Widely used diabetes drug can cause flesh-eating genital infection

Agencies
August 31, 2018

The U.S. Food and Drug Administration is warning doctors and patients that some widely used diabetes drugs may, in some rare cases, cause a flesh-eating bacterial infection of the genitals. The condition, known as Fournier’s gangrene, developed in a dozen patients shortly after they began taking the medicines between March 2013 and May 2018, the FDA said. The seven men and five women were all hospitalized and underwent surgery for the condition. One patient died.

More cases may be uncovered once the risk is better understood, the agency said in a statement. The drugs covered by the warning include Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga and Eli Lilly & Co.’s Jardiance. Known as SGLT2 inhibitors, they were approved in 2013, 2013 and 2016, respectively. The drugs help the body lower blood-sugar levels via the kidneys, and excess sugar is excreted in a patient’s urine. Urinary tract infections are a known side effect.

In comparison, the FDA found only six cases of the condition, all in men, in a review of all other diabetes drug classes for the past three decades. The drugs are expected to generate as much as $7.1 billion in sales by 2020, according to Bloomberg Intelligence. The FDA estimates about 1.7 million patients got a prescription for one of the medicines from a retail pharmacy in 2017, underscoring how rare the condition is.

All of the drugs in the class except Merck & Co.’s Steglujan, the most recently approved, have been linked to the condition. The manufacturers must add information about the risk to the prescribing information and medicine guides given to patients. AstraZeneca said it is working with the agency on updating the label and noted that it hadn’t seen any cases of the condition during the development of Farxiga. Officials at the other companies didn’t immediately return phone calls and emails requesting comment.

Diabetics using the drugs should seek immediate medical attention if they develop tenderness, redness or swelling of the genitals, and if they have even a slight fever of 100.4 degrees Fahrenheit, the agency said. The symptoms can worsen quickly, so it’s important to get help immediately, the drug agency said.

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
Agencies
February 23,2020

Los Angeles, Feb 23: According to researchers, if administered quickly, a common medication that reduces bleeding could be a treatment for bleeding stroke.

The Spot Sign and Tranexamic Acid on Preventing ICH Growth - Australasia Trial (STOP-AUST) was a multicenter, prospective, randomized, double-blind, placebo-controlled, phase 2 clinical trial using the antifibrinolytic agent tranexamic acid in people with intracerebral hemorrhage (ICH).

ICH is a severe form of acute stroke with few treatment options.

Tranexamic acid is currently used to treat or prevent excessive blood loss from trauma, surgery, tooth removal, nosebleeds and heavy menstruation. For this study, one hundred patients with active brain bleeding were given either intravenous tranexamic acid or placebo within 4.5 hours of symptom onset.

Researchers analyzed brain CT scans taken during the 24-hour period after treatment with tranexamic acid or placebo.

Researchers found a trend towards reduced hemorrhage expansion in the group treated with tranexamic acid, especially in those treated within 3 hours of the brain bleed. However, this trend was not statistically significant. The finding was consistent with previous research using the medication.

"Further trials using tranexamic acid are ongoing and focusing on ultra-early treatment - within 2 hours. 

This is where the greatest opportunity for intervention appears to be. Tranexamic acid is inexpensive, safe and widely available. Our results and others provide great impetus for further, focused research using this treatment," Nawaf Yassi said.

Larger trials focused on patient outcomes are required for this therapy to enter routine clinical practice.

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
Agencies
April 15,2020

Dear parents, if you want your children to have proper sleep, read this carefully. Joining a growing list of studies that tell parents to shun devices at bed-time, researchers say that children who use devices and decide what time they go to sleep, achieve less sleep and feel more sleepier the following day than their peers.

The study of children in this age-group (aged 11 to 13 years), published in the New Zealand Medical Journal, found most (72 per cent) of the 163 students interviewed by University of Otago researchers achieved recommended guidelines of an average 9 to 11 hours sleep nightly over one week.

"But that also means that almost one in four students did not achieve sleep within these guidelines, which highlights an area for improvement," said study researcher Kate Ford.

However, consistent with previous research in 15 to 17-year-old New Zealanders, the study results show less sleep on the nights where devices are used in the hour before bed.

According to the researchers, students who used devices before going to sleep were also more likely to report that they felt sleepy the following morning. Watching television before bed had no significant effect on sleep length.

There were also some interesting observations over the weekends where students went to bed later but woke later achieving similar sleep length to the school days, the researchers said.

A small group of students (six per cent) who reported less than seven hours of sleep, including a small number reporting not sleeping at all, according to the study,

Therefore, while the average across the week of 72 per cent of students reporting adequate sleep is reassuring, it is far from the goal of every child achieving sleep within the recommended guidelines," Ford said.

Dr Paul Kelly, head of the Sleep Health Service at Canterbury District Health Board, supervised the study and explained that the foundations for good health are based on proper nutrition, regular exercise and good sleep quality.

Sleep quality is often overlooked as a contributory factor to poor health.

"The study findings suggest the need for parental guidance around bedtimings and moderation of the use and availability of electronic devices before bed," Kelly said.

"Respect and protect your sleep, as good daytime functioning is reliant on adequate sleep," Kelly added.

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
Agencies
January 26,2020

High-protein diets may help people lose weight and build muscle, but there is a downside to it --a greater heart attack risk. Researchers now report that high-protein diets boost artery-clogging plaque.

The research in mice showed that high-protein diets spur unstable plaque -- the kind most prone to rupturing and causing blocked arteries.

More plaque buildup in the arteries, particularly if it's unstable, increases the risk of heart attack.

"There are clear weight-loss benefits to high-protein diets, which has boosted their popularity in recent years," said senior author Babak Razani, associate professor at Washington University School of Medicine in St. Louis, Missouri.

"But animal studies and some large epidemiological studies in people have linked high dietary protein to cardiovascular problems. We decided to take a look at whether there is truly a causal link between high dietary protein and poorer cardiovascular health," Razani added.

The researchers studied mice who were fed a high-fat diet to deliberately induce atherosclerosis, or plaque buildup in the arteries.

Some of the mice received a high-fat diet that was also high in protein. And others were fed a high-fat, low-protein diet for comparison.

The mice on the high-fat, high-protein diet developed worse atherosclerosis -- about 30 per cent more plaque in the arteries -- than mice on the high-fat, normal-protein diet, despite the fact that the mice eating more protein did not gain weight, unlike the mice on the high-fat, normal-protein diet.

"A couple of a scoop of protein powder in a milkshake or smoothie adds something like 40 grams of protein -- almost equivalent to the daily recommended intake," Razani said.

"To see if protein has an effect on cardiovascular health, we tripled the amount of protein that the mice receive in the high-fat, high-protein diet -- keeping the fat constant. Protein went from 15 per cent to 46 per cent of calories for these mice".

Plaque contains a mix of fat, cholesterol, calcium deposits and dead cells. Past work by Razani's team and other groups has shown that immune cells called macrophages work to clean up plaque in the arteries.

But the environment inside plaque can overwhelm these cells, and when such cells die, they make the problem worse, contributing to plaque buildup and increasing plaque complexity.

"In mice on the high-protein diet, their plaques were a macrophage graveyard," Razani informed.

To understand how high dietary protein might increase plaque complexity, Razani and his colleagues also studied the path protein takes after it has been digested -- broken down into its original building blocks, called amino acids.

"This study is not the first to show a telltale increase in plaque with high-protein diets, but it offers a deeper understanding of the impact of high protein with the detailed analysis of the plaques," said Razani.

"This work not only defines the critical processes underlying the cardiovascular risks of dietary protein but also lays the groundwork for targeting these pathways in treating heart disease," he added.

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.