UK petitions FDA for recall of injectable medication after finding impurities
Researchers at the University of Kentucky are petitioning the Food and Drug Administration to recall batches of an injectable drug after quality testing found impurities and “lower than acceptable levels” of the active ingredient.
Quality tests performed in the UK HealthCare Pharmacy on the injectable form of the drug acetazolamide found four times the acceptable amount of impurities allowed by the FDA, the university announced in a release Thursday. Acetazolamide is a generic medication commonly used to treat glaucoma, epilepsy, altitude sickness and fluid retention.
“We are not aware of any unexpected adverse effects in patients administered this FDA-approved drug, but the findings by our Drug Quality Safety team are concerning to us,” said Dr. Mark Newman, UK executive vice president for health affairs, in a statement. “Patient safety is our utmost priority at UK HealthCare and being on the forefront of drug quality and safety is an effort we commend our team for undertaking to assist in top-quality care.”
Newman stressed in the statement that those who have been prescribed medications should not stop taking them. Those with questions should consult their pharmacist.
In August, UK HealthCare researchers tested samples of the drug as part of UK’s new Drug Quality Study which started in 2019. Acetazolomide was one of the first drugs tested in the study, which is being used as a quality control process in partnership with UK HealthCare and the university’s College of Pharmacy. According to the university, UK’s pharmacy is only one of two in the U.S. currently doing quality testing on incoming medications.
The August study found varying amounts of ingredients in vials of the drug, suggesting concerns around the manufacturing process. After those tests, the drug was removed from UK’s pharmacies and the university’s results were confirmed by an independent global researcher, the release stated. The drug only contained 80 to 87 percent of the active pharmaceutical ingredient — lower than national standards.
Other impurities found in the vials are unknown substances, said Philip Almeter, UK HealthCare’s chief pharmacist, and Robert Lodder, a pharmaceutical sciences professor. The unknown substances could be the results of a breakdown of the drug.
On Wednesday, the university filed a petition with the FDA requesting the recall of certain batches of the drug manufactured in India by Mylan Laboratories and manufactured by Hikma in Portugal. According to the release, the petition also asks for investigations of the drug’s manufacturing process and that the FDA notify the public.
“Drug quality in the United States is ensured by maintaining control of the manufacturing process,” said Lodder, in the release. “The fact that the process is producing samples of varying composition indicates that process control is not being maintained.”