Amid an ongoing shortage of first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker
Laboratoires Delbert, a Paris-based company, stated in a letter that it is collaborating with the FDA to temporarily import 3.5 million units of Extencilline, a medication that is not authorized in the US. The FDA gave the move its approval on Wednesday.
Since mid-2023, there has been a shortage of Bicillin, a long-acting injectable penicillin manufactured by Pfizer that is comparable to Extencilline, in the United States. It is the sole approved treatment for pregnant women to stop it from spreading from mother to child and the preferred course of action for adults with it. Applauding the FDA’s action was the National Coalition of STD Directors.
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“During the country’s it crisis, the delays in treatment that women have faced due to the shortage have put them and their families at grave risk,” executive director David Harvey stated in a statement. “We have been asking the administration to do everything within their power to address the Bicillin L-A shortage and to give communities the resources they need to treat patients and address this public health crisis, and today they have taken meaningful action on that request.” “We hope that this is a first step toward a resolution to this shortage and that the FDA and HHS [Department of Health and Human Services] will keep taking action to guarantee that it is never transmitted to communities.”
As it cases increased nationwide in October, the coalition joined dozens of other public health organizations in pressuring the Biden administration to address the Bicillin shortage, CNN reported. The second quarter of 2024 should see an improvement in the supply issue, according to the FDA’s medicine shortages database.
According to data from the U.S. Centers for Disease Control and Prevention, the number of syphilis cases climbed by around 74% between 2017 and 2021, while the number of it infections in neonates increased by more than 203%. Babies can have severe, incapacitating, or even deadly syphilis. Almost always, a single course of penicillin taken at least one month prior to delivery keeps infected moms from infecting their unborn children.
What is syphilis?
Without treatment, syphilis is a sexually transmitted infection (STI) that can lead to major health issues. There are four stages of infection development: primary, secondary, latent, and tertiary. Signs and symptoms can vary depending on the stage.
How is syphilis spread?
You can obtain syphilis by direct contact with a syphilis sore during vaginal, anal, or oral intercourse.
An unborn child can contract syphilis from a mother who has the disease.
Syphilis cannot be contracted via unintentional contact with items like:
restroom seats, hot tubs, baths, swimming pools, sharing clothes, or dining utensils
I’m pregnant. How does syphilis affect my baby?
You can infect your unborn child with syphilis if you are carrying the virus while you are pregnant. A baby born with a low birth weight may have syphilis. It may increase your risk of having a stillborn baby, a baby that is born dead, or of giving birth too soon. You should be tested for syphilis at least once while you are pregnant in order to safeguard your unborn child. If you test positive, start treatment as soon as possible.
A newborn with syphilis may not exhibit any signs or symptoms of illness. But in a matter of weeks, the infant can experience severe issues if treatment is not given promptly. These infants may experience health issues like cataracts, hearing loss, or seizures, as well as perhaps pass away.
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