Laboratoires Delbert SAS

TUESDAY, Jan. 30, 2024 -- U.S. cases of syphilis have soared past numbers seen just a decade ago, new government statistics show. The grim numbers are for 2022, the latest year for which an accurate tally is available. More than 202,000 cases were recorded among Americans that year -- a 17% rise over 2021 numbers and an 80% rise over numbers recorded in 2018, the report from the U.S. Centers for Disease Control and Prevention found. Congenital syphilis -- when the disease is passed from a mother to her newborn -- can be very harmful to infants, and those cases have also risen at an alarming rate. Over 3,700 such cases were reported in 2022, the CDC reported in November , including 231 stillbirths and 51 infant deaths. Left untreated, syphilis in adults can damage the heart and brain and cause blindness, deafness and paralysis. Why the steady, sharp rise in cases? Experts believe that reductions in condom use have occurred as more Americans are turning to drug regimens that effectively prevent HIV infections without condoms. According to the New York Times , condom use by high school students has fallen by 8 percentage points between 2011 and 2021. The number of clinics focused on sexual health has also declined nationwide, experts say. “Sexual health services remain inadequate relative to the need pretty much everywhere,” Dr. Jay Varma , chief medical officer at Siga Technologies and a former deputy commissioner of health for New York City, told the Times . “But it’s particularly a problem here in the United States,” Varma said. “When you miss one case, you then end up with two more cases, and if you miss two cases, you then end up with four. That’s how epidemics grow.” Outbreaks can happen anywhere. According to the new report, South Dakota recorded the highest rate of syphilis infections in 2022 of any state, followed by New Mexico. Arkansas, Oklahoma and Mississippi took the third, fourth and fifth spots on that list. Race and ethnicity left some populations more vulnerable. A full 30% of cases occurred among Black Americans, while Native American/Alaska Natives had the highest rate of any ethnic group, at 67 cases per 100,000. The crisis has been compounded by a shortage of drugs crucial to treating syphilis. Bicillin , a long-acting injectable form of penicillin made by Pfizer, 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’s the only recommended treatment for pregnant women to prevent syphilis passing from mother to newborn. Earlier this month, the U.S. Food and Drug Administration said it would allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the Paris-based company said it’s working with the FDA to temporarily import 3.5 million units of Extencilline, which is not approved for use in the United States. The CDC has also recommended that people at higher risk for syphilis take the antibiotic doxycycline after unprotected sexual encounters. Studies have shown that taking the antibiotic doxycycline within 72 hours of sex might help prevent a sexually transmitted infection. Dr. Jonathan Mermin directs the National Center for HIV, Viral Hepatitis, STD and TB Prevention at the CDC. Speaking to the Times , he said the CDC is also pushing research into a simple test for syphilis that can be used at clinics and might be available within the next two years. He believes that curbing the ongoing epidemic of syphilis will require organized efforts by doctors, hospitals, community health centers and drug treatment programs. “Wishing hard won’t prevent sexually transmitted infections,” Mermin said. “We need sustained public health efforts.” Sources Sexually Transmitted Infections Surveillance, Jan. 30, 2024 New York Times 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. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Pfizer's Bicillin has been in short supply since last April. With U.S. syphilis cases on the rise and Pfizer’s Bicillin treatment still in short supply, France’s Laboratoires Delbert is stepping in to help with temporary imports. The French drugmaker is working with the FDA to bring in shipments of its Extencilline to the U.S. The product, while not approved in the U.S., is made up of penicillin G benzathine (or benzathine benzylpenicillin), which Pfizer has branded as Bicillin. In a letter (PDF) published by the FDA, Laboratoires Delbert noted that it will import 1,200,000 units of its powdered Extencilline and 2,400,000 units of the diluent version for reconstitution for injection. The meds are manufactured in Italy and both lots have an expiration date of 2025. Bicillin is used for an array of bacterial infections such as strep throat, but it's the preferred treatment for syphilis and gonorrhea. The FDA first reported a shortage of the treatment in April. In June, Pfizer updated its hospital customers on the supply interruption, attributing the supply shortfall to a “complex combination of factors” including a spike in demand. In its letter, Pfizer said it had prioritized its Bicillin manufacturing capacity and that its supplies would dwindle throughout the year. At the time, Pfizer estimated that four of its combination doses would be back in stock by mid-2024. The company is the only U.S. supplier of penicillin G benzathine injections. In response to the shortage, the Centers for Disease Control and Prevention (CDC)’s division of STD prevention recommended mitigation strategies be employed by healthcare providers, including discouraging Bicillin use for other infectious diseases. Last April, the CDC reported a nearly 32% jump in syphilis cases from 2020 to 2021 and a 203% rise over the last five years. The recent spike could be a continuation of disruptions in STD screenings over the COVID-19 pandemic, according to the agency. A more recent CDC report found that more than 3,700 babies were born with syphilis in 2022, representing a tenfold increase since 2012. Almost nine in ten cases of newborn syphilis could have been prevented with timely testing and treatment.

THURSDAY, Jan. 11, 2024 -- Amid an ongoing shortage of the 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. In a letter from Laboratoires Delbert, the Paris-based company said it’s 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’s the only recommended treatment for pregnant women to prevent syphilis passing from mother to newborn. The National Coalition of STD Directors applauded the FDA’s 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 . “Today, the administration took meaningful action on our ongoing ask they do anything and everything in their power to address the Bicillin L-A shortage and to provide communities with the resources they need to treat patients and solve this public health crisis." "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,” Harvey added. 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’s drug shortages database says the supply problem should ease in the second quarter of 2024. Syphilis cases have jumped about 74% between 2017 and 2021, while cases of syphilis in newborns increased more than 203%, according to data from the U.S. Centers for Disease Control and Prevention. Syphilis in infants can be severe, disabling and even fatal. A single course of penicillin at least a month before delivery nearly always prevents infected mothers from passing the disease to their babies. Sources FDA Drug Shortages database, Jan. 10, 2024 CNN 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. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.