Extencilline Import Authorized

To address a months-long shortage of Bicillin^® L-A (penicillin G benzathine) injection, which is the standard treatment for syphilis, the U.S. Food and Drug Administration (FDA) is allowing imports of Extencilline (benzathine benzylpenicillin) from France. A bacterial sexually transmitted infection (STI), syphilis is on the rise in the U.S. — adding about 75,000 adult cases since 2017 to reach nearly 177,000 in 2021. Cases of congenital syphilis, where the mother passes the infection to her baby during pregnancy, more than tripled in the same timeframe to approximately 2,900 and then rose to nearly 3,800 in 2022. To treat it, the Centers for Disease Control and Prevention (CDC) recommends one intramuscular (IM) injection of Bicillin L-A at 2.4 million units for adults and 50,000 units/kg for pediatric patients (up to 2.4 million units). The dose for Extencilline also is one IM injection at similar dosages. Due to the shortage, Bicillin L-A injections presently are being reserved for pregnant women and babies who need treatment. According to guidelines from the World Health Organization (WHO), nonpregnant adults who test positive for syphilis and their sexual partners may be treated with either of two other antibiotics — 100mg of oral doxycycline twice a day for 14 days or ceftriaxone injection once a day for 10 to 15 days — instead of penicillin. Pfizer, the manufacturer of Bicillin L-A, is increasing production with a return to adequate supplies projected in the second quarter of 2024. Extencilline’s information for prescribers is here.

MedWatch Update

Glucagon-Like Peptide-1 Receptor Agonists

In response to reports of possibly severe mental health side effects associated with using glucagon-like peptide-1 (GLP-1) receptor agonists, the FDA issued a safety communication on Jan. 11, 2024. The therapy class includes some drugs, such as Ozempic^® (semaglutide) injection, that treat type 2 diabetes, and others, such as Zepbound^™ (tirzepatide) injection that is used for weight loss. Despite some evidence that individuals using the drugs might be more likely to think about or even attempt suicide, the FDA has not found substantial information to support the claims. While their investigation continues, patients are advised to keep using their prescribed medications but to be alert for depression, drastic mood changes, or suicidal thoughts. Any unusual side effects should be reported to the patient’s healthcare provider. More information is in the FDA’s notice.