FDA warns of serious side effects from drugs touted by Trump to treat coronavirus

The US Food and Drug Administration has warned against the use of two drugs that have been touted by President Donald Trump as potential treatments for the novel coronavirus.

FDA warns of serious side effects from drugs touted by Trump to treat coronavirus

The US Food and Drug Administration has warned against the use of two drugs that have been touted by President Donald Trump as potential treatments for the novel coronavirus.

The drugs, hydroxychloroquine and chloroquine, should only be used in hospitals or clinical trials because they can kill or cause serious side effects, the FDA said.

These include serious heart rhythm problems in COVID-19 patients treated with the drugs, especially when they are combined with the antibiotic azithromycin or other medications that can affect the heart.

"We are also aware of increased use of these medicines through outpatient prescriptions," the FDA said.

"Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine."

Trump has repeatedly touted the drugs, despite lack of evidence

He has mentioned the closely related drugs nearly 50 times since mid-March, according to a CNN analysis of his public comments.

The President has said the drugs would be a "game changer" in the fight against coronavirus, but a growing body of evidence suggests they may not help Covid-19 patients at all, and may do more harm than good.

"Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19," the FDA said on Friday.

A National Institutes of Health panel has also cautioned against their use.

The FDA said it was monitoring serious side effects in coronavirus patients who took the drugs.

In mid-March, the President said that hydroxychloroquine has "been around for a long time, so we know if things don't go as planned, it's not going to kill anybody."

But on Friday, the FDA said that "adverse events included abnormal heart rhythms such as QT interval prolongation, dangerously rapid heart rate called ventricular tachycardia and ventricular fibrillation, and in some cases, death."

In a statement, FDA commissioner Dr. Stephen Hahn said the agency understands that "health care professionals are looking for every possible treatment option for their patients," but he emphasized that the drugs come with risks.

"While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19," he said, "there are known side effects of these medications that should be considered."

The FDA said those risks "may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial," which is mentioned in an emergency-use authorization for the drugs issued last month.

Growing body of evidence suggests drugs may not help patients at all

Preliminary results from a large study of hydroxychloroquine suggest that the drug "didn't really have much of an effect on the recovery rate," New York Governor Andrew Cuomo said on Thursday.

The study, sponsored by the New York state Department of Health, looked at about 600 patients at 22 hospitals in the greater New York City area.

Those who took hydroxychloroquine, with or without the antibiotic azithromycin, were no more likely to survive their infections than those who did not, according to David Holtgrave, dean of the University at Albany School of Public Health, who conducted the study.

Like many studies on coronavirus, the research has not yet been peer-reviewed or formally published, but Holtgrave said "we don't see a statistically significant difference between patients who took the drugs and those who did not."

Another early study involving the Department of Veterans Affairs found that coronavirus patients taking hydroxychloroquine were no less likely to need mechanical ventilation than those who did not take the drug.

The research, which looked back at patients' charts to see how they fared, was not a controlled trial. But it found that patients who took hydroxychloroquine had higher deaths rates compared to those who didn't.

In a similar French study, researchers examined medical records from 181 coronavirus patients who had pneumonia and required supplemental oxygen.

About half had taken hydroxychloroquine within 48 hours of being admitted to the hospital, and the other half had not.

The study, which was published on a pre-print server before undergoing peer review, found no statistically significant difference in the death rates of the two groups, or in their chances of being admitted to the intensive care unit.

Eight patients who took the drug, though, developed abnormal heart rhythms and had to stop taking it.

Patients taking the drugs for approved reasons should continue doing so, FDA says

The FDA emphasized on Friday that patients taking the drugs for approved reasons should continue taking their medicine as prescribed.

Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria, the agency said, and hydroxychloroquine is also approved for certain autoimmune conditions such as lupus.

"The benefits of these medicines outweigh the risks at the recommended doses for these conditions," the agency said.

Source : 9 News More   

What's Your Reaction?


Next Article

Africa dangerously behind in global race for virus gear

Africa's coronavirus cases have surged 43% in the past week but its countries are dangerously behind in the global race for scarce medical equipment. Ten nations have no ventilators at all.

Africa dangerously behind in global race for virus gear

Africa's coronavirus cases have surged 43 per cent in the past week but its countries are dangerously behind in the global race for scarce medical equipment. Ten nations have no ventilators at all.

Outbid by richer countries, and not receiving medical gear from top aid donor the United States, African officials scramble for solutions as reported virus cases have climbed past 27,000. Even in the best scenario, the United Nations says 74 million test kits and 30,000 ventilators will be needed by the continent's 1.3 billion people this year. Very few are in hand.

"We are competing with the developed world," said John Nkengasong, director of the Africa Centers for Disease Control and Prevention. "The very future of the continent will depend on how this matter is handled."

Politicians instinctively try to protect their own people and "we know that sometimes the worst in human behavior comes out," said Simon Missiri, Africa director with the International Federation of Red Cross and Red Crescent Societies, urging an equitable approach to help developing nations.

The crisis has jolted African nations into creating a pooled purchasing platform under the African Union to improve negotiating power. Within days of its formation, the AU landed more than 100,000 test kits from a German source. The World Health Organisation is pitching in; it has reported fewer than 2,000 ventilators across 41 African countries.

On Friday the WHO hosted the launch of a global effort to ensure that vaccines, therapeutics and diagnostics reach all countries, rich or poor.

Africa also benefits from the U.N.'s largest emergency humanitarian operation in decades, with medical cargo including hundreds of ventilators arriving in Ethiopia this month and sent to all countries across the continent. Another shipment from the Jack Ma Foundation is on the way.

But Africa isn't holding out a begging bowl, Nkengasong said. Instead, it's asking for a fair crack at markets — and approaching China for "not donations. Quotas that Africa as a continent can purchase."

Such efforts are a response to a global thicket of protectionism: More than 70 countries have restricted exports of medical items, putting Africa in a "perilous position," the U.N. says. New travel bans have closed borders and airports, badly wrenching supply chains.

"It's like people hoarding toilet paper, which I still don't understand," Amer Daoudi, the U.N. World Food Program's senior director of operations, told The Associated Press. "Countries in Europe and North America are paying attention to their own internal needs, but we think that will ease off very soon."

While nations that are traditionally the world's top humanitarian donors are distracted, the WFP, the U.N.'s logistics leader, heaved the emergency operation into place with unprecedented reach. Normally in about 80 countries, this effort involves almost 120, Daoudi said.

The WFP seeks $350 million to keep the operation running for Africa and elsewhere, delivering aid for the pandemic and other crises like HIV and cholera that need drugs and vaccines to keep flowing. Africa imports as much as 94% of its pharmaceuticals, the U.N. says.

"I've never been involved in anything like this before. I don't think any of us have," said Stephen Cahill, WFP's director of logistics. "We're seeing countries taking measures we think aren't always rational. When you start closing borders, we start to get very nervous."

Some African nations, after securing equipment, have complicated delivery by causing cargo to stall at ports; 43 have closed their borders.

The global supply crisis is so pressing that the U.N. General Assembly this week approved a resolution urging countries to immediately end "speculation and undue stockpiling." Separately, China said it won't restrict exports of needed medical goods.

Developing regions take different approaches. China is the main source of help in Southeast Asia. In South Asia, several countries committed to India's proposed COVID-19 Emergency Fund. Small South Pacific island nations teamed up to get equipment. And some Latin American nations are trying to free equipment stuck in U.S. ports, or making supplies themselves.

But the global disruptions are especially felt across Africa, where governments that have historically underfunded health systems are partnering in an effort that's been compared to going to war.

"Where a product cost, for example, a dollar before, it's now gone up a hundred-fold," said Africa CDC deputy director Ahmed Ogwell. While many African nations have money on hand, the trading companies they use face extreme challenges: "Country X can go and say, 'I'll pay you double what you're offered.'"

In the United States, the Trump administration has said coronavirus aid to at-risk countries would not include key medical equipment, to meet demand at home.

"I've heard no situation yet in any of our countries where the U.S. has made any medical supplies available anywhere," said Charles Franzen, director of humanitarian and disaster response for World Relief.

When asked how many ventilators and test kits have been sent to Africa, a senior U.S. administration official said aid has focused on water, sanitation and messaging: "We're also looking at the PPE and ventilator needs and will be making those decisions very quickly," the official said.

So African public and private health sectors have teamed up as never before. "Irresponsible behaviour by richer countries" will not solve the pandemic, said Amit Thakker, president of the Africa Healthcare Federation, criticising "any country that diverts supplies for the sake of their own citizens" at developing countries' expense.

The private Business for South Africa works closely with the health ministry to get supplies. With better-resourced countries more likely to score deals, "that's not great for Africa. ... Ventilators are like trying to spot a dodo bird at the moment, literally," said Stavros Nicolaou, who leads BSA's efforts.

South Africa has worked with economic allies to obtain drugs from India and protective gear from China, Nicolaou said, but with the pandemic arriving in Africa later than elsewhere, "we have entered the fray quite late when the supply chain is highly, highly constrained."

As the pandemic hits countries at different times, one of Africa's most prominent philanthropists, Sudanese-born billionaire Mo Ibrahim, said, "this is the time for everybody to act together, not to compete."

Source : 9 News More   

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.