ear infections

Short on amoxicillin, physicians reach for alternatives to treat ear infections

Posted by

0


Key takeaways:

  • The amoxicillin shortage has led to the use of alternative therapies to treat ear infections.
  • Cefdinir and amoxicillin clavulanate were more likely to be prescribed for acute otitis media during shortage.

A national shortage of amoxicillin led to an increase in the use of alternative agents to treat ear infections, according to a study published in Pediatrics.

Last fall, the FDA announced that the United States was experiencing a shortage of amoxicillin, which is commonly used to treat acute otitis media and other infections of the ear.

IDC0823Brewster_Graphic_01

“As a resident physician, we have exposure to a lot of different clinical settings,” Ryan C.L. Brewster, MD, a resident in pediatrics at Boston Children’s Hospital and Boston Medical Center, told Healio.

“We observed very early on that the shortage was leading to a lot of changes in management decisions,” Brewster said. “We wanted to try and understand these practice patterns more systematically, while thinking about the clinical and policy implications.”

Following the FDA’s announcement and the AAP recommending alternative treatments for acute otitis media, Brewster and colleagues hypothesized that prescriptions for amoxicillin would immediately decrease and there would be more use of broader spectrum antibiotics “and a gradual return to baseline prescribing patterns.”

They conducted a retrospective study of 3,076 encounters involving children aged younger than 18 years who were diagnosed with acute otitis media or an ear infection from May 2022 through April 2023. They used Oct. 28, 2022 — the date the FDA declared the shortage — to separate what they called the “pre-shortage” and “post-shortage” periods, the latter of which encompassed 54% of the encounters they counted.

“We were particularly interested in how sudden changes in medication availability can impact health systems, so we analyzed trends in not only in amoxicillin prescribing, but also other traditionally second line agents like amoxicillin clavulanate, or Augmentin, and cefdinir as well as watchful waiting,” Brewster said.

They found that 54% of total encounters included an amoxicillin prescription, whereas 21.8% of patients were prescribed amoxicillin-clavulanate and 8.6% were prescribed cefdinir. The odds of being prescribed amoxicillin decreased by 91% after the FDA shortage declaration, whereas the odds of being prescribed amoxicillin-clavulanate increased sevenfold and the odds of a cefdinir prescription increased ninefold.

“What was compelling about our results is that amoxicillin prescribing fell dramatically and abruptly after the FDA declaration,” Brewster said. “Simultaneously, there was a shift toward these other second-line agents like Augmentin and cefdinir. To our knowledge, this is the first time such a domino effect has been characterized in literature.”

Brewster said that the study also highlighted a broader underinvestment in many pediatric drugs and products, including formula and acetaminophen.

“Many antibiotics, like amoxicillin, are generic medications and have low profitability, and drug manufacturers therefore don’t have strong reasons to create resilient supply chains,” Brewster said. “Unanticipated levels of demand in the setting of the ‘tripledemic’ exposed the weaknesses of this system. It is important to advocate for policies that that prevent and mitigate the effects of drug shortages, such as strategic stockpiling and incentives for production. Manufacturers should also be held more accountable in reporting shortages and resolution timelines.”

Brewster said other “interesting areas” to explore are the effects on antimicrobial resistance, cost and medication errors.

“The question that follows is, To what extent does this impact outcomes?” Brewster said. “Acute otitis media tends to be a fairly benign infection that responds well to first- and second-line medications. If the same shifts in management are happening with other, more serious conditions — for example, chemotherapy for cancer patients — drug shortages could carry significant consequences.”

FDA Approves Xtoro

Posted by

0


The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.
 Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal. Activities in which the ear is underwater can create a moist environment where bacteria may sometimes grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear and discharge from the ear.Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections.

“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Xtoro’s safety and efficacy were primarily established in two clinical trials where 1,234 participants between the ages of 6 months and 85 years were randomly assigned to receive Xtoro or its vehicle (a solution without a fluoroquinolone). Clinical cure was achieved if the ear tenderness, redness and swelling were completely resolved.

Among 560 participants whose acute otitis externa was confirmed to be caused by Pseudomonas aeruginosa or Staphylococcus aureus, 70 percent who received Xtoro achieved clinical cure versus 37 percent who received the vehicle. In addition, Xtoro was superior to the vehicle for clearing the bacteria based on ear culture, and eased ear pain sooner than the vehicle.

The most common side effects reported in Xtoro-treated participants were itching of the ear (pruritis) and nausea.

Xtoro is manufactured Alcon Laboratories, Inc., based in Fort Worth, Texas.

Source: FDA

//

// g?c=a+f+c:(g+=f.length,f=a.indexOf("&",g),c=0<=f?a.substring(0,g)+c+a.substring(f):a.substring(0,g)+c)}return 2E3<c.length?void 0!==d?r(a,b,d,void 0,e):a:c};var ba=function(){var a=/[&\?]exk=([^& ]+)/.exec(v.location.href);return a&&2==a.length?a[1]:null};var ca=function(a){var b=a.toString();a.name&&-1==b.indexOf(a.name)&&(b+=": "+a.name);a.message&&-1==b.indexOf(a.message)&&(b+=": "+a.message);if(a.stack){a=a.stack;var c=b;try{-1==a.indexOf(c)&&(a=c+"\n"+a);for(var d;a!=d;)d=a,a=a.replace(/((https?:\/..*\/)[^\/:]*:\d+(?:.|\n)*)\2/,"$1");b=a.replace(/\n */g,"\n")}catch(e){b=c}}return b},w=function(a,b){a.google_image_requests||(a.google_image_requests=[]);var c=a.document.createElement("img");c.src=b;a.google_image_requests.push(c)};var x=document,v=window;var da=String.prototype.trim?function(a){return a.trim()}:function(a){return a.replace(/^[\s\xa0]+|[\s\xa0]+$/g,"")},ea=function(a,b){return ab?1:0};var y=null,fa=function(a,b){for(var c in a)Object.prototype.hasOwnProperty.call(a,c)&&b.call(null,a[c],c,a)};function z(a){return"function"==typeof encodeURIComponent?encodeURIComponent(a):escape(a)}var ga=function(){if(!x.body)return!1;if(!y){var a=x.createElement("iframe");a.style.display="none";a.id="anonIframe";y=a;x.body.appendChild(a)}return!0},ha={};var ia=!0,ja={},ma=function(a,b,c,d){var e=ka,f,g=ia;try{f=b()}catch(k){try{var C=ca(k);b="";k.fileName&&(b=k.fileName);var t=-1;k.lineNumber&&(t=k.lineNumber);g=e(a,C,b,t,c)}catch(l){try{var u=ca(l);a="";l.fileName&&(a=l.fileName);c=-1;l.lineNumber&&(c=l.lineNumber);ka("pAR",u,a,c,void 0,void 0)}catch(wa){la({context:"mRE",msg:wa.toString()+"\n"+(wa.stack||"")},void 0)}}if(!g)throw k;}finally{if(d)try{d()}catch(hb){}}return f},ka=function(a,b,c,d,e,f){var g={};if(e)try{e(g)}catch(k){}g.context=a;g.msg=b.substring(0,512);c&&(g.file=c);0<d&&(g.line=d.toString());g.url=x.URL.substring(0,512);g.ref=x.referrer.substring(0,512);na(g);la(g,f);return ia},la=function(a,b){try{if(Math.random()c?Math.max(0,a.length+c):c;if(n(a))return n(b)&&1==b.length?a.indexOf(b,c):-1;for(;c<a.length;c++)if(c in a&&a[c]===b)return c;return-1},ra=B.map?function(a,b,c){return B.map.call(a,b,c)}:function(a,b,c){for(var d=a.length,e=Array(d),f=n(a)?a.split(""):a,g=0;g<d;g++)g in f&&(e[g]=b.call(c,f[g],g,a));return e};var sa={c:947190538,d:947190541};if(x&&x.URL)var ta=x.URL,ia=!(ta&&(0<ta.indexOf("?google_debug")||0b&&v.setTimeout(pa("osd_listener::ldcl_int",c),100)};c()};var va=function(){try{v.localStorage.setItem("__sak","1");var a=v.localStorage.__sak;v.localStorage.removeItem("__sak");return"1"==a}catch(b){return!1}},xa=function(a,b,c){a.google_image_requests||(a.google_image_requests=[]);var d=a.document.createElement("img");D(d,"load",c,"osd::ls_img::load");d.src=b;a.google_image_requests.push(d)};var ya=function(a,b){for(var c in a)b.call(void 0,a[c],c,a)},E=function(a){var b=arguments.length;if(1==b&&"array"==m(arguments[0]))return E.apply(null,arguments[0]);for(var c={},d=0;dparseFloat(a))?String(b):a}(),Ga={},Ha=function(a){if(!Ga[a]){for(var b=0,c=da(String(Fa)).split("."),d=da(String(a)).split("."),e=Math.max(c.length,d.length),f=0;0==b&&f<e;f++){var g=c[f]||"",k=d[f]||"",C=RegExp("(\\d*)(\\D*)","g"),t=RegExp("(\\d*)(\\D*)","g");do{var l=C.exec(g)||["","",""],u=t.exec(k)||["","",""];if(0==l[0].length&&0==u[0].length)break;b=ea(0==l[1].length?0:parseInt(l[1],10),0==u[1].length?0:parseInt(u[1],10))||ea(0==l[2].length,0==u[2].length)||ea(l[2],u[2])}while(0==b)}Ga[a]=0b;){if(c.google_osd_static_frame)return c;if(c.aswift_0&&(!a||c.aswift_0.google_osd_static_frame))return c.aswift_0;b++;c=c!=c.parent?c.parent:null}}catch(d){}return null},Pa=function(a,b,c,d){if(10<Na)v.clearInterval(J);else if(++Na,v.postMessage&&(b.b||b.a)){var e=Oa(!0);if(e){var f={};Ka(b,f);f[0]="goog_request_monitoring";f[6]=a;f[16]=c;d&&d.length&&(f[17]=d.join(","));try{var g=Ma(f);e.postMessage(g,"*")}catch(k){}}}};E("area base br col command embed hr img input keygen link meta param source track wbr".split(" "));E("action","cite","data","formaction","href","manifest","poster","src");E("embed","iframe","link","script","style","template");var Qa;if(!(Qa=!Ca&&!G)){var Ra;if(Ra=G)Ra=G&&9<=Ja;Qa=Ra}Qa||Ca&&Ha("1.9.1");G&&Ha("9");var Sa,K=0,L="",M=!1,N=!1,O=!1,Ta=!1,Ua=[],I=null,P="",Va=[],Wa=[],Xa=!1,Q="",R="",Ya=(new Date).getTime(),Za=["1","0","3"],S=0,T=!1,U="",V=null,W=0,X=0,$a=0,ab=function(a,b){M&&Y(a,b,!0);(O||N&&Ta)&&Y(a,b)},Y=function(a,b,c){if((b=b||P)&&!Xa&&(2==X||c)){b=bb(b,c);if(!c&&T){T=!1;V&&(a.clearInterval(V),V=null);var d=U;try{a.localStorage[d]=b+"&timestamp="+p()+"&send"}catch(e){}5!=S&&xa(a,b,function(){a.localStorage.removeItem(d)})}else w(a,b);c?M=!1:Xa=!0}},bb=function(a,b){var c;c=b?"osdim":O?"osd2":"osdtos";var d=["//pagead2.googlesyndication.com/activeview","?id=",c];"osd2"==c&&N&&Ta&&d.push("&ts=1");L&&d.push("&avi=",L);Sa&&d.push("&cid=",Sa);0!=S&&d.push("&lsid=",S);T&&d.push("&cwls=1");d.push("&ti=1");d.push("&",a);d.push("&uc="+$a);c=d.join("");for(d=0;d<Va.length;d++){try{var e=Va[d]()}catch(f){}var g="max_length";2<=e.length&&(3==e.length&&(g=e[2]),c=r(c,z(e[0]),z(e[1]),g))}2E3<c.length&&(c=c.substring(0,2E3));return c},Z=function(a,b){if(Q){try{var c=r(Q,"vi",a);ga()&&w(y.contentWindow,c)}catch(d){}0<=qa(Za,a)&&(Q="");var c=b||P,e;e=r("//pagead2.googlesyndication.com/pagead/gen_204?id=sldb","avi",L);e=r(e,"vi",a);c&&(e+="&"+c);try{w(v,e)}catch(f){}}},cb=function(){Z("-1")},eb=function(a){if(a&&a.data&&n(a.data)){var b;var c=a.data;if(n(c)){b={};for(var c=c.split("\n"),d=0;d=e)){var f=Number(c[d].substr(0,e)),e=c[d].substr(e+1);switch(f){case 5:case 8:case 11:case 15:case 16:e="true"==e;break;case 4:case 7:case 6:case 14:e=Number(e);break;case 3:if("function"==m(decodeURIComponent))try{e=decodeURIComponent(e)}catch(g){throw Error("Error: URI malformed: "+e);}break;case 17:e=ra(decodeURIComponent(e).split(","),Number)}b[f]=e}}b=b[0]?b:null}else b=null;if(b&&(c=new H(b[4],b[12]),I&&I.match(c))){for(c=0;cW&&2==X){var a=v,b="//pagead2.googlesyndication.com/pagead/gen_204?id=osd2&",c=[];c.push("ovr_value="+K);c.push("avi="+L);I&&(c=c.concat(La()));c.push("tt="+((new Date).getTime()-Ya));a.document&&a.document.referrer&&c.push("ref="+z(a.document.referrer));c.push("hs="+W);b+=c.join("&");try{w(a,b)}catch(d){}}},db=function(a){var b=a.match(/^(.*&timestamp=)\d+$/);return b?b[1]+p():a+"&timestamp="+p()},gb=function(){var a={};Ka(I,a);a[0]="goog_dom_content_loaded";var b=Ma(a);ua(function(){var a=Oa(!1),d=!a;!a&&v&&(a=v.parent);if(a&&a.postMessage)try{a.postMessage(b,"*"),d&&v.postMessage(b,"*")}catch(e){}})};q("osdlfm",A("osd_listener::init",function(a,b,c,d,e,f,g,k,C,t){K=a;Q=b;R=d;M=f;S=C||0;Sa=t;N=g&&f;1!=k&&2!=k||Ua.push(sa["MRC_TEST_"+k]);I=new H(e,ba());D(v,"load",cb,"osd_listener::load");D(v,"message",eb,"osd_listener::message");L=c||"";D(v,"unload",fb,"osd_listener::unload");var l=v.document;!l.readyState||"complete"!=l.readyState&&"loaded"!=l.readyState?("msie"in ha?ha.msie:ha.msie=-1!=navigator.userAgent.toLowerCase().indexOf("msie"))&&!window.opera?D(l,"readystatechange",function(){"complete"!=l.readyState&&"loaded"!=l.readyState||gb()},"osd_listener::rsc"):D(l,"DOMContentLoaded",gb,"osd_listener::dcl"):gb();-1==K?X=f?3:1:-2==K?X=3:0v.localStorage.length&&(U="LSPNGS-"+I.toString()+"-"+(""+Math.random()).split(".")[1]+p(),T=!0,V=v.setInterval(pa("osd_listener::ls_int",function(){var a=v,b=U,c=a.localStorage[b];if(c)try{a.localStorage[b]=db(c)}catch(d){}}),1E3));I&&(I.b||I.a)&&(W=1,J=v.setInterval(pa("osd_proto::reqm_int",aa(Pa,X,I,N,Ua)),500))}));q("osdlac",A("osd_listener::lac_ex",function(a){Va.push(a)}));q("osdlamrc",A("osd_listener::lamrc_ex",function(a){Wa.push(a)}));q("osdsir",A("osd_listener::sir_ex",ab));})();osdlfm(-1,”,’BBtqJypaTVLK_OtOruASgpICICgDl2qjolgEAABABOAHIAQLgAgDIA50E4AQBoAYCqBOAAQ’,”,270852258,true,false,0,0,”);
// ]]>