On July 12, 2021, the FDA added a warning to the Fact Sheet for the Johnson & Johnson (Janssen) adenovirus-based COVID-19 vaccine about an increased risk of Guillain-Barré syndrome (GBS) following administration of the product.1

The warning is based on 100 cases of GBS that were reported to the Vaccine Adverse Events Reporting System (VAERS) following administration of the Johnson & Johnson vaccine. Most of the cases occurred within 42 days of vaccination; 95 of the 100 persons who developed GBS required hospitalization, and 1 died. About 12.5 million doses of the Johnson & Johnson vaccine had been administered at the time the warning was issued.Continue reading

Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist ... Continue reading