Ocaliva, approved for primary biliary cholangitis, faced FDA warnings and restrictions after postmarket data showed higher risks of liver transplant and death among treated patients.
Ixchiq now has a warning about its use among elderly people with multiple underlying health conditions after postmarketing reports indicated there is a risk of neurologic and cardiac events in people over the age of 60.
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Some vials in two lots of the antibiotic cefazolin are labeled as being penicillin G potassium, which if used could lead to suboptimal outcomes, adverse events, drug interactions and delayed recovery.