mg tablets.

JAMP Pharma apologizes for this situation and is working on correcting this issue in a timely manner.

Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving JAMP Spironolactone 25 mg tablets should be reported to either JAMP Pharma Corporation or Health Canada.

JAMP Pharma Corporation
1310 Nobel, Boucherville, QC J4B 5H3
Phone : 1-866-399-9091, option 2
Email : medinfo@jamppharma.com
To correct your mailing address or fax number, contact JAMP Pharma Corporation.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by: Calling toll-free at 1-866-234-2345; or Visiting MedEffect Canada’s Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax.

Danny Germain
Vice President, Scientific Affairs
JAMP Pharma Corporation

JAMP Spironolactone 25 mg tablets affected by the oversize issue.