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FDA allows import of antibiotic during Bicillin shortage

January 11, 2024

Editor's note: For more coverage of drug, immunization and medical device shortages, visit https://bit.ly/AAPNewsDrugShortages.

The Food and Drug Administration (FDA) is temporarily allowing importation of an antibiotic that can be used to treat syphilis while there is a shortage of Bicillin L-A (penicillin G benzathine injectable suspension).

Extencilline (benzathine benzylpenicillin) is a powder and diluent for reconstituting for injection and is available in strengths of 1.2 million units and 2.4 million units. It can be used in neonates, children, adolescents and adults. The product from Laboratoires Delbert in conjunction with Provepharm Inc. and Direct Success Inc. is marketed in France and manufactured in Italy. It is not FDA approved.

Pfizer sent a letter to customers in June about supply issues impacting Bicillin L-A and Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) prefilled syringes. Some presentations remain in limited supply and others are depleted, according to Pfizer.

Bicillin is used to treat pregnant women with syphilis, which helps protect their babies from the disease. Bicillin also is used to treat babies with congenital syphilis, which has been on the rise.

Ten times as many babies were born with syphilis in 2022 than a decade prior, bringing rates to their highest level in at least 30 years, according to a recent report from the Centers for Disease Control and Prevention (CDC).

There are several differences between the warning and instructional labels for Extencilline and Bicillin L-A that are detailed in a letter from Laboratoires Delbert to health care providers. The two also come in different forms (powder for reconstitution compared to a prefilled syringe). Instructions are available on how to prepare and administer Extencilline.

To place an order, contact Direct Success at Distribution@DSuccess.com or 877-404-3338.

 

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