FDA Approves New Treatment for Urinary Tract Infections, What to Know

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The Food and Drug Administration has approved Pivya for the treatment of uncomplicated urinary tract infections in female adults. Mascot/Getty Images
  • The Food and Drug Administration (FDA) recently approved a new antibiotic to treat Urinary tract infection (UTI),
  • Doctors can now prescribe a medicine called Pivya (pivmecillinum) to female adults suffering from uncomplicated UTIs.
  • Clinical trials show that Pivya is effective and side effects are limited.
  • As antibiotic resistance continues to increase, the addition of Pivya to the available treatments is a welcome addition.

Urinary tract infections (UTIs) are one of the most common reasons for visiting general practitioners. During his lifetime, approximately 1 in 2 women will be an experience UTIaccounting for surroundings 25% In all infections occurring in women.

Treatment for UTIs can vary and often requires Antibiotic medicines, Now, for the first time 20 years In the United States, the FDA has allowed A new oral antibiotic for the treatment of complicated UTIs. The drug, pivmecillinum, marketed as Pivya, is a synthetic version. penicillin,

Experts describe a UTI as “uncomplicated” when the urinary tract is otherwise healthy, and there are no chronic conditions, immune problems, recent urological surgery, or pregnancy.

Treating UTIs with Pivaya may be new in the US, but doctors in Canada and some European countries have been prescribing the drug for UTIs for the past 40 years. In fact, the first studies demonstrating the effectiveness of Pivya against simple UTIs were published in 1970s,

Pivya is a narrow-spectrum antibiotic, meaning it only kills a small number of bacterial species. For this reason, Pivya is approved for use only in UTIs caused by Escherichia coli, Proteus mirabilisAnd staphylococcus saprophyticus,

the drug is owned utility medical scienceA company that focuses on the treatment of UTIs.

The FDA’s April 24 approval of Pivya was based on the results of three clinical trials:

Pivya vs placebo

This study included 271 participants. Of those who received Pivya, 62% achieved an overall response, compared with 10% in the placebo group.

Pivya vs other antibacterials

Scientists recruited 259 people for this study. Overall, 72% of those taking Pivya achieved an overall response, compared with 76% of those taking other antimicrobial drugs.

Pivya vs Ibuprofen

In this studyInvolving 224 people, 66% of people who took Pivya had an overall response, compared with 22% of people who took ibuprofen.

The most important measurement in these studies was the “overall response rate”, which combines two important outcomes:

  • Clinical Treatment: The symptoms of uncomplicated UTI have gone away and no new symptoms have appeared.
  • Microbiological response: The level of bacteria in urine decreases.

The overall response rate means that symptoms have subsided and the bacteria have been eliminated.

Overall, these studies show that Pivya worked better than placebo and ibuprofen and other similar antibiotics. Side effects were also relatively minor. Typically, they included nausea and diarrhea.

Healthline asked Niels Frimodt-MöllerProfessor at the Department of Clinical Microbiology at Rigshospitalet in Denmark and an expert in UTIs, about the possible side effects of the new FDA-approved drug.

“All drugs have adverse effects, but this one has relatively few side effects. However, it produces allergic reactions just like other penicillins,” he said.

The FDA states that certain people should avoid using Pivya, including “carnitine Deficiency resulting from hereditary disorders of mitochondrial fatty acid oxidation and carnitine metabolism. as well as people living together genetic abnormality Medicine should be avoided.

Healthline spoke to Björn Asheim Hansen, MD, of Vestfold Hospital Trust in Denmark, who has published papers on pivmecillinum,

“Of course, like every other medicine it also has side effects like nausea and rash. But Pivya tolerates it well,” Hansen said.

As noted by the FDA, Hansen said “there are some concerns”. carnitine deficiency, which can cause serious symptoms. However, Hansen believes it has “insignificant clinical consequences” and is currently writing a paper on the subject.

Prevalence of UTI is increasingespecially in high-income countries like the US

UTIs are an unpleasant and painful experience for young people. in older adults who are more sensitive For them, a UTI can become even more serious, leading to hospitalization. In some cases, UTIs in older adults can be fatal.

While antibiotic treatment for UTIs is generally effective, increasing numbers of bacteria have developed ways to protect themselves from antibiotics, making them less effective. It is known as antibiotic resistanceAnd this is a serious and growing public health concern.

A global monitoring report of World Health Organization, (WHO) It was found that about 20% e coli Urine samples — the most common cause of UTIs — were found to be resistant to first- and second-line antibiotics. According to reports, this accounts for about 1 in 5 cases of UTI.

Thomas Lodis, PharmD, PhDA professor at the Albany College of Pharmacy and Health Sciences and a clinical pharmacist at the Stratton VA Medical Center in Albany, New York, told Healthline that “resistance to two of the most widely used oral antibiotics for uncomplicated UTIs is 20 It has been reported to be more than. %” in most areas of the US

That’s why discovering new drugs or, as in this case, revisiting neglected antibiotics, is an important area of ​​research.

Having a new antibiotic to treat UTIs is a positive step, but it does not completely address the issue of antibiotic resistance, which is a growing problem around the world.

Moller explained that, while Pivya is “a great antibiotic for uncomplicated UTIs, if it is used too widely, it will generate resistance like all other antibiotics.”

However, Hansen said he has “used the drug for decades in Scandinavia and yet resistance is not a problem.” Pivya-related antibiotic resistance still at low levels – around 5%,

According to some expertsThis may be because Pivya does not interfere with the bacteria living in the gut.

Henson cited mounting evidence That Pivaya may also be effective against antibiotic-resistant e coliWhich may have future implications for how this drug is prescribed.

The FDA has approved the first new antibiotic to treat simple UTIs in two decades. The move will help health professionals tackle the growing problem of antibiotic resistance and provide relief to the many people experiencing this condition.