His Kidney Failed. Hell Never Know if a Transplant Drug From a Banned Factory Was to Blame.

Published: Monday, June 23, 2025 at 9:00 am

Tacrolimus Concerns: FDA Exemptions Raise Questions About Drug Safety

A recent investigation by ProPublica has raised concerns about the safety of tacrolimus, a crucial immunosuppressant drug used to prevent organ rejection in transplant patients. The investigation focuses on tacrolimus manufactured by Intas Pharmaceuticals, a company whose factory in western India has faced repeated scrutiny from the Food and Drug Administration (FDA).

The FDA has inspected the Intas factory at least eight times since 2015, uncovering issues such as manipulated drug-testing records. Despite these findings, the FDA has granted exemptions, allowing certain Intas drugs, including tacrolimus, to continue being imported into the United States. This practice, aimed at preventing drug shortages, has been largely hidden from the public.

The investigation highlights the case of Joe DeMayo, a kidney transplant recipient who took Intas tacrolimus for two years. His donated kidney failed earlier than expected, prompting questions about the medication's effectiveness. Tests conducted by an independent lab, Valisure, on DeMayo's unused capsules revealed that some pills contained less of the key ingredient than required, and the capsules dissolved too quickly, potentially leading to adverse effects.

The FDA's own studies have also raised concerns, noting that the Intas generic could create toxins in the body, potentially causing kidney damage. Despite these findings, the FDA continued to exempt tacrolimus from the import ban. Intas, in a statement, maintains that its tacrolimus is safe and effective and that it has taken steps to address the FDA's concerns.

BNN's Perspective:

This situation underscores the critical need for robust oversight of drug manufacturing and import practices. While the FDA's efforts to prevent drug shortages are understandable, the potential risks associated with allowing drugs from factories with known quality control issues into the U.S. market are significant. The agency must prioritize patient safety by ensuring rigorous testing and transparency in its exemption processes.

Keywords: tacrolimus, FDA, Intas Pharmaceuticals, drug safety, organ rejection, kidney transplant, generic drugs, import ban, drug shortages, Valisure, immunosuppressant, medication, health, healthcare, patient safety, drug manufacturing, drug testing, contamination, underdosing, rapid dissolution

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