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.

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Agencies
May 26,2020

Tedros Adhanom Ghebreyesus, the World Health Organisation's (WHO) Director-General, said that a clinical trial of hydroxychloroquine (HCQ) on COVID-19 patients has come to "a temporary pause", while the safety data of the the anti-malaria drug was being reviewed.

According to the WHO chief, The Lancet medical journal on May 22 had published an observational study on HCQ and chloroquine and its effects on COVID-19 patients that have been hospitalized, reports Xinhua news agency.

The authors of the study reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate.

"The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on Saturday (May 23) and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally," Tedros said in a virtual press conference on Monday.

The review will consider data collected so far in the Solidarity Trial and in particular robust randomized available data, to adequately evaluate the potential benefits and harms from this drug, he said.

"The Executive Group has implemented a temporary pause of the HCQ arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board. The other arms of the trial are continuing," Tedros added.

WHO initiated the Solidarity Trial, a plan to evaluate the safety and efficacy of four drugs and drug combinations against COVID-19 more than two months ago, which include HCQ.

According to the WHO, over 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries under the Solidarity Trial.

Tedros added that the safety concern over the drug related only to the use of HCQ and chloroquine in COVID-19, and "these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria".

"WHO will provide further updates as we know more," he added.

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Agencies
June 10,2020

Early treatment with the antiviral drug remdesivir has been found to reduce viral load and prevent lung disease in macaques infected with SARS-CoV-2 that causes COVID-19, according to a study.

The findings, published in the journal Nature on Tuesday, support the early use of remdesivir treatment in patients with COVID-19 to prevent progression to pneumonia.

Researchers from the National Institutes of Health in the US noted that remdesivir has broad antiviral activity and has been shown to be effective against infections with SARS-CoV and MERS-CoV in animal models.

The drug is being tested in human clinical trials for the treatment of COVID-19, they said.

Researcher Emmie de Wit and colleagues investigated the effects of remdesivir treatment in rhesus macaques, a recently established model of SARS-CoV-2 infection.

Two sets of six macaques were inoculated with SARS-CoV-2.

One group was treated with remdesivir 12 hours later -- close to the peak of virus reproduction in the lungs -- and these macaques received treatment every 24 hours until six days after inoculation.

In contrast to the control group, the researchers found that macaques that received remdesivir did not show signs of respiratory disease, and had reduced damage to the lungs.

Viral loads in the lower respiratory tract were also reduced in the treated animals; viral levels were around 100 times lower in the lower-respiratory tract of remdesivir-treated macaques 12 hours after the first dose, they said.

The researchers said that infectious virus could no longer be detected in the treatment group three days after initial infection, but was still detectable in four out of six control animals.

Despite this virus reduction in the lower respiratory tract, no reduction in virus shedding was observed, which indicates that clinical improvement may not equate to a lack of infectiousness, they said.

Dosing of remdesivir in the rhesus macaques is equivalent to that used in humans, the researchers noted.

They cautioned that it is difficult to directly translate the timing of treatment used in corresponding disease stages in humans, because rhesus macaques normally develop only mild disease.

However, researchers said the results indicate that remdesivir treatment of COVID-19 should be initiated as early as possible to achieve the maximum treatment effect.

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Agencies
March 11,2020

With the sales of chicken and mutton going down due to the coronavirus scare, it is the humble 'Kathal' (jackfruit) is emerging as an acceptable alternative.

'Kathal' is now selling at ₹120 per kilogram -- an increase of more than 120 per cent over the normal ₹50 per kilogram.

The jackfruit, in fact, is now priced higher than chicken which is selling at ₹80 per kilogram due to poor demand.

"It is better having a 'Kathal' biryani instead of a mutton biryani. It tastes reasonably good. The only problem is that 'Kathal' has been sold out in the vegetable market and is difficult to find," said Purnima Srivastava whose family savours non-vegetarian food on a regular basis.

The corona scare has hit poultry business so hard and the Poultry Farm Association recently organized a Chicken Mela in Gorakhpur to dispel the misconception that birds are carriers of the deadly virus.

"In fact, we gave away plateful of chicken dishes for Rs 30 to encourage people to savour the delicacies. We cooked one thousand kilograms of chicken for the Mela and the entire stock was sold out," said Vineet Singh, head of the Poultry Farm Association.

However, the Mela did not do much to dispel the fears about chicken, mutton or fish consumption amid the virus outbreak.

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