\n\t\t\t\t\t\tDrugmaker Pfizer is warning doctors that it expects to run low on supplies of Bicillin L-A, a long-acting injection of the antibiotic penicillin, the preferred option for treating syphilis during pregnancy.The news \u2013 the latest twist in a drug shortage that began in 2023 \u2013 follows a July 10 recall of certain lots of Bicillin L-A that were found to be contaminated with floating particles. Pfizer says it has not received any reports of adverse events related to the recalled shots.\u201cWe have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,\u201d the company said in a statement, adding that it places the utmost emphasis on patient safety. \u201cWe fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.\u201dBenzathine penicillin G, sold as Bicillin, is used to treat a number of common bacterial infections, such as strep throat, in adults and children. Because one shot can last up to two weeks, it\u2019s especially helpful for people who can\u2019t swallow pills or may not be able to remember to take them. In most cases, however, if the shots aren\u2019t available, doctors can turn to alternatives like the antibiotic doxycycline.But benzathine penicillin G is the only product that\u2019s approved and recommended to treat the sexually transmitted infection syphilis during pregnancy. If the infection is caught early, a single injection can keep the infection from spreading to a newborn, a condition called congenital syphilis.Without treatment, syphilis during pregnancy can cause miscarriages and stillbirths. It can also be fatal for infants. Syphilis can also cause vision and hearing problems in babies as well as deformities of the bones and teeth.As rates of syphilis rose in adults, more babies became infected, too. Over the past decade, rates of congenital syphilis have increased tenfold in the United States, from 335 in 2012 to more than 3,800 in 2023, according to data from the U.S. Centers for Disease Control and Prevention.\u201cWe\u2019re in the midst of a congenital syphilis crisis, and we\u2019ve been calling for an emergency declaration for congenital syphilis for years,\u201d said Dr. Jeffrey Klausner, a professor of clinical population and public health sciences at the University of Southern California\u2019s Keck School of Medicine. \u201cThis threatens to make that even worse.\u201dThe shot has been a key part of the strategy that some states have been using to quell rising rates of congenital syphilis.Because too many pregnant patients infected with syphilis weren\u2019t making it into basic primary care, there\u2019s been a push in states including New Mexico and Minnesota to test all pregnant women for syphilis at multiple stages of pregnancy and whenever they show up in emergency rooms or urgent care clinics.After an initial positive test, providers are encouraged to treat a pregnant patient with a shot of long-acting penicillin at the same visit, without waiting for the results of a second confirmatory test.This push for one-stop testing and treatment has already had an effect.\u201cWith the latest release of data, we saw a slowing of rates, which was really exciting,\u201d said a CDC official familiar with the data who asked not to be named because they weren\u2019t authorized to speak to the media. That progress is the result of hard work bringing awareness to controlling syphilis and congenital syphilis, the official said.Bicillin L-A most recently went into shortage in 2023. During that time, the U.S. Food and Drug Administration has allowed imports of two equivalent products, a French drug called Extencilline, and Lentocilin, which is imported from Portugal and sold by entrepreneur Mark Cuban\u2019s Cost Plus Drugs. These imports continue to be authorized.Those forms of the medication are trickier to use, said Erin Fox, associate chief pharmacy officer at the University of Utah Health.\u201cIn a health system, it\u2019s very hard to use imported products,\u201d she said. The bar coding on the drugs isn\u2019t recognized by most hospital systems, and there may be differences in how the products are mixed and diluted, which can be confusing.Her hospital has been handling the shortage by being judicious about who gets Bicillin shots. It hasn\u2019t had to use an imported product yet.Pfizer has also been working to boost its supply. The company stopped shipping pediatric doses in 2023 and instead focused on making adult doses to prioritize supply for pregnant patients. According to the FDA\u2019s drug shortage website, Pfizer expected to have a delivery of pediatric doses available in October.Now, the company has advised customers that it will give an update on the Bicillin supply no later than mid-August. Until stock has fully recovered, Pfizer said, it will ration available supplies of the shots. Providers will have to fill out medical request forms, and the company will send supplies on a per-patient basis.Sterile injectable products like Bicillin are especially vulnerable to shortages because they have a more complex manufacturing process than pills and tend to be prone to quality control issues. In this case, Pfizer is the sole supplier of Bicillin for the U.S.The nonprofit National Coalition of STD Directors said it\u2019s gathering information from members to understand how far-reaching the impact of the recall may be.One of its committees met Monday, and all of the participants were in the process of returning Bicillin doses to Pfizer. One state returned about 800 vials, \u201cso we expect to hear this is widespread,\u201d said Elizabeth Finley, senior director of communications and programs for the organization.\u201cWe had a small reprieve for about, maybe a year, in terms of steady supply. And now this is just a complete kick in the teeth and really threatens our ability to prevent and control syphilis,\u201d Klausner said.The CDC had previously posted recommendations for caring for syphilis patients during the shortage, but that information has since been taken down. Fox, who investigates drug shortages for the Association of Health Systems Pharmacists, said she has asked the agency to repost it but hasn\u2019t received a response.CDC staffers who work on syphilis control were hit hard by recent government layoffs, although about 200 were reinstated in June. Federal funding cuts have also hampered state and local efforts to control sexually transmitted infections.The FDA updated its drug shortage page with links to Pfizer\u2019s recent guidance but has not posted Pfizer\u2019s recall announcement.A spokesperson for the U.S. Department of Health and Human services referred questions about the recall and potential supply problems to Pfizer.\u201cI am concerned though that now, with a cut in funds to national and local STD programs, that we will start to see a drop in testing for syphilis,\u201d the CDC official said. \u201cCuts to Medicaid and Medicare, as well as other programs, will be devastating for syphilis control.\u201d\n\t\t\t\t\t<\/p>\n
Drugmaker Pfizer is warning doctors that it expects to run low on supplies of Bicillin L-A, a long-acting injection of the antibiotic penicillin, the preferred option for treating syphilis during pregnancy.<\/strong><\/p>\n The news \u2013 the latest twist in a drug shortage that began in 2023 \u2013 follows a July 10 recall<\/a> of certain lots of Bicillin L-A that were found to be contaminated with floating particles. Pfizer says it has not received any reports of adverse events related to the recalled shots.<\/p>\n \u201cWe have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,\u201d the company said in a statement, adding that it places the utmost emphasis on patient safety. \u201cWe fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.\u201d<\/p>\n Benzathine penicillin G, sold as Bicillin, is used to treat a number of common bacterial infections, such as strep throat, in adults and children. Because one shot can last up to two weeks, it\u2019s especially helpful for people who can\u2019t swallow pills or may not be able to remember to take them. In most cases, however, if the shots aren\u2019t available, doctors can turn to alternatives like the antibiotic doxycycline.<\/p>\n But benzathine penicillin G is the only product that\u2019s approved and recommended to treat the sexually transmitted infection syphilis during pregnancy. If the infection is caught early, a single injection can keep the infection from spreading to a newborn, a condition called congenital syphilis.<\/p>\n Without treatment, syphilis during pregnancy can cause miscarriages and stillbirths. It can also be fatal for infants. Syphilis can also cause vision and hearing problems in babies as well as deformities of the bones and teeth.<\/p>\n As rates of syphilis rose in adults, more babies became infected, too. Over the past decade, rates of congenital syphilis have increased tenfold in the United States, from 335 in 2012 to more than 3,800 in 2023<\/a>, according to data<\/a> from the U.S. Centers for Disease Control and Prevention.<\/p>\n \u201cWe\u2019re in the midst of a congenital syphilis crisis, and we\u2019ve been calling for an emergency declaration for congenital syphilis for years,\u201d said Dr. Jeffrey Klausner, a professor of clinical population and public health sciences at the University of Southern California\u2019s Keck School of Medicine. \u201cThis threatens to make that even worse.\u201d<\/p>\n The shot has been a key part of the strategy that some states have been using to quell rising rates of congenital syphilis.<\/p>\n Because too many pregnant patients infected with syphilis weren\u2019t making it into basic primary care, there\u2019s been a push in states including New Mexico<\/a> and Minnesota<\/a> to test all pregnant women for syphilis at multiple stages of pregnancy and whenever they show up in emergency rooms or urgent care clinics.<\/p>\n After an initial positive test, providers are encouraged to treat a pregnant patient with a shot of long-acting penicillin at the same visit, without waiting for the results of a second confirmatory test.<\/p>\n This push for one-stop testing and treatment has already had an effect.<\/p>\n \u201cWith the latest release of data, we saw a slowing of rates, which was really exciting,\u201d said a CDC official familiar with the data who asked not to be named because they weren\u2019t authorized to speak to the media. That progress is the result of hard work bringing awareness to controlling syphilis and congenital syphilis, the official said.<\/p>\n Bicillin L-A most recently went into shortage in 2023. During that time, the U.S. Food and Drug Administration has allowed imports of two equivalent products, a French drug called Extencilline, and Lentocilin, which is imported from Portugal and sold by entrepreneur Mark Cuban\u2019s Cost Plus Drugs. These imports continue to be authorized.<\/p>\n Those forms of the medication are trickier to use, said Erin Fox, associate chief pharmacy officer at the University of Utah Health.<\/p>\n \u201cIn a health system, it\u2019s very hard to use imported products,\u201d she said. The bar coding on the drugs isn\u2019t recognized by most hospital systems, and there may be differences in how the products are mixed and diluted, which can be confusing.<\/p>\n Her hospital has been handling the shortage by being judicious about who gets Bicillin shots. It hasn\u2019t had to use an imported product yet.<\/p>\n Pfizer has also been working to boost its supply. The company stopped shipping pediatric doses in 2023 and instead focused on making adult doses to prioritize supply for pregnant patients. According to the FDA\u2019s drug shortage website<\/a>, Pfizer expected to have a delivery of pediatric doses available in October.<\/p>\n Now, the company has advised customers<\/a> that it will give an update on the Bicillin supply no later than mid-August. Until stock has fully recovered, Pfizer said, it will ration available supplies of the shots. Providers will have to fill out medical request forms, and the company will send supplies on a per-patient basis.<\/p>\n Sterile injectable products like Bicillin are especially vulnerable to shortages because they have a more complex manufacturing process than pills and tend to be prone to quality control issues. In this case, Pfizer is the sole supplier of Bicillin for the U.S.<\/p>\n The nonprofit National Coalition of STD Directors said it\u2019s gathering information from members to understand how far-reaching the impact of the recall may be.<\/p>\n One of its committees met Monday, and all of the participants were in the process of returning Bicillin doses to Pfizer. One state returned about 800 vials, \u201cso we expect to hear this is widespread,\u201d said Elizabeth Finley, senior director of communications and programs for the organization.<\/p>\n \u201cWe had a small reprieve for about, maybe a year, in terms of steady supply. And now this is just a complete kick in the teeth and really threatens our ability to prevent and control syphilis,\u201d Klausner said.<\/p>\n The CDC had previously posted recommendations<\/a> for caring for syphilis patients during the shortage, but that information has since been taken down. Fox, who investigates drug shortages for the Association of Health Systems Pharmacists, said she has asked the agency to repost it but hasn\u2019t received a response.<\/p>\n CDC staffers who work on syphilis control were hit hard by recent government layoffs, although about 200 were reinstated in June. Federal funding cuts have also hampered state and local efforts to control sexually transmitted infections.<\/p>\n The FDA updated its drug shortage page<\/a> with links to Pfizer\u2019s recent guidance but has not posted Pfizer\u2019s recall announcement.<\/a><\/p>\n A spokesperson for the U.S. Department of Health and Human services referred questions about the recall and potential supply problems to Pfizer.<\/p>\n \u201cI am concerned though that now, with a cut in funds to national and local STD programs, that we will start to see a drop in testing for syphilis,\u201d the CDC official said. \u201cCuts to Medicaid and Medicare, as well as other programs, will be devastating for syphilis control.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Drugmaker Pfizer is warning doctors that it expects to run low on supplies of Bicillin L-A, a long-acting…\n","protected":false},"author":3,"featured_media":68105,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[26859,23050,48251,48259,48246,48247,16460,638,48252,48253,26835,48256,48261,48248,151,210,48260,6454,48249,26878,48254,1060,48258,48255,30898,11164,881,26012,554,290,48250,34204,48257,45609,67,132,68],"class_list":{"0":"post-68104","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-rate","9":"tag-antibiotic","10":"tag-benzathine-penicillin-g","11":"tag-bicillin","12":"tag-bicillin-l-a","13":"tag-bicillin-recall","14":"tag-cdc","15":"tag-company","16":"tag-congenital-syphilis","17":"tag-drug-contamination","18":"tag-drug-shortage","19":"tag-drugmaker-pfizer","20":"tag-equivalent-product","21":"tag-extencilline","22":"tag-fda","23":"tag-health","24":"tag-infection-syphili","25":"tag-infectious-diseases","26":"tag-lentocilin","27":"tag-mark-cuban","28":"tag-maternal-health","29":"tag-medication","30":"tag-new-recall","31":"tag-penicillin","32":"tag-pfizer","33":"tag-pregnancy","34":"tag-public-health","35":"tag-shnd","36":"tag-shot","37":"tag-state","38":"tag-std-programs","39":"tag-supply","40":"tag-syphili","41":"tag-syphilis","42":"tag-united-states","43":"tag-unitedstates","44":"tag-us"},"share_on_mastodon":{"url":"","error":"Validation failed: Text character limit of 500 exceeded"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/68104","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=68104"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/68104\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/68105"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=68104"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=68104"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=68104"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}