FDA Revokes Emergency Use Authorization:
On June 15, 2020, the Food and Drug Administration (FDA) rescinded the Emergency Use Authorization (EUA) allowing hospital patients to use certain malaria medications such as hydroxychloroquine and chloroquine for treating COVID-19. The announcement warned that these medicines “are unlikely to be effective in treating COVID-19 for the authorized users in the EUA” and that “the totality of scientific evidence currently available indicates a lack of benefit.”
Furthermore, the announcement also cited a non-clinical study that administered the two drugs along with Gilead’s remdesivir COVID-19 medication and the presence of the malaria drugs “may result in the reduced antiviral activity of remdesivir.”
Why Did the FDA Revoke the Emergency Use Authorization?
The FDA stated in their announcement: “In light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits” of hydroxychloroquine no longer outweigh those risks.”
The June 15 announcement comes less than 2 months after the FDA warned patients and caregivers that hydroxychloroquine and chloroquine have been linked to life-threatening heart rhythm problems. The FDA reiterated this warning in the June 15 announcement, stating that hydroxychloroquine and chloroquine have been connected to “ongoing serious cardiac adverse events and other potential serious side effects.”
The EUA was first issued in March 2020 and applied to patients who were hospitalized with COVID-19 and those in clinical trials. However, in April the FDA warned doctors against prescribing the drug to COVID-19 patients outside of hospitalization and clinical trial conditions.
Since the FDA granted the EUA, researchers have reported that patients treated with the medications have died at a higher rate than those receiving regular treatment for COVID-19.
In April 2020, the FDA issued a warning telling patients and caregivers that malaria drugs (such as hydroxychloroquine and chloroquine) have been reported to have serious and life-threatening side effects when used to treat the disease. The announcement also included the warning that patients with other health issues, such as heart and kidney disease, are likely to be at an increased risk of heart problems when taking hydroxychloroquine and chloroquine.
Just prior to the June 15 announcement, research from the University of Minnesota Medical School published in the New England Journal of Medicine found that hydroxychloroquine was no more effective than a placebo at preventing COVID-19 symptoms among people exposed to coronavirus.
This is the first major clinical trial analyzing whether the medication might be useful as a prophylactic. The study focused on 821 people who had been in close contact with a confirmed COVID-19 patient—putting those 821 people at an increased risk of developing COVID-19 themselves.
Study participants were sent doses of either hydroxychloroquine or a placebo and asked to take the pills for two weeks. The study was double-blind—neither the study participants nor the researchers knew in advance which people would be getting the real medication.
At the end of the two weeks, there was virtually no difference in who developed COVID-19 symptoms. 12% of those given hydroxychloroquine reported symptoms, compared with 14% of those who were given a placebo.
What is Hydroxychloroquine and What Does It Do?
Hydroxychloroquine is a drug traditionally used to treat malaria and certain autoimmune conditions, such as lupus and rheumatoid arthritis. However, the FDA’s June 15 announcements do not apply to the drug’s treatment of these conditions.
Hydroxychloroquine first gained attention as a potential COVID-19 treatment in February 2020 when two small studies suggested that it might be useful against the COVID-19 virus.
President Donald Trump encouraged its use, even saying in May 2020 that he took hydroxychloroquine to prevent COVID-19.
How Do I Know If I Have Been Harmed?
Common Side Effects Include:
- Stomach cramps
Serious Side Effects:
- Blurred vision or other vision changes (may be permanent in some cases)
- Heart disease, heart failure, issues with heart rhythm (some cases have been fatal)
- Ringing in your ears or hearing loss
- Angioedema (rapid skin swelling)
- Mild or severe bronchospasm (tightening of muscles that line the lungs’ airways)
- Persistent sore throat
- Hypoglycemia (low blood sugar)
- Unusual bleeding or bruising
- Blue-black skin color
- Muscle weakness
- Hair loss or changes in hair color
- Abnormal mood changes
- Mental health effects, including suicidal thoughts
- Shortness of breath
- Swelling of ankles/feet
- Unusual tiredness
- Unusual/sudden weight gain
- Symptoms of Hypoglycemia (low blood sugar)
Symptoms of Hypoglycemia (low blood sugar)
- Sudden sweating or shaking
- Blurred vision
- Tingling hands or feet
How GoldenbergLaw Can Help You
The attorneys at GoldenbergLaw have handled dangerous drug cases for more than 30 years and will provide you with the Gold standard of advocacy that you deserve.