The United States Food and Drug Administration (FDA) is cautioning health care providers regarding the newly revealed potential drug interaction linked to inspectional antiviral drug remdesivir that has given emergency utilization authorization for the treatment of the COVID-19 patients with serious disease.
Revision in the fact sheet
According to the recent non-clinical laboratory study, the Food and Drug Administration (FDA) correcting the fact sheet for health care providers, which follows drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not advised as it can lead to the decreased antiviral activity of remdesivir. The FDA is unaware of incidences of this decreased activity happening in the clinical trial; however, it is continuing to assess all data linked to remdesivir.
Additionally, the FDA amended the fact sheet for health care providers in order to explain administration guidance and dosing and to offer extra safety as well as supporting data from clinical trials performed by the National Institutes of Health as well as Gilead Sciences Inc., which is a drug sponsor. Apart from this, the fact sheet for patients and caregivers was too upgraded to add more information regarding probable allergic reactions and to inform patients and healthcare providers, whether they are consuming hydroxychloroquine sulfate or chloroquine phosphate.
Safety and efficiency of remdesivir
According to the M.D., acting director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, said, “During this uncommon COVID-19 crisis, the FDA has circulated emergency utilization authorizations for multiple medical products after assessing the existing scientific proof and critically adjusting any potential risks against the advantages of these products’ availability, especially during this pandemic.
Moreover, we know that with more product understanding, changes could be required depends on new data set like current updates for providers regarding a potential drug interaction and other essential information about the utilization of remdesivir in order to treat the COVID-19 patients.” Further, Cavazzoni, said, “the FDA keeps to assess all of the emergency use authorizations circulated and their linked materials and will keep doing changes as required depends on evolving data and science”
Following an assessment of the emergency use authorization criteria and the scientific evidence available, in May 2020 the FDA issued an emergency use authorization (EUA) allowing for remdesivir to be distributed in the United States and to be managed intravenously by health care providers. Additionally, the usage of remdesivir should be appropriate in order to treat suspected or confirmed COVID-19 patients as well as to treat pediatric patients hospitalized with the critical disease. The safety and efficiency of the remdesivir for the COVID-19 treatment continue to be assessed, and primary clinical trial outcomes have showcase that on average, remdesivir treatment on COVID-19 patients had more fast time to recovery.
Side effects of remdesivir
The EUA needs that fact sheets regarding the utilization of remdesivir in treating COVID-19 should be provided to patients, healthcare providers, and caregivers. This fact sheets contain information about desirable side effects like allergic reactions, increased levels of liver enzymes, shortness of breath, high heart rate, rash, nausea, vomiting, sweating, low blood pressure, difficulty swallowing, shivering, respiratory distress, angioedema, low heart rate, and wheezing.
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