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  1. Knowledge and News on Women: OWH Blog

Spotlight on Syphilis and Congenital Syphilis

Knowledge and News on Women’s Health (KNOWH) blog from FDA Office of Women’s Health


Sexually Transmitted Infections (STIs) Awareness week, observed annually in April, serves as an opportunity to raise awareness, promote education, and encourage proactive measures to prevent the spread of STIs. Of particular concern this STI Awareness Week is syphilis and congenital syphilis as the number of cases in the U.S. are on the rise. According to a new report from the Centers for Disease Control and Prevention, syphilis cases in the United States increased by nearly 80% between 2018 and 2022, creating a critical public health issue.

OWH_Syphilis graphic

What is syphilis

Syphilis is a sexually transmitted infection that can cause serious health problems if left untreated. It is a bacterial infection that spreads through sexual contact with someone who has the infection. If a person has or gets syphilis during pregnancy, it could lead to congenital syphilis in the infant after birth. Syphilis progresses through stages:

  • The primary stage—painless sore at the site where syphilis entered the body. The sore usually lasts 3 to 6 weeks and heals regardless of whether you receive treatment.
  • If left untreated, syphilis moves on to the secondary stage, symptoms include usually non-itchy skin rashes, fever, sore throat, fatigue. The rash can show up when your primary sore is healing or several weeks after the sore has healed.
  • Without treatment, the infection moves on to the latent stage—a period when there are no visible signs or symptoms of infection, but the infection remains in the body. 
  • In its tertiary stage, syphilis can cause severe complications, including cardiovascular and neurological disorders. Tertiary syphilis is very serious and may occur 10–30 years after the infection began.

Congenital syphilis

Pregnant woman with HCP

When a pregnant person has syphilis, the infection can spread in utero before the child is born. This transmission of syphilis can occur at any stage of pregnancy and can result in serious consequences for the newborn. Congenital syphilis may lead to stillbirth, premature birth, low birth weight, and a range of serious health issues, including bone deformities, brain and nerve problems like blindness or deafness.

The impact of congenital syphilis highlights the importance of prenatal screening and early detection of syphilis in pregnant people. All pregnant people should receive testing for syphilis at their first prenatal visit. People who live in areas with high syphilis rates or who are at risk for getting syphilis during pregnancy should be retested at 28 weeks gestation and at time of delivery. Individuals at risk of getting syphilis during pregnancy include people who use illicit drugs, have other STIs during pregnancy, or have multiple sexual partners or a new partner, and those who have a partner with known STIs.

Prevention and screening

  • The only way to completely avoid syphilis is to not have sexual contact.
  • Consistent and correct use of condoms during sexual activity can reduce the risk of syphilis transmission.
  • Routine screening for syphilis is recommended, especially for people at increased risk, including pregnant people. Ask your health care provider if you need to get screened for syphilis. 
  • Syphilis can be treated with antibiotics. Early detection of syphilis can lead to early treatment to prevent complications and reduce the spread of syphilis. 


Syphilis is curable with antibiotics. A single injection of long-acting Benzathine penicillin G can cure the early stages of syphilis. CDC recommends three doses of long-acting Benzathine penicillin G at weekly intervals for late latent syphilis and later stages of syphilis. Alternative therapies are available for people who have an allergy to penicillin but should not be used during pregnancy. 

Talk with your health care provider about your situation and which treatment option is right for you. 

Treatment will cure the infection and prevent further damage, but it will not repair damage already done. See the CDC’s STI Treatment Guidelines for more information on syphilis treatment.

The FDA has listed penicillin G benzathine injectable suspension products (Bicillin L-A®) on their drug shortage webpage, noting increased demand. In addition, the FDA website includes an expected duration for the shortage. The FDA is exercising enforcement discretion for a temporary importation and use of Extencilline (benzathine benzylpenicillin injection, powder, for suspension) to mitigate the effects of the Bicillin L-A® drug shortage. The FDA is continuing to monitor and to offer any assistance needed with supply.

FDA’s role 

The FDA Office of Women’s Health is committed to contributing to the effort to address the syphilis epidemic and to help reduce the rate of syphilis and congenital syphilis by raising awareness about the importance of regular STI screenings, treatment if infected, and proactive measures to reduce the risk of getting syphilis, especially for women and during pregnancy. 

The FDA plays an important role in addressing the challenges posed by syphilis and congenital syphilis including ensuring the accuracy and reliability of tests for syphilis screening and diagnosis. The FDA evaluates and approves diagnostic tests to ensure their safety and effectiveness in detecting syphilis infection promptly, including approval of the first rapid test system for combined detection of syphilis and human immunodeficiency virus (HIV).

The FDA helps to ensure that all drugs, including those for the treatment of syphilis, are safe and effective for their intended use. FDA also provides guidance to drug developers to support efforts aimed at producing new therapies for syphilis prevention and treatment.

The U.S Department of Health and Human Services established a Federal Task Force in response to the rising number of cases of syphilis and congenital syphilis nationwide. The Task Force will utilize federal resources to reduce rates, promote health equity, engage impacted communities, and direct resources to support individuals most impacted by syphilis. Learn more about the Task Force’s actions to help stop the spread of syphilis.

Sexual Transmitted Infections (STI) Awareness Week

STI Awareness Week is a time set aside to raise awareness and educate individuals on preventing, testing for, and treating sexually transmitted infections. Sexually transmitted infections (STIs) are infections passed from one person to another through sexual contact. They are usually spread during vaginal, oral, or anal sex. Some STIs can be spread in utero or when giving birth. Types of STIs include chlamydia, gonorrhea, syphilis, human immunodeficiency virus (HIV), human papillomavirus (HPV) and more. Most STIs affect both men and women but may present differently in men and women. If an STI is spread in utero, it can cause serious health problems in the infant. If you are sexually active, talk with your health care provider about your risk for STIs and whether you need to be tested. 

Last year, the FDA authorized the first diagnostic test for chlamydia and gonorrhea with at-home sample collection. Typically, both chlamydia and gonorrhea can be treated, but if left untreated, both infections can cause serious health complications for patients, including infertility. The availability of STI testing can help patients get quicker results and access to treatment, ultimately helping to curb the rising rates of STIs.

Get the facts on HIV testing, prevention, and treatment and learn more about medicines to treat HIV with this booklet. Additionally, learn more about HPV and how to protect yourself with this resource from the FDA Office of Women’s Health

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