Nystatin

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.

Generic drug firms Taro Pharmaceuticals USA, Novartis’ Sandoz, and Apotex have agreed with the US Department of Justice to pay $447.2 million on top of the more than $400 million in criminal penalties they already paid to resolve alleged violations that they illegally collaborated on price, supply and allocation of customers with other pharma manufacturers. Each of the companies entered a five-year corporate integrity agreement, which includes internal monitoring and price transparency provisions, among other checks and balances. New York-based Taro will pay almost half of that latest sum, or $213.2 million, for alleged violations involving the nonsteroidal drug etodolac, and nystatin-triamcinolone cream and ointment to treat skin infections. Sandoz agreed to pay $185 million related to alleged issues with benazepril HCTZ, used to treat hypertension, and clobetasol, a corticosteroid used to treat skin conditions. “The conduct at issue here occurred at Sandoz from March 2013 through December 2015 in direct contravention of the company’s values, policies and trainings in place at the time. The individuals implicated in the underlying conduct are no longer employed by the company,” Sandoz said in a statement. And Florida-based Apotex agreed to pay $49 million in connection with its sale of pravastatin, a drug used to treat high cholesterol and triglyceride levels. Apotex is also part of another ongoing investigation involving pravastatin price-fixing allegations, involving Teva Pharmaceuticals and Glenmark Pharmaceuticals. This latest $447 million payout also follows the payment of separate criminal penalties, in which Taro paid $205.6 million and admitted to conspiring with two other generic drug companies to fix prices on certain generic drugs, while Sandoz paid another $195 million and admitted to conspiring with four other generic drug companies to fix prices on certain generic drugs, and Apotex paid $24.1 million and admitted to conspiring to increase and maintain the price on pravastatin.