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Astellas Pharma has issued an urgent recall of two critical immune-suppressing medications due to potentially empty capsules, raising concerns for organ transplant patients.

At a Glance

  • Prograf and Astagraf XL, crucial post-transplant medications, are being recalled
  • The recall affects specific lots due to the risk of empty capsules
  • Empty capsules could lead to organ rejection, potentially fatal in heart transplants
  • Patients are advised to check their medication lots and consult their healthcare providers

Critical Medications Recalled

Astellas Pharma has initiated a voluntary nationwide recall of two vital immune-suppressing medications, Prograf and Astagraf XL. These drugs are essential for preventing organ rejection in transplant patients, with Prograf used after heart, liver, kidney, or lung transplants, and Astagraf XL specifically for kidney transplants. The recall stems from the discovery of potentially empty capsules in certain production lots, which could have severe consequences for patients relying on these medications.

The recall affects specific lots: Prograf 0.5 mg in 100-count bottles (lot No. 0E3353D) and Astagraf XL 0.5 mg in 30-count bottles (lot No. 0R3092A), both with an expiration date of March 2026. This action is being conducted with the FDA’s knowledge and highlights the critical nature of quality control in pharmaceutical manufacturing.

Potential Risks and Patient Advice

The presence of empty capsules in these medications poses a significant risk to transplant recipients. Astellas Pharma has issued a stark warning about the potential consequences, particularly for heart transplant patients.

“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 in their risk statement.

Patients who are currently using these medications are strongly advised to check their medication lots against those listed in the recall. If their medication is affected, they should immediately contact their prescribing medical professional for guidance. It’s crucial not to discontinue the medication without professional medical advice, as this could also lead to serious health risks.

Recall Response and Resources

Astellas Pharma is taking proactive steps to address this issue. The company is notifying customers and arranging for product returns. They have emphasized that other formulations or doses of these medications are not impacted, and there is sufficient supply to replace the recalled lots.

For those seeking more information, Astellas has set up dedicated lines to handle inquiries. Wholesalers with questions about the recall can call 877-575-3437, while patients and doctors can reach out to Astellas at 800-727-7003 for recall-related concerns. Additionally, any medical issues potentially related to these drugs should be reported to a healthcare professional and the FDA’s MedWatch program to ensure proper monitoring and response.

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