What is Hydroxychloroquine, the drug recommended by ICMR?

The ICMR on Monday recommended the use of hydroxychloroquine for the treatment of the novel coronavirus for two categories of ‘high risk population’. The drug, that has existed for several decades, has been recommended for prophylaxis in case of asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory confirmed cases.

What is Hydroxychloroquine?
Hydroxychloroquine (not to be confused with anti-malaria drug chloroquine) is an oral medication used in the treatment of autoimmune diseases such as rheumatoid arthritis. The use of the drug gained traction after US President Donald Trump tweeted on March 21 about the use of a cocktail of hydroxychloroquine-

azithromycin as a “big game-changer in the history of medicine”.

However, an article in The Lancet Global Health on March 19 had explored its therapeutic and prophylactic properties. “Notably, the drug shows antiviral activity in vitro against coronaviruses, and specifically, SARS-CoV-2 [the virus that causes COVID-2]. Pharmacological modelling based on observed drug concentrations and in vitro drug testing suggest that prophylaxis with hydroxychloroquine at approved doses could prevent SARS-CoV-2 infection and ameliorate viral shedding.”

In the United States, several clinical trials of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection are planned or will be enrolling soon.

Explained: Here’s why hydroxychloroquine is no silver bullet

In India, the National Taskforce for COVID-19 set up by ICMR issued guidelines for the use of Hydroxychloroquine, which read: “Hydroxy-chloroquine is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from available evidence of benefit as treatment and supported by pre-clinical data… The following recommendation… is based on these considerations, as well as risk-benefit consideration, under exceptional circumstances that call for the protection of high-risk individuals.”

The two categories, namely, ‘Asymptomatic Healthcare Workers’ and ‘Asymptomatic household contacts’ of laboratory-confirmed cases have been advised to use the medication to contain further spread of the pandemic. The protocol recommended by the National Task force has been approved by the Drug Controller General of India for restricted use in emergency situations.

Side effects of hydroxychloroquine

According to MedlinePlus, the online information service produced by the United States National Library of Medicine, the side effects of hydroxychloroquine include headache, dizziness, loss of appetite, nausea, diarrhea, stomach pain, vomiting, and skin rash. Its overdose can lead to seizures or the patient falling unconscious.

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Due to higher in-vitro activity against SARS-CoV-2 and its wider availability in the United States compared with chloroquine, hydroxychloroquine has been administered to hospitalized COVID-19 patients on an uncontrolled basis in multiple countries, including in the United States. One small study suggested that hydroxychloroquine alone or in combination with azithromycin reduced detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit.
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Evaluating safety and efficacy of migraine preventive treatment for children, adolescents

Cephalalgia, the official journal of the International Headache Society, published the article entitled "Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial", by Man Amanat, and Mahmoud Reza Ashrafi from the Tehran University of Medical Sciences, Tehran, Iran.

Migraine affects about 8% of children and adolescents. About half of them continue to experience it into adulthood, leading to remarkable disability and a substantial social and financial burden to the patient and society. Early diagnosis and interventions can diminish the burden of the condition. 

Preventive pharmacologic treatment should be recommended when the frequency of headaches is more than 4 attacks per month or when the quality of life, school attendance or daily activities are restricted. Studies show that migraine preventive treatment can decrease the global burden of migraine. Although various preventive medications have been used for migraine in adults, few have been suggested in a pediatric population.

This paper studied the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in 149 children and adolescents (49 in the cinnarizine, 51 in the sodium valproate, and 49 in the placebo group).

Cinnarizine is a medicine that belongs to the category of antihistaminic medications. It is used to treat problems associated with the inner ear and the brain, dizziness, and sickness associated with motion sickness. Cinnarizine is used to relieve symptoms of motion sickness and balance (vestibular) disorders such as tinnitus (ringing in the ears), vertigo, nausea, and vomiting, as well as Ménières disease (a disorder of the inner ear).

Sodium valproate is a medication primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches. It is an anticonvulsant drug that is approved for use in epilepsy and bipolar disorder. It has also been used for neuropathic pain and migraine prophylaxis.

The medications were considered effective in reducing (more than 50%) the (frequency) number of migraine attacks and intensity, compared to the placebo group.

"Cinnarizine and sodium valproate may be useful for migraine preventive treatment for children and adolescents. Both medications are safe and well-tolerated in terms of adverse events, but cinnarizine could be considered as a new preventive option for pediatric migraine", explained the authors. Long term safety regarding weight gain should be studied in future trials.

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Roche launches Hemophilia A treatment drug in India

Drug firm Roche Wednesday said it has launched Emicizumab under the brand name Hemlibra in India for preventive treatment of Hemophilia A, an inherited disorder in which a person's blood does not clot properly.

Hemlibra is the first weekly subcutaneous prophylaxis injection shown to prevent or reduce the frequency of bleeding episodes and improve the quality of life, Roche said in a statement. 

All current prophylactic treatment options for people with Hemophilia A with factor VIII inhibitors require intravenous infusions several times a week, it added.


"The introduction of Emicizumab (Hemlibra) is a significant milestone in the treatment of Hemophilia A in India and reaffirms our commitment to bring Roche's ground breaking medicines to patients in India as early as possible," said a spokesperson of the company.

This breakthrough medicine represents a completely new way to manage Hemophilia A and redefines the standard of care, she added.

The company, however, did not disclose the price at which it would be selling the drug in the country.
Hemlibra is approved by multiple regulatory authorities across the world and is now also approved and available in India, the statement said.

Hemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to an uncontrolled and often spontaneous bleeding.

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