Take-at-home COVID drug molnupiravir may be on its way — but vaccination is still our first line of defence

Nial Wheate, University of SydneyThe Australian government has pre-purchased 300,000 courses of an experimental antiviral oral drug called molnupiravir.

Interim results announced by the company, US pharmaceutical Merck, show the drug halved the number of patients who ended up in hospital due to COVID. No patient who took the drug died from the virus.

But the drug isn’t yet available for dispensing from pharmacies because it hasn’t received approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA).

If approved it can be used in the community to prevent patients with mild symptoms from developing more severe disease.

Until then, there will be no legal, effective and safe treatments that people with COVID can take at home to keep them out of hospital. As such, we need to continue our push to get maximum vaccination coverage within the community.

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What is molnupiravir?

Molnupiravir is an experimental antiviral drug that acts against a range of respiratory viruses, including the virus that causes COVID.

For COVID, the instructions for creating more virus are contained in the virus’ RNA. This RNA needs to be read and copied to make new virus particles.

Molnupiravir works by disrupting the replication of the virus. It does this by mimicking two natural compounds called cytidine and uridine that are needed to make RNA. When the body tries to replicate the virus it incorporates molnupiravir into the RNA structure instead of versions of cytidine and uridine. The result is the accumulation of mutations in the virus RNA which then prevent it from causing illness.

This type of technology isn’t new. In fact, we have been using chemotherapy drugs that mimic RNA and DNA ingredients for over 50 years. One drug, called fluorouracil works by preventing DNA production inside cancer cells by mimicking the DNA ingredient thymine.

Results of the clinical trial

Last week Merck announced interim results of a phase 3 clinical trial of molnupiravir.

The company found the drug significantly reduced the risk of hospitalisation or death in patients who took the drug when compared with patients who took a placebo treatment. In fact, the results were so good, an independent data monitoring committee recommended the trial be stopped early.

Overall, the drug reduced hospitalisations and deaths by around 50%. While 14.1% of patients who took placebo ended up in hospital, only 7.3% of molnupiravir patients had the same outcome.

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The results were even better with regard to the death rates. No patient who took molnupiravir died, while eight patients in the placebo group did die.

Importantly, while the clinical trial demonstrated efficacy of the drug, it was also able to show molnupiravir is safe. The rate of side effects was nearly the same in both the molnupiravir and placebo groups. Earlier clinical trials found there are no serious side effects with the drug. The most common, mild effects were headache and diarrhea.

We have to wait for the full data to be released and checked in order to be fully confident in the drug. But the results seem to indicate molnupiravir may be useful for the early treatment of COVID to prevent the development of serious disease and hospitalisation.

How it will be used

Molnupiravir will be able to be taken orally by patients at home after they receive a prescription from their doctor.

A course of treatment will be eight 200 milligram capsules a day for five days; four capsules in the morning and four capsules in the afternoon. A patient can choose whether they want to take the medicine with or without food, as it doesn’t appear to affect the medicine in the body.

It’s unclear whether a positive COVID test will be required before a prescription can be issued. This is something that will be decided by the TGA.

Health Minister Greg Hunt said he encourages Merck to apply for registration of the drug, and the TGA has stated it’s willing to receive an application for provisional registration at which time they can evaluate the data themselves.

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Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Coronavirus Treatment

What is sotrovimab, the COVID drug the government has bought before being approved for use in Australia?

Shutterstock

Elise Schubert, University of Sydney; Lifeng Kang, University of Sydney, and Nial Wheate, University of SydneyAustralia currently has drugs that treat the symptoms of COVID, and drugs which have been repurposed from other diseases. Now the government has placed an early order for a new drug, sotrovimab, which works on COVID-19 virus particles in the body.

The federal government has bought 7,700 doses of sotrovimab (pronounced so-tro-ve-mab), with an initial delivery due some time this year.

But the COVID-19 Clinical Evidence Taskforce says the clinical trial results are too preliminary for the drug to enter routine use here. The taskforce says until further evidence shows sotrovimab is effective, it should only be given to patients as part of a human clinical trial.

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What type of drug is it?

Sotrovimab is a newly developed monoclonal antibody-based medicine. This means it stops the action of the virus that causes COVID-19.

Antibodies are a type of protein in the immune system. Antibodies can recognise and attach to another type of protein called an antigen.

When an antibody attaches to the antigen, it triggers a series of reactions, which can be used to treat an associated disease.

Monoclonal antibody drugs are used for other conditions.
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Monoclonal antibody drugs are already established in modern medicine and are used to treat diseases such as arthritis and cancer.

Another monoclonal antibody drug called tocilizumab is used to treat some of the inflammatory symptoms associated with COVID-19.

How does sotrovimab treat COVID?

Sotrovimab works by binding to the spike protein on the outside of the COVID-19 virus. This is the same spike protein the body’s immune system is trained to recognise with the Pfizer COVID vaccine.

By binding to the spike protein, sotrovimab can block the virus from attaching to and entering human cells. This stops the virus replicating in the body.

How is sotrovimab given and what are the side effects?

The US Food and Drug Administration has approved sotrovimab for emergency use as an intravenous injection to treat COVID-19 patients at high risk of progressing to severe disease.

Sotrovimab can be given as soon as someone receives a positive test result or within ten days of getting COVID-19 symptoms.

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The most common side effects with sotrovimab are rash and diarrhoea. Patients also need to be closely monitored for severe allergic reactions after the injection.

What have clinical trials shown so far?

In May 2021, pharmaceutical company GlaxoSmithKline released data from a clinical trial. It compared sotrovimab to a placebo in 583 at-risk COVID-19 patients to see whether it prevented the disease progressing to the extent that the patient needed to be hospitalised or died.

In the sotrovimab group (of 291 people), three patients saw their disease progress, compared to 21 in the placebo group (of 292 people). This amounts to an 85% reduction of disease progression in patients with mild to moderate COVID-19.

Has it been approved by medical regulators?

In May, both the US and European drug regulators authorised sotrovimab to be used in adults and children aged over 12 with mild to moderate COVID-19, but who are at a high risk of progression to severe COVID-19. This includes people aged over 65, and those with certain medical conditions such as heart disease, obesity, asthma, and diabetes.

Australia’s regulator, the Therapeutic Goods Administration (TGA), has received an application from GlaxoSmithKline to provisionally register the drug here in Australia, however its use remains limited to research settings.

So far, sotrovimab can only be used in research settings in Australia.
Shutterstock

So what does that mean for Australia?

Yesterday federal health minister Greg Hunt announced the government had purchased 7,700 dose of sotrovimab, based on the recommendation of its Science and Industry Technical Advisory Group.

The intention is to have the drug ready for use once approved by the TGA.

But the COVID-19 Clinical Evidence Taskforce, which creates clinical guidelines for the treatment of people with COVID-19 in Australia, has concerns about “the impact of sotrovimab on patient-relevant outcomes in the treatment of COVID-19” and the potential harms of unproven treatment.

It says sotrovimab should not be used outside randomised human clinical trials that have the appropriate ethical approval:

Trials are needed in special populations, including children and adolescents, pregnant and breastfeeding women, older people living with frailty and those receiving palliative care. Until further evidence is available, do not use sotrovimab for the treatment of COVID-19 in these populations unless they are eligible to be enrolled in trials.

As such, sotrovimab can only enter mainstream use in Australia when the full results of the phase 3 clinical trials are known. That data will be important for the TGA to determine whether the drug works, and whether it’s better than the current treatments.

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Elise Schubert, Pharmacist and PhD Candidate, University of Sydney; Lifeng Kang, Senior Lecturer, University of Sydney, and Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Multiple sclerosis drug may help treat COVID-19 and lead to faster recovery

Vadim Zakharishchev/Shutterstock

Nial Wheate, University of Sydney and Elise Schubert, University of Sydney

What do multiple sclerosis (MS) and the novel coronavirus have in common? Until this week, not much, but a recent clinical trial has shown a reformulation of a drug used to treat MS can potentially also be used to help patients infected with COVID-19.

SNG001 is an inhaled form of a drug called interferon-beta under development by the UK pharmaceutical company Synairgen. Interferon is normally prescribed for the treatment of symptoms relating to relapsing-remitting MS.

But the clinical trial, Synairgen found that when SNG001 was given to patients with COVID-19, it stopped the development of more severe symptoms, accelerated their recovery, and allowed them to leave hospital earlier.

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Like other clinical trials for COVID-19 treatments, the results still need to be thoroughly checked before SNG001 is included as a standard treatment for coronavirus. The drug’s key risks (potential for severe depression) also need to be weighed against the potential benefits.

How does it work?

MS is a condition of the central nervous system. The nerve impulses between the brain and spinal cord get blocked or mixed up. It happens because the body’s immune system attacks the protective layers around nerve fibres. The result is a loss of muscle control and balance.

In contrast, COVID-19 is a viral infection that affects a patient’s ability to breathe due to inflammation putting pressure on their lungs.

What both diseases have in common is the activation of the body’s immune response, so a drug that modulates the immune system for one can potentially work for the other.

Interferon-beta (interferon), a naturally occurring protein in the body, is used as an immunotherapy drug to combat relapsing-remitting MS by reducing inflammation and easing the symptoms of the disease.

Scientists at Synairgen hypothesised it could also treat COVID-19 through initiating the body’s antiviral response and potentially reducing inflammation on the lungs.

It is believed some at-risk patient groups cannot produce interferon as effectively as other people, reducing their ability to fight the virus and resulting in more severe symptoms.

So giving those patients interferon, in theory, should help them fight the virus, alleviate their symptoms, and improve survival rates.

Take a breath

For the treatment of MS, interferon is given as a weekly injection into muscle tissue.

The SNG001 drug developed by Synairgen contains the same interferon therapy used for MS, but formulated as an inhaled product.

Originally, the company was developing SNG001 as a treatment for a different type of lung condition called chronic obstructive pulomary diease (COPD), but it saw the direct potential for COVID-19 as well.

Instead of an injection, SNG001 is given to patients via a nebuliser, a machine that transforms a water solution of interferon into a fine mist that can be breathed in by patients through a face mask.

Promising results, so far

Between March and May this year, Synairgen sponsored a clinical trial at University Hospital Southampton to test SNG001 for COVID-19 patients. Those eligible for the trial only needed to have mild symptoms of COVID-19.

Other clinical trials conducted in the past for different drugs, such as remdesivir and dexamethasone, required patients to be hospitalised before they were eligible for drug treatment.

In total, 101 patients in a hospital setting were enrolled in the SNG001 trial and were given the drug daily for 14 days. Compared with a placebo, those given SNG001 had a 79% lower risk of developing severe disease.

Patients given the drug were also twice as likely to recover from their infection and were discharged earlier from hospital than those given the placebo.

Before SNG001 becomes standard care for COVID-19 treatment the results of the clinical trial need to be checked by independent scientists.

In the past, trial results for hydroxychloroquine did not stand up to scrutiny after they were announced and the results were subsequently retracted by the research team.

The risks and benefits

If the latest results are shown to be reliable, before doctors decide to make SNG001 a part of the standard treatment for hospitalised COVID-19 patients they will need to weigh its benefits against the potential risks.

One of the most important side effects of the drugs is that it can induce depression.

As a result, interferon is used with caution in patients with pre-existing depression or who have suicidal thoughts. These conditions may already be heightened by the pandemic if a potential patient for the drug has lost their job or they are not dealing well with the isolation of social distancing.

This means doctors would need to undertake a comprehensive mental health screen of all patients they consider for SNG001 treatment.

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Other side effects relevant to interferon are that it can worsen seizure disorders or heart failures. So again, it needs to be used with caution in these patient groups.

The results of the SNG001 trial are very promising and potentially give us a treatment to prevent those people mildly infected with COVID-19 from developing more severe symptoms and needing hospitalisation.

But the results need to be checked by independent scientists first, and the drug’s benefits need to be weighed against its risk, as the ability to induce severe depression could cause a wave of mental health problems that make matters worse rather than better.

Nial Wheate, Associate Professor | Program Director, Undergraduate Pharmacy, University of Sydney and Elise Schubert, Pharmacist and PhD Candidate, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Dexamethasone: the cheap, old and boring drug that’s a potential coronavirus treatment

Nial Wheate, University of Sydney

First, we tried the antimalarial drug hydroxychloroquine. Then we tested the antiviral drug remdesivir. But new UK research gives the strongest indication yet we may have found a useful treatment for COVID-19.

This time it’s an old anti-inflammatory drug, dexamethasone, which has been described as cheap, old and boring.

Preliminary results from a clinical trial just released indicate the drug seems to reduce your chance of dying from COVID-19 if you’re in hospital and need oxygen or a machine to help you breathe.

The results were significant enough for the UK to recommend its use for severe COVID-19.

Before we roll it out in Australia, we need to balance the drug’s risks with its benefits after peer-review of the full trial data.

What is dexamethasone?

Dexamethasone has been used since the late 1950s, so doctors are familiar with it. It’s also inexpensive, with a packet of 30 tablets costing around A$22 (for general patients) under Australia’s Pharmaceutical Benefits Scheme.

So if it does work for COVID-19, this cheap and boring drug, already available in Australia with a prescription, would be easy to add to current treatments.

Dexamethasone belongs to a class of drugs known as corticosteroids and is used to treat a range of conditions related to inflammation. These include severe allergies, some types of nausea and vomiting, arthritis, swelling of the brain and spinal cord, severe asthma, and for breathing difficulties in newborn babies.

And it’s dexamethasone’s application to those latter two respiratory conditions that prompted doctors to think it may also help patients severely affected by COVID-19.

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What did the trial find?

The recently reported results come from the Randomised Evaluation of COVID-19 Therapy, or RECOVERY, trial.

The researchers put patients into one of three groups: those needing ventilation (a machine that helps them breath); those who just needed oxygen therapy; and those who needed no treatment to help them breathe.

Patients in each of those groups were given dexamethasone (6mg once a day, either as a tablet or via intravenous injection), for ten days. A fourth group (a control group) was not given the drug.

Dexamethasone was most useful for the ventilated patients; deaths for this group dropped by about one-third with drug treatment. In contrast, deaths only dropped by one-fifth for those patients who were only receiving oxygen therapy. There was no benefit to patients who could breathe normally.

Results of the dexamethasone trial have just been released.

The researchers calculated that giving dexamethasone to eight ventilated patients would prevent one from dying, on average. And giving it to around 25 patients needing oxygen alone would prevent one death.

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How might dexamethasone work for COVID-19?

When a patient has severe COVID-19, their immune system ramps up to catch and control the virus in the lungs.

In doing this, their body produces more infection-fighting white blood cells. This results in inflammation and pressure on their lungs, making it very difficult for them to breath.

It’s therefore likely dexamethasone reduces this inflammation, and so reduces pressure on the lungs.

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What are the downsides?

There are potential complications with using dexamethasone.

First, dexamethasone also suppresses the immune system when it reduces inflammation. So, it’s not usually recommended for people who are sick, or could be sick, from other infections. So doctors will need to make sure patients have no other infections before they are prescribed the drug.

If the results of this trial are correct though, the drug doesn’t appear to compromise the patient’s ability to fight COVID-19; it might just affect their ability to fight off other diseases.

Second, the drug is only useful for patients with difficulty breathing and needing some assistance either through ventilation in a hospital or from oxygen therapy.

There appears to be no benefit for patients who don’t need help breathing. So we shouldn’t be giving it to everyone who tests positive to the virus.

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Third, like all drugs, dexamethasone has side effects that need to be monitored. Serious, but rare ones include: severe stomach or intestinal pain, sudden changes with vision, fits, significant psychiatric or personality changes, severe dizziness, fainting, weakness and chest pain or irregular heartbeat, and swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing.

What happens next?

The results of the clinical trial are preliminary. So we need to wait for the full study data and scientific peer-review before we can make a definitive decision as to whether dexamethasone treatment is a worthwhile, and safe, addition to COVID-19 therapy in Australia.

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Nial Wheate, Associate Professor | Program Director, Undergraduate Pharmacy, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Is remdesivir a miracle drug to cure coronavirus? Don’t get your hopes up yet

Nial Wheate, University of Sydney and Andrew Bartlett, University of Sydney

The race is on to find a drug that is both effective and safe for treating COVID-19, which has spread to 3.1 million infections and caused 220,000 deaths worldwide.

This week, the US National Institute of Allergy and Infectious Diseases released findings of a clinical trial of the experimental antiviral drug remdesivir. This showed COVID-19 patients recovered more quickly and had an improved survival rate when taking the drug, compared with those given a placebo and standard care.

But these are just the preliminary results of one study. Other human trials have not shown similar results. Further trials are under way and will more definitively show whether remdesivir is a suitable and effective treatment for COVID-19.

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In the fight against coronavirus, antivirals are as important as a vaccine. Here’s where the science is up to

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What is remdesivir?

Remdesivir is an experimental antiviral drug being developed by Gilead Sciences. Originally it was being developed as a treatment for Ebola, a viral infection that causes severe internal bleeding. But researchers are now interested in its potential to treat patients with COVID-19.

Remdesivir mimics a natural ingredient called adenosine of DNA and RNA, the latter being a molecule similar to DNA that is used to carry the genetic information of viruses. After the drug is activated in the body, it works by blocking a type of enzyme called a polymerase, which is needed to make DNA and RNA.

When you block the enzyme, the virus can’t make copies of itself, limiting the development of symptoms and spread of the disease.

It should be noted that no drug is perfectly safe, and remdesivir is no different. Studies undertaken so far suggest the drug may damage the liver and cause other short-term side effects such as nausea and vomiting.

These side effects need to be taken into consideration when treating COVID-19 patients who have other underlying conditions.

Clinical trials in US positive but only preliminary

This week the National Institute of Allergy and Infectious Diseases (NIAID) released the results of its trial using remdesivir for COVID-19 patients. They studied the effects of the drug on patients who were already infected with COVID-19 to see whether it helped them recover faster and improve their survival rate.

Adult patients hospitalised with COVID-19 were given daily injections of remdesivir. They were found to recover four days faster, an improvement of 31%, when compared with other patients who only received standard care and placebo.

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The results also indicated that more patients survived the infection with remdesivir treatment, with the death rate dropping from 11.6% to 8%.

The results are significant enough that director of NIAID Anthony Fauci said it was an “ethical responsibility” for the remaining trial patients who were taking the placebo to be switched to the active drug.

But we need to treat the results of this trial with caution; for the moment they are only preliminary.

A data and safety panel has looked at the initial results, but they haven’t been peer-reviewed. During peer review, independent experts from the scientific community scrutinise the study design, methods, data produced, and the conclusions before the study is published in a medical journal.

How does it compare with other studies?

The results of other trials, such as one undertaken in China, have not shown the same promising results.

The Chinese study was published in the Lancet, considered one of the most influential medical journals in the world. This trial was a randomised, double-blind, placebo-controlled study which means that neither the researchers nor the patients knew if they’d been given the active drug or a placebo.

These types of studies can reduce some biases that can influence studies, but also help quantify the effectiveness of the drug.

But the study also had limitations that need to be recognised. The patients were not as seriously ill as those in the NIAID trial, and the study was terminated early because the outbreak in China was easing.

In the end, the study only collected data on 237 patients, compared with 1,063 patients in the NIAID trial. The authors acknowledge further study is needed in more seriously ill patients and with a larger sample size.

Currently there are more than a dozen other clinical trials of remdesivir and COVID-19 being undertaken throughout the world. We need to await the data to know for sure whether the drug is as effective as we need it to be.

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This article is supported by the Judith Neilson Institute for Journalism and Ideas.

Nial Wheate, Associate Professor | Program Director, Undergraduate Pharmacy, University of Sydney and Andrew Bartlett, Associate Lecturer Pharmacy Practice, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Four of the most life-threatening skin conditions and what you should know about them

Some serious skin conditions are more likely to affect those with weaker immune systems.
from http://www.shutterstock.com

William Cranwell, Melbourne Health

This article is part of our series about skin: why we have it, what it does, and what can go wrong. Read other articles in the series here.

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Dermatological emergencies are uncommon, but can cause devastating complications and death if not recognised and treated early. Some skin conditions require treatment in an intensive care unit. Here are some of the most serious skin conditions and what you should know about recognising them.

1. Necrotising fasciitis

Necrotising fasciitis is a severe infection of the skin, the tissue below the skin, and the fascia (fibrous tissue that separates muscles and organs), resulting in tissue death, or necrosis. The infection is rapid, fast-spreading and fatal if not detected and treated early. If not treated with antibiotics and surgery early, toxic shock and organ failure are common.

Necrotising fasciitis may occur in anyone. Previously healthy young people are often affected.

The cause may be one or more bacteria entering the body via an external injury or punctured internal organ. Group A streptococci bacteria, which are the organisms implicated in “strep throat”, are among the most common causes.

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Explainer: what causes necrotising fasciitis, the flesh-eating bug?

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Early necrotising fasciitis is easily missed, as similar symptoms are commonly seen in less severe infection. The initial area is painful, red and swollen. This progresses to a dark, blistered, malodorous and blackened area, which is a sign of tissue death. Other symptoms include fever, intense pain, low blood pressure and shock.

The most important risk factors for necrotising fasciitis include diabetes, peripheral vascular disease, trauma, alcohol and intravenous drug use, and use of non-steroidal anti-inflammatory drugs.

Treatment of necrotising fasciitis is immediate hospitalisation, surgical removal of all dead tissue, and intravenous antibiotics. Patients often require intensive care. Management of shock and other complications reduces the risk of death. Use of a hyperbaric chamber (to increase oxygen delivery to the tissue) and immune therapy may also be required.

Around a quarter of people diagnosed with necrotising fasciitis will die, and sepsis occurs in up to 70% of cases.

Most have heard of necrotising fasciitis as the ‘flesh-eating bug’.
DermNet New Zealand

2. Scalded skin syndrome

Staphylococcal scalded skin syndrome is an uncommon major skin infection. It typically affects newborn babies, young children and adults with reduced immune systems or kidney failure. This syndrome is caused by toxins produced by the bacterium Staphylococcus aureus, which is common in throat, ear and eye infections.

Around 15-40% of adults carry Staphylococcus aureus on the skin surface and have no problems. But these adults may inadvertently introduce the bacteria into nurseries or daycare centres. Because young children have weak immunity to specific toxins, they’re at increased risk of scalded skin syndrome.

Scalded skin syndrome is characterised by a red, blistering rash resembling burns. Early symptoms include fever, skin redness and skin tenderness. Other symptoms may include sore throat or conjunctivitis.

Within 24-48 hours, fluid-filled blisters form on the entire body. The blisters may rupture, leaving areas resembling burns. Large areas of the skin peel off and fall away with only minor touch.

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Common skin rashes and what to do about them

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Scalded skin syndrome requires hospitalisation for intravenous antibiotics and treatment of the wounds. Ruptured blisters require wound dressings, and the skin surface requires intense care to avoid further damage.

Other treatment includes intravenous fluid and electrolyte maintenance to prevent shock and other complications, paracetamol for pain and fever, and avoidance of severe sepsis. Sepsis is when chemicals released into the bloodstream to fight an infection trigger inflammatory responses throughout the body, which can be life-threatening.

Complications of scalded skin syndrome include severe infection, pneumonia, cellulitis (a bacterial skin infection) and dehydration. Most children treated appropriately recover well and healing is complete within a week.

Staphylococcal scalded skin syndrome is more likely to occur in people with weaker immune systems – such as children.
DermNet New Zealand

3. DRESS syndrome

Standing for “drug reaction with eosinophilia and systemic symptoms,” DRESS syndrome is a severe reaction that affects the skin and internal organs. The patient may have an extensive rash, fever, enlarged lymph nodes and damage to the liver, kidneys, lungs, heart, blood components or pancreas. Symptoms usually start two to eight weeks after the responsible drug has been taken.

The death rate is estimated between 10 and 20%, most often due to liver failure.

The most common drugs responsible include anticonvulsants, antidepressants, non-steroidal anti-inflammatory drugs, antibiotics and sulfa drugs (a type of synthetic antibiotic). The severe reaction is thought to occur due to a pre-existing genetic change in the immune system, a triggering illness (most often a viral infection) and defective breakdown of the drug by the body.

Early diagnosis is essential. The responsible drug must be stopped immediately and patients may require intensive care or burn unit management. More intensive treatment is needed if organs are involved.

DRESS syndrome appears a few weeks after taking a drug the patient is allergic to.
DermNet New Zealand

4. Life-threatening drug reactions

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are variants of a life-threatening reaction that affects the skin and mucous membranes (mouth, eyes, genitals, respiratory or gastrointestinal tracts).

These are unpredictable reactions that leave sufferers critically unwell, with widespread death of the outer skin layer (epidermis), which peels off. The rash generally begins on the trunk and extends to the limbs and face, and there is intense skin pain. Before the rash appears, symptoms include fever, sore throat, runny nose, conjunctivitis and general aches.

It’s almost always caused by medications. The most common medications causing this reaction are anticonvulsants, antibiotics, allopurinol (gout medication), non-steroidal anti-inflammatory drugs and an HIV drug. The reaction usually occurs in the first eight weeks after taking the drug. It’s more likely to happen if the patient has cancer, HIV or specific genes that may play a role.

This reaction can be fatal by causing dehydration and malnutrition, severe infection, respiratory failure, gastrointestinal complications and multi-organ failure.

The responsible drug has to be stopped, and treatment (in a burns unit and intensive care unit) includes wound care, fluid management, pain management and prevention of infection. Long-term complications, including scarring, eye, oral, genital, lung disease and mental health disorders, are common. Around a quarter of people with this reaction will die.

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The skin is a very important (and our largest) organ: what does it do?

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This reaction to medications is totally unpredictable.
DermNet NZ

William Cranwell, Dermatology Clinical Research Fellow, Melbourne Health

This article was originally published on The Conversation. Read the original article.

Pakistan’s Drug War

Suspected Drug Traffickers Kidnap Pastor

Michoacan state church leader abducted during Sunday service.

MEXICO CITY, April 15 (CDN) — Some 500 worshippers were gathered for last Sunday’s (April 10) worship service at the Christian Center El Shaddai in the Mexican city of Lázaro Cárdenas, Michoacan at about 8:15 a.m. when four masked men burst in firing machine guns into the air.

Before the frightened believers realized what was happening, their pastor, Josué Ramírez Santiago, had been whisked away. Divergent press reports indicated the kidnappers, suspected drug traffickers active in the state, were about 10 in number.

The following day, the pastor’s family received news that the criminals wanted a ransom of 20 million pesos (US$1.7 million). Even if the family could raise such an immense sum – considered doubtful – payment would not guarantee that the victim would be returned alive.

Arturo Farela, director of the National Fraternity of Evangelical Churches, has asserted that organized crime syndicates and drug cartels have targeted Christians because they view churches as revenue centers and because churches support programs for the rehabilitation of drug addicts and alcoholics.

“The majority of rehabilitation centers that have been attacked by organized crime in Ciudad Juarez, Tijuana, Tepic and other places belong to the evangelical community,” Farela said in a declaration regarding the kidnapping of Ramirez. “Furthermore, some 100 Mexican or foreign pastors who lived in Ciudad Juarez have had to abandon the city because of the threats and demands for money. And of course many pastors and their families have been victims of extortion, threats, kidnapping and homicide.”

Farela has stated that 100 Mexican clergymen have been kidnapped in recent years, with 15 of them losing their lives to organized crime. Asked if Compass could review his records of these crimes, Farela said he was not authorized to permit it.

In numerous other cases, children of pastors have been kidnapped, including one from Matehuala, San Luis Potosi, who has not been heard from for some six months. The college-age daughter of a prominent pastor in Mexico City was held by kidnappers for a week but was released when the criminals grew tired of the father’s prayers every time they telephoned him; the family has not revealed whether money was given for her return.

Michoacan, the state where the most recent abduction took place, has been a center of much criminal activity and also of severe reprisals by elements of the Mexican army. The state where President Felipe Calderon was born, Michoacan was the first to implement an anti-drug military operation that expanded to northern and eastern states.

In spite of the operation, more than 34,600 people nationwide have reportedly been assassinated since it was implemented in December 2006, with most of those crimes tied to drug traffickers “settling accounts.”

Report from Compass Direct News
http://www.compassdirect.org

Unprecedented Appearance of Foreign Evangelist in Vietnam

Luis Palau preaches at Protestant centennial in spite of government putting up obstacles to event.

HO CHI MINH CITY, Vietnam, April 11 (CDN) — The first appearance by a U.S.-based evangelist preaching at a major event since the 1975 communist victory in Vietnam helped the country’s Protestants to celebrate their centennial last weekend after government officials gave last-minute approval.

In what seems to have become standard government procedure in Vietnam, permission requested months in advance was granted – at a venue several kilometers from the one organizers sought – just three hours before the first major celebration of the Centennial of Protestantism in Vietnam (1911-2011) at Thanh Long Stadium in Ho Chi Minh City on Saturday (April 9) was scheduled to begin. Argentine-born Luis Palau, who has preached in person to 28 million people in 72 countries, delivered the gospel
message.

A second night of celebration began at 7 p.m. on Sunday.

The venue change meant equipment staged in one part of the city had to be moved to the new location before it could be assembled, church leaders said. It also meant notifying many thousands of people invited to one venue about the change to the other, they said.

Given the lack of government cooperation, the leader of Vietnam’s Evangelical Fellowship (of house churches) said the fact that the event went ahead at all was “an absolute miracle.”

By word-of-mouth, Internet, Twitter, Facebook, and especially phone texting, thousands of people got word of the change as technicians and hundreds of volunteers made heroic efforts to ready the stadium. Vietnamese police proved surprisingly helpful in redirecting people from the original site to the new location.

At 9 p.m. – two hours after the schedule start – huge banners reading “PRAY FOR VIETNAM” and “GOD LOVES VIETNAM” were unfurled to welcome the Luis Palau Team and thousands of people to the festival, which joyfully combined the centennial celebration with Easter.

After opening prayers and welcome by Vietnamese leaders, Palau’s son Andrew Palau gave testimony to how God delivered him from alcoholism and drug addiction and called him to Christian service. An Intel Corp. vice-president also gave testimony to how God blessed his life and his business. Pastor-musician Don Moen, known for songs such as “Give Thanks,” “God is so Good,” and “God will Make a Way,” provided inspirational music followed by exuberant congregational singing.

Palau began his message at 11 p.m., delivering a concise and clear evangelistic sermon, and about 800 came forward as he invited people to receive Christ. It was after midnight before people began to depart for their homes.

The second celebration proceeded Sunday evening (April 10) in a more orderly and timely fashion. More than 12,000 people filled the seats and most of the chairs set up on the stadium field. In response to Palau’s second message, more than 1,000 people, according to one organizer, came forward in response to the call to follow Christ.

Photos and Vietnamese text on the events are readily available at http://www.hoithanh.com, and clips of the arrival of Palau and Moen in Vietnam may be found on YouTube. They were welcomed at Ho Chi Minh City’s Tan Son Nhut airport by hundreds of enthusiastic young people carrying banners and flowers.

Dr. Nguyen Xuan Duc, president of the Vietnam World Christian Fellowship, said he was very encouraged about the future of the church in Vietnam.

“These are watershed days for Protestantism in Vietnam,” he said. “There is no fear, but rather wonderful spontaneity and irrepressible joy. Events like this happen in spite of the government and without the blessing of some overly conservative church leaders. What we see is young, vibrant, lay-led, internationally connected and very media-savvy.”

While Moen, Palau and others spoke on Sunday night, also appearing in Ho Chi Minh City was iconic singer/songwriter Bob Dylan – whose performance sold only about half of the 8,000 seats at RMIT university.

A week before in Beijing, censors who reviewed Dylan’s song list allowed an unabashedly Christian song beginning, “Jesus said be ready for you know not the hour in which I come,” but did not allow “Blowin’ in the Wind” and “The Times They Are A-Changin’,” according to The Associated Press. Brad Adams of Human Rights Watch complained that, in an earlier day, Dylan – whose music contributed to opposition to the Vietnam War – would never have let a government tell him what to sing, according to the AP.  

Vietnamese organizers and the Palau team now travel north to Hanoi for similar events on Friday and Saturday (April 15-16). As yet there is no indication whether authorities there will be more accommodating than they were in Ho Chi Minh City.

Report from Compass Direct News
http://www.compassdirect.org