Astellas Pharma recalls vital transplant drugs Prograf and Astagraf XL due to potentially empty capsules, risking organ rejection and fatal consequences for patients.
You don’t hate Big Pharma enough.
At a Glance
- Prograf and Astagraf XL, crucial drugs for transplant patients, recalled due to potentially empty capsules
- Recall affects specific lots of 0.5 mg capsules with expiration dates in March 2026
- Empty capsules could lead to organ rejection, particularly dangerous for heart transplant recipients
- Patients advised to contact their medical professionals and verify medication batches
- No adverse events reported yet, but vigilance is crucial
Critical Medication Recall Threatens Transplant Patients
Astellas Pharma has issued an urgent nationwide recall of two essential medications used by organ transplant recipients. The recall affects specific lots of Prograf and Astagraf XL, both containing tacrolimus, a drug crucial for preventing organ rejection in patients who have undergone heart, liver, kidney, or lung transplants. The recall was initiated after reports emerged of potentially empty capsules in these medication bottles, posing a severe risk to patient health.
The recall specifically targets Prograf 0.5 mg capsules from Lot No. 0E3353D in 100-count bottles and Astagraf XL 0.5 mg capsules from Lot No. 0R3092A in 30-count bottles. Both lots have expiration dates in March 2026. Astellas Pharma has emphasized that other formulations or doses of these medications are not affected by this recall, and there is sufficient supply available to replace the recalled lots.
Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules https://t.co/5JeQEKcp1f pic.twitter.com/R9a3kLnwgw
— U.S. FDA Recalls (@FDArecalls) December 25, 2024
Potential Fatal Consequences for Transplant Recipients
The gravity of this recall cannot be overstated, particularly for heart transplant patients. Astellas Pharma’s risk statement underscores the potentially fatal consequences of this medication failure. “In the case of life sustaining organ transplants such as a heart transplant (for which there is no permanent substitute such as hemodialysis in the case of a failed kidney transplant) if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal,” Astellas stated.
The recall highlights concerns about manufacturing oversight and quality control in the pharmaceutical industry. A missed dose or ineffective capsule can trigger an immune response, risking organ failure. Patients experiencing symptoms of organ rejection are urged to seek immediate medical attention.
Actions for Patients and Healthcare Providers
Patients in possession of the recalled medication are strongly advised to contact their prescribing medical professional immediately. It is crucial not to discontinue the medication without professional guidance, as this could also lead to organ rejection. Healthcare providers and patients can contact Astellas at 800-727-7003 for inquiries related to this recall.
Wholesalers with questions about the recall can call 877-575-3437. Any medical issues related to these drugs should be reported to a medical professional and the FDA’s MedWatch program. This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration, emphasizing the seriousness of the situation.
