By Daily Mail (U.S.) | Created at 2024-12-26 06:11:38 | Updated at 2024-12-26 18:37:26
12 hours ago
Pharmaceutical giant Astellas Pharma has issued an urgent recall for two of its critical drugs: Prograf and Astagraf XL - which could have fatal consequences for patients recovering from life-saving organ transplants.
Both medications are immunosuppressives prescribed to help transplant recipients avoid organ rejection, but shockingly, some of the capsules may be completely empty.
The ineffective pills would leave patients unprotected and at risk of developing life-threatening complications such as organ rejection.
The discovery of empty capsules raises alarming questions about manufacturing oversight and quality control, especially for medications where even one missed dose could mean catastrophic consequences.
The recall centers on Prograf 0.5 mg capsules (lot No. 0E3353D) and Astagraf XL 0.5 mg capsules (lot No. 0R3092A), both of which carry the expiration date March 2026.
Prograf is used after heart, liver, kidney, or lung transplants, while Astagraf XL is prescribed specifically for kidney transplants.
'In the case of life-sustaining organ transplants such as a heart transplant,' Astellas acknowledged in its recall notice, 'if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal.'
For transplant recipients, the drugs are the cornerstone of their survival.
Pharmaceutical giant Astellas Pharma has issued an urgent recall for two of its critical drugs: Prograf and Astagraf XL - which may have been sent out with empty capsules
Astellas Pharma’s Prograf is prescribed after heart, liver, kidney or lung transplants
Astellas’ Astagraf XL is usually prescribed after kidney transplants
Immunosuppressive medications like Prograf and Astagraf XL prevent the body from rejecting transplanted organs, tissues, or cells.
A missed dose - or in this case, unknowingly taking an ineffective empty capsule - can disrupt this delicate balance, triggering an immune response that could lead to organ failure.
The stakes are particularly high for heart transplant patients, as there is no long-term substitute treatment like dialysis for kidney failure.
Astellas Pharma, a global leader in the development of transplantation medications, has long been a trusted name in the pharmaceutical world.
Not all Prograf and Astagraf XL products are affected, but the recall includes the following:
- Prograf 0.5 mg capsules: Lot No. 0E3353D, 100-count bottles
- Astagraf XL 0.5 mg capsules: Lot No. 0R3092A, 30-count bottles
Astellas Pharma, a global leader in the development of transplantation medications, has long been a trusted name in the pharmaceutical world. Pictured, it's Tokyo, Japan headquarters
Patients are urged to check their medication immediately and consult their prescribing healthcare providers if they suspect they have a recalled product.
Wholesalers and pharmacies holding these products have been instructed to contact Astellas directly at 877-575-3437 for guidance.
Afterward, they should report the incident to the FDA's MedWatch program at 800-332-1088.
For patients experiencing potential symptoms of organ rejection - such as fever, pain near the transplanted organ, or sudden changes in health - it is critical to seek medical attention immediately.
