US FDA Temporarily Allows Import of French Syphilis Drug to Address Shortages
In response to the alarming shortage of syphilis treatment drugs in the United States, the U.S. Food and Drug Administration (FDA) has granted temporary permission for the import of a syphilis drug manufactured by France’s Laboratoires Delbert, according to an announcement made by the company on Wednesday.
Laboratoires Delbert is actively collaborating with the FDA to facilitate the importation of extencilline, a vital medication used in the treatment of syphilis. The announcement came in the form of a letter posted on the FDA’s official website, outlining the efforts to alleviate the critical shortages of syphilis drugs in the United States.
This move comes after pharmaceutical giant Pfizer had issued a warning in June, indicating an imminent depletion of its supply of Bicillin L-A, a drug crucial for treating syphilis and various bacterial infections in children. The scarcity was attributed to the company’s decision to prioritize manufacturing versions tailored for adults due to a notable increase in syphilis infections within that demographic.
Pfizer’s penicillin products, including Bicillin L-A, have been grappling with shortages since April, as highlighted on the FDA’s official website. A survey conducted in August revealed that almost one-third of U.S. hospital pharmacists were compelled to ration, delay, or even cancel treatments due to the escalating drug shortages, reaching an all-time high in the country.
It’s worth noting that Delbert’s extencilline, being a form of penicillin, is not currently approved for use in the United States. However, the FDA’s temporary approval reflects the urgency of addressing the shortages and ensuring that patients receive necessary treatment amidst the challenging circumstances.
Syphilis, a preventable and curable bacterial sexually transmitted infection (STI), has become a growing concern. The World Health Organization reported that in 2020, an estimated 7.1 million adults between the ages of 15 and 49 were affected by this infection globally. The current import authorization by the FDA is a significant step towards managing the public health crisis and ensuring that individuals in need of syphilis treatment have access to the necessary medications.
