Clotrimazole

THURSDAY, Jan. 11, 2024 -- U.S. doctors are prescribing antifungal creams to patients with skin complaints at rates so high they could be contributing to the rise of drug-resistant infections, new research shows. These are "severe antimicrobial-resistant superficial fungal infections , which have recently been detected in the United States," noted a team led by Jeremy Gold, a researcher at the U.S. Centers for Disease Control and Prevention. One of the biggest emerging threats: Drug-resistant forms of ringworm (a form of dermatophytosis). In Southeast Asia, major outbreaks of this itchy, circular rash have occurred that are not responding to either topical antifungal creams or pills. Cases of ringworm resistant to drugs have also now been spotted in 11 U.S. states, Gold's team noted. This is leading to "patients experiencing extensive lesions and delays in diagnosis," the team said. As is seen with the overuse of antibiotics, fungi naturally build up resistance to antifungal meds the more they are exposed to them. The CDC team believes that antifungal topical creams are being overprescribed. Looking at 2021 Medicare Part D data, they found that 6.5 million prescriptions for creams containing antifungals, such as ketoconazole, nystatin and clotrimazole-betamethasone, were prescribed that year. In sheer numbers, primary care doctors wrote the biggest percentage of these prescriptions, but dermatologists and podiatrists had much higher rates on a prescriptions-per-doctor basis. One of the big issues, according to Gold's team, is that most doctors diagnose a skin condition simply by looking at it, a method that is "frequently incorrect," even among board-certified dermatologists. "Confirmatory diagnostic testing" of a skin lesion beyond just looking at it is rarely done, they added. A small percentage of physicians are prescribing antifungal drugs at exceedingly high rates. In 2021, "10% of antifungal prescribers prescribed nearly one half of these medications," Gold's group found. The new study probably only captures a fraction of the overuse of antifungals, since "most topical antifungals can be purchased over the counter without a prescription," the researchers noted. The high use of clotrimazole-betamethasone, in particular, is thought to be a big factor in the emergence of drug-resistant ringworm. This drug (a combination of a steroid and an antifungal) can also "cause skin damage if applied to intertriginous areas," meaning areas where the skin folds onto itself, such as occurs around the groin, buttocks and armpits. Long-term, extensive use of clotrimazole-betamethasone can also trigger hormonal problems, Gold's team said. The bottom line, according to the CDC team: "Health care providers should be judicious in prescribing topical antifungals" for suspected fungal skin infections, and go beyond a visual diagnosis when possible. Doctors should also try to "educate patients about the correct use of topical antifungals and combination antifungal-cortoicosteroids" to help reduce overprescribing and the danger of drug-resistant fungal disease, they added. The findings were published in the Jan. 11 issue of the CDC journal Morbidity and Mortality Weekly Report . Sources Morbidity and Mortality Weekly Report, Jan. 11, 2024 Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

On Monday, Teva Pharmaceuticals and Glenmark Pharmaceuticals became the sixth and seventh drugmakers to resolve criminal charges as a result of the Department of Justice’s yearslong investigation into generic drug price fixing. The settlement agreement requires both companies to pay hefty fines as well as divest their drug lines for pravastatin, a widely used statin that lowers cholesterol. In 2019, the DOJ showed that it was serious about cracking down on generic drug price fixing by issuing two multi-million dollar fines to Heritage Pharmaceuticals and Rising Pharmaceuticals. The legal case at the center of Monday’s settlement dates back to 2020, when the DOJ indicted Teva over alleged price fixing conspiracies with four other generic drugmakers — Glenmark, Sandoz, Apotex and Taro Pharmaceuticals. The indictment charged the pharma companies with raising prices, rigging bids and allocating customers for generic drugs. These medications included pravastatin, as well as generic drugs for autoimmune diseases, pain, cancer and cystic fibrosis. In 2020, Taro, Sandoz and Apotex admitted their roles in the alleged schemes and paid fines respectively totaling $205.7 million, $195 million and $24.1 million. With Monday’s settlement, Teva and Glenmark have also admitted to their roles in running a price fixing scheme and agreed to pay criminal penalties. The DOJ ordered Teva to pay a $225 million penalty, which the department said is the largest fine to date for “a domestic antitrust cartel.” As for Glenmark, the DOJ issued the firm a $30 million fine. The settlement agreement also requires both Teva and Glenmark to divest their respective drug lines for pravastatin, which was at the center of the companies’ alleged price fixing scheme. In addition to the $225 million penalty, the DOJ ordered Teva to donate $50 million worth of drugs to humanitarian organizations. Those drugs are antifungal medication clotrimazole and antibiotic drug tobramycin The prices of both were affected by the conspiracy, the DOJ said. If either company violates the terms of their settlement agreement, they will face prosecution. If convicted, they would likely get banned from federal healthcare programs like Medicare and Medicaid, according to the DOJ’s statement. “When a firm is criminally convicted, it is barred from participating in U.S. federal healthcare programs. Teva Pharmaceuticals is one of the largest generic pharmaceutical firms in the world, so barring it from much of the healthcare industry would be dangerous. The right response is to shrink the firm and force it to disgorge illicit profits, which is what the antitrust division did,” Matt Stoller, director of research at the antitrust advocacy group American Economic Liberties Project, said in a statement. In a press release issued Monday, Teva said it “fosters a culture of compliance” and “has robust and consistent compliance controls in place” to prevent price fixing schemes from recurring in the future. Glenmark did not respond to MedCity News’ request for comment. In 2019, Heritage agreed to pay more than $7 million to settle its price fixing case, and Rising was issued a penalty totaling more than $3 million. Collectively, seven drugmakers have agreed to pay nearly $700 million as a result of the DOJ’s crackdown on generic drug price fixing.