Vigabatrin Recall Issued for One Lot of Seizure Medication

One particular lot of vigabatrin for oral solution US pharmacopeia (USP) 500 mg designated NB301030 has been recalled by InvaGen Pharmaceuticals (Hauppauge, NY)), a subsidiary of Cipla USA (Warren, NJ). Vigabatrin is indicated to treat refractory complex partial seizures as an adjunctive therapy in people aged 2 years and older. The recall was issued due to a seal integrity issue that may cause powder to leak from the pouch.

In a MedWatch bulletin communication, the Food and Drug Administration (FDA) explained that powder leakage resulting from an improper seal may cause underdosing as the medication content inside the pouch might not match the label. Underdosing of vigabatrin poses a risk for serious adverse events (AEs), including intoxication and breakthrough seizures.

According to the FDA, “For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures requiring immediate emergency room treatment.”

Infants and young children are primarily at risk of AEs resulting from underdosing due to seal integrity issues.

The FDA encourages health care providers and patients to report AEs to the MedWatch Safety Information and Adverse Event Reporting Program.