Essure (Bayer) is the only nonsurgical, permanent contraceptive available in the US. The coil-like devices are placed hysteroscopically in both fallopian tubes and, after several months, scar tissue causes tubal occlusion.1 In 2016, the FDA required Bayer to revise the device's labeling to include a patient decision checklist and a boxed warning about the risks of uterine and fallopian tube perforation, migration of the device to the abdominal or pelvic cavity, persistent pain, and hypersensitivity reactions. Some women were apparently not being informed of these risks before implantation of...

The FDA has withdrawn its Emergency Use Authorization (EUA) of the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab (LY-CoV1404 – Lilly) for treatment of COVID-19. Bebtelovimab is not expected to retain activity against the Omicron variants BQ.1 and BQ.1.1, which currently cause the majority of COVID-19 cases in all regions of the US.

The American Congress of Obstetricians and Gynecologists (ACOG) has announced a new recommendation for antibiotic prophylaxis during cesarean delivery.1 Currently most women receive a single dose of prophylactic antibiotics after the umbilical cord has been clamped to prevent antibiotics from crossing over to the newborn. The new recommendation is for women giving birth by cesarean section to routinely receive antibiotics within one hour before the start of surgery. In the case of an emergency cesarean delivery, prophylaxis should be started as soon as possible.Recent studies have found a...

Use of proton pump inhibitors (PPIs) to treat gastroesophageal reflux disease (GERD) has been associated with an increase in the risk of fractures. The FDA now requires that the labels of all prescription PPIs include a warning about an increased risk of fractures with long-term use.

An outbreak of mumps has occurred among students at Fordham University in New York. All of those who developed mumps had been vaccinated against the disease.

The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK inhibitor to be approved for this indication; ibrutinib (Imbruvica) was approved in 2013.Ibrutinib inhibits other kinases in addition to BTK and has been associated with severe adverse effects, particularly atrial fibrillation, infection, rash, and bleeding, that may be related to inhibition of kinases other than BTK.1 Acalabrutinib is a more selective BTK inhibitor than ibrutinib; whether...

The FDA has approved the anti-CD30 antibody-drug conjugate brentuximab vedotin (Adcetris – Seattle Genetics) for use in combination with chemotherapy for IV treatment of adults with previously untreated stage 3 or 4 classical Hodgkin's lymphoma (cHL). Adcetris was approved earlier for consolidation treatment of cHL and for treatment of relapsed or refractory cHL, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.FDA approval for the new indication was based on the results of an open-label trial (ECHELON-1) in 1334 patients with previously untreated stage 3 or 4 cHL.1...

On May 10, 2021, the FDA expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine to include adolescents 12-15 years old.1The vaccine has been authorized for use in persons ≥16 years old since December 2020.

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.

A live attenuated varicella vaccine (Varivax - Merck) has been approved for marketing by the US Food and Drug Administration. The Oka/Merck strain used in the vaccine is attenuated by passage in human and embryonic guinea pig cell cultures.