Amid Shortage of Bicillin, FDA to Import Another Syphilis Drug

Follow Drugslib on

Medically reviewed by Drugs.com.

By Physician’s Briefing Staff HealthDay Reporter

THURSDAY, Jan. 11, 2024 -- The U.S. Food and Drug Administration will allow the importation of Extencilline from a French drugmaker amid the ongoing shortage of the first-line treatment for syphilis (Bicillin) in the United States.

In a letter from Laboratoires Delbert, the Paris-based company said it is working with the FDA to temporarily import 3.5 million units of Extencilline, which is not approved in the United States. The move was approved by the FDA on Wednesday.

Bicillin, a long-acting injectable form of penicillin made by Pfizer that is similar to Extencilline, has been in short supply in the United States since the middle of 2023. It is the recommended treatment for syphilis in adults, and it is the only recommended treatment for pregnant women to prevent syphilis passing from mother to newborn.

The National Coalition of STD Directors applauded the FDA move. "The delays in treatment that women have faced because of the shortage has placed them and their families at grave risk during the nation's syphilis crisis," executive director David Harvey said in a statement. "We hope this is the first step toward seeing a resolution to this shortage, and that HHS [U.S. Department of Health and Human Services] and FDA will continue to take steps to ensure that communities never experience a syphilis treatment shortage again."

In October, the coalition joined dozens of other public health groups in urging the Biden administration to address the Bicillin shortage as syphilis cases jumped across the country, CNN reported. The FDA drug shortages database says the supply problem should ease in the second quarter of 2024.

Syphilis cases have jumped about 74 percent between 2017 and 2021, while cases of syphilis in newborns increased more than 203 percent, according to data from the U.S. Centers for Disease Control and Prevention.

CNN Article

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2024-01-12 06:15

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords