FDA has concerns with Bristol transplant drug
The Food and Drug Administration says, “an organ transplant drug from Bristol-Myers Squibb improves kidney function, but the agency has concerns about potentially fatal side effects.” (AP Washington, 2/25). Although Bristol has asked the FDA to approve its drug Belatacept for patients undergoing a kidney transplant, the FDA is concerned that the drug suppresses the body's immune system to avoid organ rejection.
In online documentation, the FDA noted that although more patients taking Belatacept had a higher two year survival rate than those taking other drugs, it also noticed higher rates of severe kidney rejection and neurological disease.
As the next step, the FDA wants its outside advisers to vote on the drug's safety and effectiveness, which is set to occur next week. As a medical malpractice lawyer in Chicago, I have seen many incidents of fatal side effects, and am hopeful the FDA will act quickly and decisively in determining the safety of Belatacept.
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