1. Articles in category: Drug Safety

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    1. US Biotech Firm Donating 1.5M Doses of Experimental Coronavirus Drug

      US Biotech Firm Donating 1.5M Doses of Experimental Coronavirus Drug

      Gilead Sciences Inc., a U.S. biotechnology firm that develops and commercializes drugs, has rapidly expanded its supply of an experimental coronavirus drug and is prepared to donate 1.5 million doses of it to hospitals dealing with severely ill patients. 

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      Mentions: Coronavirus
    2. FDA Approves Trials to Test the Effectiveness of Anti-Malarial Drugs Against COVID-19

      FDA Approves Trials to Test the Effectiveness of Anti-Malarial Drugs Against COVID-19

      As touted by President Donald Trump, on Sunday, an emergency authorization was issued by the Food and Drug Administration (FDA) in Washington. It was regarding the use of chloroquine and hydroxychloroquine – both anti-malaria drugs, for experimental coronavirus treatments, despite the inconclusive clinical proof of their efficacy.

      However, on Sunday, the Department of Health and Human Services had announced that distribution of hydroxychloroquine and chloroquine products can be done by doctors, and they may prescribe these drugs to hospitalized teen and adult patients that are infected with COVID-19, as appropriate, in the situation where the availability or feasibility of a clinical trial are not seen.

      According to HHS, 30 million doses of hydroxychloroquine has already been given by Germany’s Sandoz ...

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      Mentions: Coronavirus
    3. Essential Drug Supplies for Virus Patients Are Running Low

      Essential Drug Supplies for Virus Patients Are Running Low

      Medicines to alleviate breathing difficulty, relieve pain and sedate coronavirus patients are in very high demand, depleting stock around the country.

      Across the country, as hospitals confront a harrowing surge in coronavirus cases, they are also beginning to report shortages of critical medications — especially those desperately needed to ease the disease’s assault on patients’ respiratory systems.

      The most commonly reported shortages include drugs that are used to keep patients’ airways open, antibiotics, antivirals and sedatives. They are all part of a standard cocktail of medications that help patients on mechanical ventilators, control secondary lung infections, reduce fevers, manage pain and resuscitate those who go into cardiac arrest.

      Demand for these drugs significantly increased in March as the pandemic took ...

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      Mentions: Coronavirus
    4. Health Groups Urge Feds to Slow Opioid Production Limits Amid Coronavirus

      Health Groups Urge Feds to Slow Opioid Production Limits Amid Coronavirus

      Multiple health groups have banded together to urge the federal government to relax opioid production limits during the coronavirus crisis in a letter sent Tuesday.

      The groups, including the American Hospital Association, sent a letter to the Drug Enforcement Administration (DEA), requesting the federal agency to increase the annual quotas for manufacturers and outsourcing facilities to develop opioids for the duration of the national emergency. 

      The quotas had been tightened due to the opioid addiction crisis. The organizations said hospitals are struggling to obtain enough controlled substances that “are necessary to mechanically ventilate patients safely and effectively.” They said the DEA needs to approve the increase in production “if they have any hope of meeting the current enormous demand surge ...

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      Mentions: Coronavirus
    5. Supreme Court to Decide if Big Pharma Can be Sued as Drug Dealers

      Supreme Court to Decide if Big Pharma Can be Sued as Drug Dealers

      Drug makers are pushing the Tennessee Supreme Court to block a move by state prosecutors to hold Big Pharma financially accountable for the opioid epidemic, Knox News has learned.

      Tennessee’s high court has now agreed to consider whether the state’s district attorneys general can sue opioid makers Endo Pharmaceuticals, Purdue Pharma, Mallinckrodt Pharmaceuticals and Teva Pharmaceuticals using a law targeting drug dealers, according to an order made public Tuesday.

      The high court is also allowing a coalition of corporate and insurance attorneys representing big business — the International Association of Defense Counsel — to weigh in, the order shows.

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    6. Drug Used To Fight Ebola Being Tested To Cure COVID-19

      Drug Used To Fight Ebola Being Tested To Cure COVID-19

      More than 3,500 COVID-19 related deaths have now been reported in the United States. That number tops those reported in all of China, but there is a hopeful sign right here in Chicago. COVID-19 patients are undergoing an experimental treatment at Northwestern with a drug that was used to treat Ebola patients.

      Now two hospitals, Northwestern Memorial Hospital and University of Illinois at Chicago Medical Center, are part of an international trial to see if it could help treat COVID-19 as well. It is a double-blind trial, meaning that neither the doctor nor the patients knows if they’re on the drug, but they are hopeful they could see some results soon.

      “This is one looking at an agent ...

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    7. Mississippi Hospitals File Lawsuit Against Opioid Manufacturers, Distributors, Retailers

      Mississippi Hospitals File Lawsuit Against Opioid Manufacturers, Distributors, Retailers

      A group of 11 Mississippi hospitals have filed a civil suit in the Circuit Court of Hinds County against manufacturers, distributors and retailers of opioid-based drugs. Mississippi hospitals have been on the front lines fighting and treating the complications of addiction as the opioid crisis has reached epidemic levels.

      Mississippi was one of the top five opioid prescribing states in the nation in 2017. For every 100 persons, 92.9 opioid prescriptions were written, compared to the U.S. average of 58.7 prescriptions. In 2018, enough opioids were dispensed for every man, woman and child in Mississippi to have 50 doses each.

      "The opioid epidemic placed an incredible strain on the already overburdened health care system in Mississippi and ...

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      Mentions: Coronavirus
    8. White House Pressures FDA on Unproven Japanese Drug

      White House Pressures FDA on Unproven Japanese Drug

      The Trump administration is encouraging regulators to allow a decades-old flu drug to be administered as a possible coronavirus treatment, despite career officials’ concerns about the risks and limited evidence that the drug would work as a coronavirus treatment, according to three officials with knowledge of the deliberations and internal documents reviewed by POLITICO.

      Japanese Prime Minister Shinzo Abe has championed the drug, Avigan, as a possible treatment, and clinical trials are now getting underway in Japan. Chinese scientists also have touted the drug, produced by Japan-based Fujifilm, as a potential coronavirus treatment, but global regulators and U.S. researchers have long expressed concern about the drug’s risks, such as birth defects, and have warned that the Chinese data ...

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      Mentions: Coronavirus
    9. Lupus Patients Face Medication Shortage as Drug is Used For Coronavirus

      Lupus Patients Face Medication Shortage as Drug is Used For Coronavirus

      The FDA has given emergency approval for doctors to use anti-malaria drugs to treat the coronavirus. Now, millions of doses could be sent to hospitals across the country. One of those malaria medications, hydroxychloroquine, is already used for chronic conditions like lupus. In Springfield, Grove Pharmacy is completely out of it already, and that is starting to worry people who already rely on it. 

      "It's not just the people that might get COVID-19 who are at risk. There are other people whose lives are in danger, said Esther Guy. "My life is in danger if I'm not able to get my medications."

      "Lupus used to be a death diagnosis," she said. She was diagnosed in 2012 and there ...

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      Mentions: Coronavirus
    10. $7.5M in Payouts To Former Jail Detainees Denied Prescription Drugs

      $7.5M in Payouts To Former Jail Detainees Denied Prescription Drugs

      Cook County is set to pay $7.5 million to settle a class-action lawsuit that accused it of failing to administer prescription drugs in a timely manner to incoming Cook County Jail detainees, according to a preliminary agreement reached in federal court.

      The lawsuit said sheriff’s officials and the county had waited longer than 24 hours to provide new detainees with medication for ailments including asthma and mental health problems. The settlement covers detainees who entered the jail between 2005 and 2013.

      “This closes the book on a terrible chapter in the jail,” said Kenneth Flaxman, the lead attorney for the detainees. “By 2013, the problems were pretty much gone.” The sheriff’s office and county didn’t admit ...

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    11. Meth Replaces Opioids As Key Drug Problem in Many Areas

      Meth Replaces Opioids As Key Drug Problem in Many Areas

      Because of threats from methamphetamine users, home deliveries from the food bank in Louisa, Ky., require a police escort. A shop owner carries her gun to work, and the constable, who rarely had to pull his weapon in the past, has drawn it a dozen times in a  year, the New York Times reports. Meth’s sudden return in a powerful new form has bred fear and division in the community of 2,500 as a growing number of users have begun living on the streets. A public push to end opioid abuse has unwittingly ushered in the return of crystal meth. In Concord, N.H., which was ravaged by opioids, the police say methamphetamine now accounts for 60 percent ...

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    12. FDA Issues Emergency Authorization of Anti-Malaria Drug for Coronavirus Care

      FDA Issues Emergency Authorization of Anti-Malaria Drug for Coronavirus Care

      The Food and Drug Administration on Sunday issued an emergency use authorization for hydroxychloroquine and chloroquine, decades-old malaria drugs championed by President Donald Trump for coronavirus treatment despite scant evidence.

      The agency allowed for the drugs to be "donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," HHS said in a statement, announcing that Sandoz donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.

      The move was supported by the White House, part of a larger Trump-backed effort to speed the use of anti-malaria drugs as a potential therapy ...

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    13. FDA Warns Against Fraudulent Coronavirus Tests, Vaccines and Treatments

      FDA Warns Against Fraudulent Coronavirus Tests, Vaccines and Treatments

      Consumers should beware of buying or using products that sellers claim will help diagnose, treat, cure or prevent COVID-19 as the coronavirus continues to sweep across the country, the U.S. Food and Drug Administration said Wednesday. 

      Some companies are trying to profit from the pandemic by selling unproven and illegally marketed products and falsely claiming they are able to prevent or cure the coronavirus, the FDA said.

      “Because COVID-19 has never been seen in humans before, there are currently no vaccines to prevent or drugs to treat” the coronavirus that have been approved by the FDA, the agency said. “These fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety ...

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      Mentions: Coronavirus
    14. Mayo Clinic Warns Drug Claimed to be COVID-19 cure Will "Claim Lives"

      Mayo Clinic Warns Drug Claimed to be COVID-19 cure Will "Claim Lives"

      Concerned that the sudden interest in their use for coronavirus could cause fatal heart arrhythmias in a small percentage of what could become millions of users, Mayo Clinic on Wednesday, March 25, issued urgent guidanceadvising cardiac screening of all who take hydroxychloroquine and chloroquine, malaria drugs touted by President Donald Trump and others as effective for the treatment and prevention of COVID-19.

      "We thought it was critical to make people aware how to navigate through and around the sudden cardiac drug risk that does exist with these medications," said Mayo Clinic professor of cardiovascular medicine Dr. Michael Ackerman, "and that's why Mayo Clinic urgently assembled this special article."

      Hydroxychloroquine and the similar drug chloroquine are 80-year old malarial ...

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      Mentions: Coronavirus
    15. What Consumers Need to Know About Drug Shortages During the Coronavirus Pandemic

      What Consumers Need to Know About Drug Shortages During the Coronavirus Pandemic

      As America waits for grocery stores and sites like Amazon to restock toilet paper and thermometers, many wonder, what will happen with other essentials? Experts say there won’t be major disruptions in food supply, but analysts have expressed fears over disruptions in the drug supply chain. So what does that mean for consumers?

      Most large pharmacies and drug wholesalers keep at least a month or two of prescription meds as backup, and pharmaceutical companies store medications in case of supply disruptions.But during this pandemic, the drug supply “is not unlike the toilet paper situation,” where stores may be temporarily out of stock due to people panic buying, not because of major supply chain issues, Michael Ganio, director of ...

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      Mentions: Coronavirus
    16. A Malaria Drug Flops In Coronavirus Treatment

      A Malaria Drug Flops In Coronavirus Treatment

      A decades-old malaria drug touted by President Donald Trump as a potential coronavirus treatment has failed to impress in an early-stage study.

      The study, performed in China, followed 30 patients with mild symptoms. It investigated hydroxychloroquine, a cousin of chloroquine. Both can treat malaria, lupus and rheumatoid arthritis. In recent days, Trump has reiterated his positive views on their potential in coronavirus treatment.

      But the drug didn't pan out in the study, Evercore ISI analyst Umer Raffat said in a note to clients. He described the results as "far from positive." Of three key measures, just one favored the use of the malaria drugs in coronavirus treatment.

      "It really puzzles me why we're seeing inaccurate characterizations of clinical ...

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      Mentions: Coronavirus
    17. Scientists Chase Two Options in How to Treat Coronavirus

      Scientists Chase Two Options in How to Treat Coronavirus

      Doctors and scientists are working furiously to find effective treatments for the illness caused by the new coronavirus but are cautioning the public not to self-medicate or hoard mentioned drugs not yet proven to work.

      Despite widespread rumors, social media reports and President Donald Trump's own optimism surrounding the effectiveness of several existing drugs, so far there are no proven treatments for COVID-19, according to the U.S. Centers for Disease Control and Prevention.

      “There’s no magic drug out there right now,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a news conference Thursday. 

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      Mentions: Coronavirus
    18. Pharmacists Urge Caution About Potential Drugs to Treat COVID-19

      Pharmacists Urge Caution About Potential Drugs to Treat COVID-19

      There has been a lot of talk lately about certain drugs helping to fight COVID-19. President Donald Trump has even gone as far as talking about them, but there’s a problem. Doctors say we don’t actually know if they work or not.

      Patrick Brian and his pharmacy staff have become counselors in some ways, calming the fears of customers.

      “We’re doing everything we have to do to take care of our customers and make sure everybody stays well," said Brian, pharmacy manager. “Just making comments about the craziness of it. You get used to it, just to, it’s kind of scary and also to be able to try to have a little bit of levity with ...

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      Mentions: Coronavirus
    19. Delaware to Receive $1M From Drug Companies to Combat Opioid Addiction

      Delaware to Receive $1M From Drug Companies to Combat Opioid Addiction

      A new opioid impact fee created by the Delaware General Assembly last year created roughly $500,000 in additional funding for addiction treatments in just the first few months it's existed, with another half-million expected soon. 

      “I’m absolutely thrilled the nation’s first, successful opioid impact fee is working as designed,” said Sen. Stephanie Hansen, D-Middletown, prime sponsor of Senate Bill 34. “The pharmaceutical companies that created the addiction crisis are finally being held accountable and soon we will be using the money we collect to fund new tools and resources capable of breaking the cycle of abuse, addiction and death that has gripped this state for too long.”

      Delaware was listed as one of the Top 20 ...

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      Mentions: Breaking
    20. Drug Shortage is Result After Trump Touts Possible Cure

      Drug Shortage is Result After Trump Touts Possible Cure

      Excitement about treating the new coronavirus with malaria drugs is raising hopes, including with President Donald Trump. But the evidence that they may help is thin, and a run on the drugs is complicating access for people who need them for rheumatoid arthritis or lupus.

      Chloroquine and a similar drug, hydroxychloroquine, showed encouraging signs in small, early tests against the coronavirus. But the drugs have major side effects, one reason scientists don’t want to give them without evidence of their value, even in this emergency.

      Yet those preliminary studies sparked intense interest after Trump tweeted that hydroxychloroquine plus an antibiotic could be “one of the biggest game changers in the history of medicine” and should “be put in use ...

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      Mentions: Coronavirus
    21. Toxicologist Says Malaria Drugs Show 'Promise' in Treating Coronavirus

      Toxicologist Says Malaria Drugs Show 'Promise' in Treating Coronavirus

      Malaria drugs are showing "promising" initial results as a potential coronavirus treatment, a toxicologist and economic researcher said Saturday.

      Appearing on "Fox & Friends Weekend," Dr. Chris Martenson said the experimental drugs -- including hydroxychloroquine and azithromycin -- were made available on Thursday by the Food and Drug Administration.

      Although chloroquine has a "spotty past" and is unsafe at certain levels, Martenson noted that at the levels used in studies, the drug seems to "be reasonably safe" and works by allowing zinc to stop viruses from replicating.

      In addition, azithromycin could potentially stop secondary infections in damaged lungs, he said.

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      Mentions: Coronavirus
    22. US Hospitals Panic-Buy Drugs Ahead of Coronavirus Influx

      US Hospitals Panic-Buy Drugs Ahead of Coronavirus Influx

      US hospitals are panic-buying drugs as they prepare for an influx of coronavirus patients, risking shortages in antimalarials and inhalers. Wholesale distributors have begun rationing the treatments after sales of chloroquine, an antimalarial that some hope will work against the virus, have spiked by 3,000 per cent so far this month, compared to the same period last year.

      Hospitals have also increased purchases of a related drug with fewer side effects, hydroxychloroquine, by 260 per cent, according to data from Premier, a group representing 4,000 US hospitals.  With no drug available to treat the coronavirus, hospitals are searching for signs in small studies of what might work, and stocking up.

      Chloroquine showed some promising results in studies in ...

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      Mentions: Coronavirus
    23. Sentencing Delay for Doctor Who Illegally Prescribed Opioids

      Sentencing Delay for Doctor Who Illegally Prescribed Opioids

      The coronavirus outbreak has prompted a federal judge to delay the sentencing of a former Delaware doctor convicted of illegally prescribing thousands of powerful prescription painkillers. The judge on Wednesday delayed sentencing for Charles Esham from April 8 to May 8.

      The move came after Esham's lawyer told the judge that he needs to meet with Esham to prepare for sentencing, but that the federal prison in Philadelphia where Esham is being held has indefinitely halted all visits.

      Esham was convicted in December on 39 counts involving conspiracy to distribute and distribution of oxycodone. He faces up to 20 years in prison on each count.

      The former Wilmington physician was indicted in 2017 on one count of conspiracy and ...

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      Mentions: Coronavirus
    24. Generic Drugs Tested in US as Possible Coronavirus Treatments

      Generic Drugs Tested in US as Possible Coronavirus Treatments

      U.S. researchers are looking at two generic prescription drugs to determine whether they could be effective in treating or preventing coronavirus.

      Scientists at the University of Minnesota are testing two drugs, the malaria treatment drug hydroxychloroquine and the blood pressure drug losartan, to see whether either drug is effective in blocking the virus's reproductive processes.

      “We are trying to leverage the science to see if we can do something in addition to minimizing contacts,” Dr. Jakub Tolar, dean of the University of Minnesota's medical school, told Reuters. “Results are likely in weeks, not months.”

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      Mentions: Coronavirus
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