Tag: Chloroquine

  • Brazil recommends chloroquine to treat even mild COVID-19 cases

    Brazil’s health ministry recommended Wednesday using chloroquine and hydroxychloroquine to treat even mild cases of COVID-19, a treatment President Jair Bolsonaro has pushed for despite a lack of conclusive evidence of their effectiveness.

    New federal guidelines released by the ministry recommend doctors prescribe the anti-malarial drugs from the onset of symptoms of coronavirus infection, together with the antibiotic azithromycin.

    Patients will be required to sign a waiver acknowledging they have been informed of potential side effects, including heart and liver problems and retina damage.

    The two medications have been swept up in a politically charged debate amid the pandemic.

    Bolsonaro and his US counterpart Donald Trump, to whom he is often compared, tout them as potential wonder drugs against COVID-19.

    Trump even revealed Monday he has been taking hydroxychloroquine daily as a preventive measure.

    But some studies have cast doubt on the drugs’ effectiveness and safety against coronavirus.

    The health ministry acknowledged that “there are still no meta-analyses of randomized, controlled, blind, large-scale clinical trials of these medications in the treatment of COVID-19.”

    However, it said the government had a responsibility to issue guidelines using the information currently available.

    Preliminary studies of the drugs in China and France showed promising results against COVID-19.

    However, other studies have cast doubt on their effectiveness and raised concerns about the potential for heart, liver and kidney problems, as well as nerve damage.

    Brazil’s former health minister Nelson Teich resigned last week after less than a month on the job, reportedly after clashing with Bolsonaro over the far-right president’s insistence on recommending chloroquine against COVID-19.

    Bolsonaro, who has compared the new coronavirus to a “little flu” and railed against social distancing measures to fight it, fired Teich’s predecessor, Luiz Henrique Mandetta, also after clashing over how to respond to the pandemic.

    Brazil has emerged as the latest flashpoint in the coronavirus pandemic.

    It registered more than 1,000 COVID-19 deaths Tuesday, its highest yet, bringing its total death toll to 17,971.

    The country now has the third-highest number of infections in the world, with more than 270,000, behind only the United States and Russia.

    Source: france24.com

  • Falsified Chloroquine products circulating in Africa FDA

    The Food and Drugs Authority (FDA) has received a notification through the World Health Organisation (WHO) Global Surveillance and Monitoring System for substandard and falsified chloroquine in the WHO region of Africa.

    These chloroquine products with different presentations are confirmed as falsified on the basis that they deliberately or fraudulently misrepresent their composition or source.

    A statement issued in Accra by Delese A. Darko, the Chief Executive Officer, FDA said it was noted that either the products do not contain the correct amount of the active pharmaceutical ingredient, based on the result of preliminary or full compendial analysis.

    “And or the products were not by the manufacturer, whose name was stated on the product labels and varied data (batch number and dates) of the above products do not correspond to genuine manufacturing records,” it said.

    It said it was either the manufacturer name was not stated on the product label does not exist.

    The statement said Chloroquine phosphate or sulfate was referenced on the WHO Model List of Essential Medicines for the treatment of Plasmodium vivax infection (Malaria).

    It said large clinical trials were underway to generate the robust data needed to establish the efficacy and safety of Chloroquine in the treatment of Coronavirus.

    It said these medicines were currently for the treatment of rheumatoid arthritis and lupus diseases and it was important that they were dispensed on prescription only.

    The statement assured the public that their officers in the regions were working to ensure that these products do not enter the supply chains.

     

    Source: GNA

  • Coronavirus fuels a surge in fake medicines

    Growing numbers of fake medicines linked to coronavirus are on sale in developing countries, the World Health Organization (WHO) has warned.

    A BBC News investigation found fake drugs for sale in Africa, with counterfeiters exploiting growing gaps in the market.

    The WHO said taking these drugs could have “serious side effects”.

    One expert warned of “a parallel pandemic, of substandard and falsified products”.

    Around the world, people are stockpiling basic medicines. However, with the world’s two largest producers of medical supplies – China and India – in lockdown, demand now outstrips the supply and the circulation of dangerous counterfeit drugs is soaring.

    In the same week the World Health Organization (WHO) declared coronavirus a pandemic last month, Operation Pangea, Interpol’s global pharmaceutical crime fighting unit, made 121 arrests across 90 countries in just seven days, resulting in the seizure of dangerous pharmaceuticals worth over $14m (£11m).

    From Malaysia to Mozambique, police officers confiscated tens of thousands of counterfeit face masks and fake medicines, many of which claimed to be able to cure coronavirus.

    “The illicit trade in such counterfeit medical items during a public health crisis, shows a total disregard for people’s lives,” said Interpol’s Secretary General Jurgen Stock.

    According to the WHO, the broader falsified medicines trade, which includes medicines which may be contaminated, contain the wrong or no active ingredient, or may be out-of-date, is worth more than $30bn in low and middle-income countries.

    “Best case scenario they [fake medicines] probably won’t treat the disease for which they were intended”, said Pernette Bourdillion Esteve, from the WHO team dealing with falsified medical products.

    “But worst-case scenario they’ll actively cause harm, because they might be contaminated with something toxic.”

    The supply chain

    The global pharmaceutical industry is worth more than $1 trillion. Vast supply chains stretch all the way from key manufacturers in places such as China and India, to packaging warehouses in Europe, South America or Asia, to distributors sending medicines to every country in the world.

    There is “probably nothing more globalized than medicine,” said Esteve. However, as the world goes into lockdown, the supply chain has already begun to uncouple.

    Several pharmaceutical companies in India told the BBC they are now operating at 50-60% of their normal capacity. As Indian companies supply 20% of all basic medicines to Africa, nations there are being disproportionately affected.

    Ephraim Phiri, a pharmacist in Zambia’s capital Lusaka, said he was already feeling the strain.

    “Medicines are already running out and we are not replenishing them. There is nothing we can do. It’s been really hard to get supplies… especially essential medicines like antibiotics and antimalarials.”

    Producers and suppliers are also struggling as the raw ingredients to manufacture tablets are now so expensive, some companies can simply not afford to keep going.

    One producer in Pakistan said he used to buy the raw ingredients for an antimalarial drug called hydrochloroquine for about $100 a kilo. But today, the cost has increased to $1,150 a kilo.

    With an increasing number of countries going into lockdown, it’s not only the reduction in production that’s problematic, it’s also the increase in demand, as people around the world anxiously stockpile basic medicines.

    It’s this unstable combination of reduced supply and increased demand that has led the WHO to warn of a dangerous spike in the production and sales of fake drugs.

    “When the supply does not meet the demand,” said Esteve, from the WHO, “it creates an environment where poorer quality or fake medicines will try to meet that demand.”

    Fake medicine

    Speaking to pharmacists and drug companies around the world, the global supply of antimalarials is now under threat.

    Ever since US President Donald Trump began referring to the potential of chloroquine and a related derivative, hydroxychloroquine, in White House briefings, there has been a global surge in the demand for these drugs, which are normally used to tackle malaria.

    Coronavirus and chloroquine: Is there evidence it works?

    The WHO has repeatedly said there is no definitive evidence that chloroquine or hydroxychloroquine can be used against the virus that causes COVID-19. However, at a recent news conference, whilst referring to these antimalarials, President Trump said: “What do you have to lose? Take it.”

    As the demand has soared, the BBC has discovered large quantities of fake chloroquine in circulation in the Democratic Republic of Congo and Cameroon. The WHO has also found fake medicines for sale in Niger.

    The antimalarial chloroquine is normally sold for about $40 for a pot of 1,000 tablets. But pharmacists in the DRC were found to be selling them for up to $250.

    The medicine being sold was allegedly manufactured in Belgium, by “Brown and Burk Pharmaceutical limited”. However, Brown and Burk, a pharmaceutical company registered in the UK, said they had “nothing to do with this medicine. We don’t manufacture this drug, it’s fake.”

    As the coronavirus pandemic continues, Professor Paul Newton, an expert in fake medicines at the University of Oxford, warned the circulation of fake and dangerous medicines would only increase unless governments around the world present a united front.

    “We risk a parallel pandemic, of substandard and falsified products unless we all ensure that there is a global co-ordinated plan for co-ordinated production, equitable distribution and the surveillance of the quality of the tests, medicines and vaccines. Otherwise the benefits of modern medicine… will be lost.”

    Source: bbc.com