CNN
—
As shortages of front-line treatments continue, the U.S. Food and Drug Administration is working with a French pharmaceutical company to temporarily allow imports of syphilis drugs.
French pharmaceutical company Laboratoire Delbert said: letter In the United States, the company announced it is working with the FDA to temporarily import 3.5 million units of unapproved extensillin. The move was approved Wednesday, according to an update on the agency's website.
This is similar to Vicilin, a long-acting injection of the antibiotic penicillin made by Pfizer that has been in short supply since the middle of last year. It is the recommended treatment for syphilis in adults and is one of a wide range of options available for infections in children. However, this is the only treatment recommended for pregnant women and can prevent congenital syphilis, which is transmitted from mother to newborn.
In June, Pfizer said it was prioritizing manufacturing its adult-use formulation, but antibiotic manufacturing is so highly regulated and the products are so complex to manufacture that it won't be able to ramp up production as quickly as it would like. He said he couldn't do it.
In October, dozens of public health groups urged the White House to address the shortage as syphilis cases rose across the country. FDA drug shortage database It said the supply issue is expected to be resolved in the second quarter of this year.
From 2017 to 2021, the number of syphilis cases reported in the United States increased by approximately 74%, and the number of congenital syphilis cases increased by more than 203%, according to data from the Centers for Disease Control and Prevention. More than 3,700 infants infected with syphilis will be born in the United States in 2022, an increase of more than 1,000% from 2012 and the highest number in more than 30 years.
Syphilis in infants can be serious, disabling, and even life-threatening. Because congenital syphilis is almost always preventable, it is considered a “never event,” a tragic outcome that should never have happened. A single dose of penicillin given at least one month before birth almost guarantees that an infected mother will not pass the bacteria on to her baby.
Get CNN Health's weekly newsletter
The National Coalition of STD Directors, one of the groups that signed the letter to the White House in October, praised the FDA's move Wednesday.
“Delays in treatment due to shortages are putting women and their families at grave risk in the nation's syphilis crisis,” Executive Director David Harvey said in a statement. “Today, the administration responds to our continued call to do everything we can to address the Vicilin LA shortage and provide our communities with the resources they need to treat patients and solve this public health crisis, We have taken meaningful action. We hope this is a first step toward resolving this shortage and that HHS and FDA will continue to take steps to ensure that our communities never experience a syphilis treatment shortage again. Masu.”
CNN's Brenda Goodman and Meg Tyrrell contributed to this report.
