Sanofi has suspended recruiting participants for the clinical trials of using hydroxychloroquine to treat COVID-19. The French drugmaker is also suspending the distribution of the drug for coronavirus use on an off-label basis. The company stated it took this decision because of the safety concerns raised by the World Health Organization (WHO) who cited that there might be dangerous side-effects with using the drug for treating COVID-19.
“In line with WHO’s decision and out of caution, Sanofi has decided to temporarily suspend the recruitment of new patients in both of its clinical trials in COVID-19 patients, pending reassurance on the safety profile of HCQ,” a company spokesperson said. “Patient safety is Sanofi’s primary focus.”
A derivative of chloroquine, hydroxychloroquine is usually prescribed for patients with lupus and rheumatic arthritis. WHO said the clinical trial of hydroxychloroquine must be pegged pending the review of safety data by its Data Safety Monitoring Board. The world health body obviously made the move in response to a study published by The Lancet stating that almost all hospitalized COVID-19 patients treated with hydroxychloroquine died.
The journal also found that coronavirus patients treated with hydroxychloroquine developed irregular heart rhythms in research that examined 96,000 patients across 671 hospitals in six continents across the globe. Even rheumatoid arthritis and lupus patients who take the drug as a prescription report experiencing heart arrhythmia and muscle weakness.
Although hydroxychloroquine is not expressly recommended for the treatment of COVID-19, doctors are allowed to administer it to patients as an off-label drug. An off-label drug is a medication that is approved by the Food and Drug Administration for use on an illness for which it is not manufactured. The FDA also approved the drug for coronavirus only within a hospital and under the strict supervision of medical doctors and also within very controlled situations.
President Donald Trump announced he is taking the drug to prevent contracting COVID-19 even though his medical advisers and health agencies advise against it. In fact, a White House physician, Dr. Sean Conley, stated in support of the president that “the potential benefit from treatment outweighed the relative risks” associated with the drug.
An article published in the journal Science News and titled “Politics aside, hydroxychloroquine could (maybe) help fight COVID-19” suggests that there is no harm in using the drug for coronavirus even though it has serious side-effects in people with existing heart conditions. Written by Tina Hesman Saey, a geneticist with a doctorate in molecular genetics but now a journalist, the article stated that there is “not enough data to say whether the drug can protect people from catching COVID-19 or from getting very ill if they do get infected with the virus.”