Articles related to PRODUCT RECALL

The FDA notice added that a letter was sent out about the recall. However, it did not include a press release or other specific details.

“Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation.” — Christelle Huguet, PhD, Ipsen

“Use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” — FDA Class II Recall Definition

Use of the affected products may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.

Thrombotic events occurred earlier with Andexxa than usual care (median of 3.5 days vs 16 days). Fifty-three percent of Andexxa-treated patients who experienced a thrombotic event had the event during the first 3 days.

The FDA’s Class II designation indicates that exposure or usage of ‘a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.’