【Pharmaceutical Network Product InformationRecently, in a letter sent to the U.S. Food and Drug Administration (FDA), Pfizer stated that the company expects to run out of benzathine penicillin, a drug used to treat syphilis in children, by the end of June.
Data show that the main effect of benzathine penicillin is as a long-term preventive medication for patients with rheumatic fever and rheumatic heart disease. It can also be used to treat mild to moderate infections caused by susceptible bacteria, such as pneumonia, tonsillitis, and gonorrhea.
Syphilis is a chronic, systemic sexually transmitted disease caused by Treponema pallidum (TP) infection, mainly spread through sexual contact, mother-to-child transmission, and blood transmission. This disease is highly harmful and can affect almost all tissues and organs of the human body. Syphilis during pregnancy can also lead to preterm birth, miscarriage, and neonatal syphilis. Data released by the U.S. Centers for Disease Control and Prevention in April this year showed that the incidence of syphilis in the United States reached its highest level since 1990. In 2021, there were a total of 176,713 cases of syphilis, an increase of 32% over the previous year. Other sexually transmitted diseases are also becoming increasingly common.
With the increase in cases, the demand for benzathine penicillin has expanded. As early as April, Pfizer's benzathine penicillin (penicillin G) sold in the United States was added to the shortage list by the U.S. Food and Drug Administration (FDA).
Currently, Pfizer claims that the company is prioritizing the production of this drug. The first-choice treatment for syphilis during pregnancy is benzathine penicillin, which is also the only drug that can cross the placenta and treat the fetus.
In addition to benzathine penicillin, another antibiotic produced by Pfizer, procaine penicillin, which is used to treat other bacterial infections, is expected to be depleted by September 30.
Data show that procaine penicillin is the procaine salt of penicillin, with penicillin being the antibacterial active component. Penicillin exhibits good antibacterial activity against streptococci such as hemolytic streptococcus, Streptococcus pneumoniae, and staphylococci that do not produce penicillinase. This product also has antibacterial activity against Haemophilus influenzae and Bordetella pertussis. In addition, this product demonstrates effective antibacterial action against anaerobic bacteria such as Clostridium spp., Peptostreptococcus spp., and Prevotella melaninogenica. Penicillin exerts its bactericidal effect by inhibiting bacterial cell wall synthesis.
Pfizer mentioned in the letter that the supply disruption was the result of a combination of factors, including a significant increase in demand due to the rising rate of syphilis infections and the lack of competing products.
According to media reports, in fact, since October 2022, basic antibiotics in the United States have been in short supply. For instance, at that time, with the rising infection rates of respiratory diseases, the demand for antibiotics such as amoxicillin was exceeding supply.
Besides Pfizer, several other pharmaceutical companies that produce related products have also stated that they are facing difficulties of short-term supply shortages due to the impact of the pandemic, fluctuating demand, limitations in manufacturing capacity, and scarcity of raw materials.
Reportedly, regarding the supply shortages of Pfizer and other pharmaceutical companies, the FDA stated that it has detected drug shortages and is collaborating with companies and doctors to alleviate the situation. However, it does not have the authority to compel manufacturers to produce drugs or take other stringent measures. Additionally, in response to the shortage of anticancer drugs in the United States, the FDA is relaxing regulations on the importation of certain chemotherapy drugs as a way to address the shortage of cancer treatment drugs.
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