Whitehouse Centers for Disease Control and Prevention US Department of Homeland Security - Federal Emergency Management Agency

Medications

Currently, there are no Food and Drug Administration (FDA) approved drugs specifically for the treatment of COVID-19. Researchers are studying new drugs, and drugs that are already approved for other health conditions, as possible treatments for COVID-19. The Centers for Disease Control and Prevention has more information for health care providers about these potential treatments.

The FDA is protecting consumers from unapproved products and false or misleading claims. Consumers and health care professionals can help by reporting suspected fraud to the FDA’s Health Fraud Program or the Office of Criminal Investigations.

Last updated April 06, 2020 | Source: FEMAlinks to external site

Currently, there is no evidence to support transmission of COVID-19 associated with imported goods, including food and drugs for humans and pets. There have not been any cases of COVID-19 in the United States associated with imported goods.

Last updated April 15, 2020 | Source: FDAlinks to external site

No. Antibiotics do not work against viruses; they only work on bacterial infections. Antibiotics do not prevent or treat coronavirus disease (COVID-19), because COVID-19 is caused by a virus, not bacteria. Some patients with COVID-19 may also develop a bacterial infection, such as pneumonia. In that case, a health care professional may treat the bacterial infection with an antibiotic.

Last updated April 15, 2020 | Source: FDAlinks to external site

No. Hydroxychloroquine sulfate and some versions of chloroquine phosphate are FDA-approved to treat malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis. Read more about the emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate for COVID-19.

Last updated April 15, 2020 | Source: FDAlinks to external site

At this time, there are no FDA-approved drug products to treat COVID-19. The FDA is working with drug manufacturers and investigational new drug sponsors to expedite the development and availability of COVID-19 treatments. Read more about FDA’s actions to address the novel coronavirus with medical countermeasures.

Researchers are studying new drugs and drugs that are already approved for other health conditions as possible treatments for COVID-19. CDC has more information for health care providers about these potential treatments.

Last updated April 15, 2020 | Source: FDAlinks to external site

In the lab, these drugs have been shown to prevent the growth of the virus that causes COVID-19. There are a few reports of patients with COVID-19 who received these drugs and improved. Some are reports of groups of patients, all of whom received the drug. It is not known whether it was the drug that led to the improvement or whether there were other factors involved. We do not know if the treated patients’ condition would have improved without the drug. To know this, there would have to be a group of similar patients who did not receive the drug (control).

Because chloroquine phosphate and hydroxychloroquine may possibly help very sick patients, FDA is allowing these drugs to be provided to certain hospitalized patients under an Emergency Use Authorization (EUA) issued March 28, 2020. Under the EUA, health care providers and patients are provided with information about the risks of these drugs. However, more data from clinical trials are necessary for us to determine whether chloroquine phosphate or hydroxychloroquine sulfate are safe and effective in treating or preventing COVID-19.

Last updated April 15, 2020 | Source: FDAlinks to external site

The FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.

We have been reaching out to manufacturers as part of our approach to identifying potential disruptions or shortages. We will use all available tools to react swiftly and mitigate the impact to U.S. patients and health care professionals when a potential disruption or shortage is identified.

Find real-time information about drug shortages.

Learn more in our drug shortages frequently asked questions.

Last updated April 15, 2020 | Source: FDAlinks to external site

No. Products marketed for veterinary use, “for research only,” or otherwise not for human consumption have not been evaluated for safety or effectiveness and should never be used by humans. FDA is aware that chloroquine phosphate is marketed to treat disease in aquarium fish, but these products have not been evaluated by FDA to determine if they are safe, effective, properly manufactured, and adequately labeled. The agency continues to work with online marketplaces to remove these items, and many have been removed based on these efforts. Patients should not take any form of chloroquine unless it has been prescribed by a licensed health care provider. Chloroquine products also should not be given to pets or livestock unless prescribed by a veterinarian.

Last updated April 15, 2020 | Source: FDAlinks to external site

No. While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.

A recently released research article described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19. Read more about ivermectin.

Last updated April 15, 2020 | Source: FDAlinks to external site

We have established a cross-agency task force dedicated to closely monitoring for fraudulent COVID-19 products. We have reached out to major retailers to ask for their help in monitoring online marketplaces for fraudulent COVID-19 products. Products sold are subject to FDA investigation and potential enforcement action if they claim to prevent, diagnose, treat, or cure COVID-19 and have not demonstrated safety and effectiveness for that intended use. The task force has already worked with retailers to remove dozens of these types of product listings online.

The FDA and the Federal Trade Commission (FTC) issue warning letters to companies that violate federal law and pose significant risks to patient health by selling unapproved products with fraudulent claims to treat or prevent COVID-19. View the warning letters for more information.

Last updated April 15, 2020 | Source: FDAlinks to external site

No. Miracle Mineral Solution does not cure COVID-19 and has not been approved by the FDA for any use. The solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects. For more information, see: FDA warns consumers about the dangerous and potentially life threatening side effects of Miracle Mineral Solution and Danger: Don’t Drink Miracle Mineral Solution or Similar Products.

Last updated April 15, 2020 | Source: FDAlinks to external site

As mentioned above, chloroquine phosphate is only approved for the treatment of malaria, and hydroxychloroquine sulfate is only approved for the treatment of malaria, lupus, and rheumatoid arthritis. Once FDA has approved a drug, healthcare providers generally may prescribe or administer the drug for an unapproved use, including in clinical settings not described in the approved labeling. This decision will be based on their assessment of the potential benefits versus the risks for their patient, recognizing that FDA has not assessed the safety or effectiveness of such use.

Last updated April 20, 2020 | Source: FDAlinks to external site

Preliminary data from a Phase 3 study conducted by the USG demonstrated that hospitalized patients with COVID-19 who received remdesivir recovered faster than similar patients who received a placebo. A different Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in hospitalized patients with severe COVID-19 (most patients were not receiving mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at baseline), found that a 5-day treatment course had a similar treatment effect as a 10-day treatment course. The safety and efficacy of remdesivir for treatment of COVID-19 is currently being evaluated in multiple clinical trials.

In vitro (laboratory) testing of remdesivir also shows it is active against SARS-CoV-2, the virus that causes COVID-19.

Because remdesivir may help hospitalized patients with severe COVID-19, FDA authorized its use under an Emergency Use Authorization (EUA) issued on May 1, 2020. Under the EUA, health care providers and patients are provided with information about the risks of remdesivir. However, additional evidence from clinical trials are necessary to determine whether the drug is safe and effective in treating or preventing COVID-19.

Last updated May 06, 2020 | Source: FDAlinks to external site