FDA Issues Update on Antimalarial Drugs Used to Treat COVID-19, Reminds Health Care Providers to Closely Monitor Patients to Mitigate Risks
Food and Drug Administration (FDA) has issued a drug safety communication regarding the known side effects of hydroxychloroquine and chloroquine that have been reported with their use for the treatment or prevention of coronavirus disease 2019 (COVID-19). FDA has reviewed – and continues to investigate – case reports in the FDA Adverse Event Reporting System database, published medical literature, and the American Association of Poison Control Centers’ National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with the antibiotic azithromycin or other medicines. As indicated in the emergency use authorization (EUA), the risks associated with these medications can be mitigated when health care providers closely screen and supervise these patients, such as in a hospital setting or a clinical trial.
“We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” said FDA Commissioner Stephen M. Hahn, MD, in a press release. “While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered. We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks.”
CDC Recognizes Six Additional COVID-19 Symptoms
Centers for Disease Control and Prevention (CDC) has added six new symptoms to the existing list of symptoms for COVID-19. In addition to dry cough, fever, and shortness of breath, the newly recognized symptoms include chills, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell. According to CDC, patients who show at least two of the new symptoms may have COVID-19, and therefore meet the agency’s testing guidelines. Symptoms typically appear within two to 14 days after exposure to the virus.
Other developments over the last few days include:
- FDA warned consumers about hand sanitizers with fraudulent claims.
- FDA updated and re-issued the EUA for face masks posted on April 18, 2020, to clarify face masks, including cloth face coverings, that are authorized by the EUA are only authorized for use by the general public and health care personnel as source control.
- New research indicated that COVID-19 may be causing strokes and heart attacks in some patients who are not normally at risk for those conditions.
- CDC has confirmed COVID-19 in two pet cats in New York state.
Daily updates on the spread of the virus, including a state-by-state breakdown of known infections and fatalities, are available from CDC. International information is available from the World Health Organization.
NABP continues to collect information about how boards of pharmacy are responding to COVID-19 in the Coronavirus Updates section of the NABP website. Pharmacists are also encouraged to check their state board(s) of pharmacy websites for jurisdiction-specific information. Additional resources for pharmacists and other health care providers are available from the American Pharmacists Association’s Pharmacists’ Guide to Coronavirus.
FDA Issues Warnings to Two Companies Selling CBD Products for Treating Medical Conditions
FDA has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD), which were marketed to treat medical conditions, including opioid addiction. This action is the latest of the agency’s efforts to pursue companies that illegally market CBD products with unproven claims. In March 2020, FDA provided updates on its work related to CBD products with a focus on protecting public health and providing market clarity. FDA continues to be concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by FDA and determined to be safe, or that using CBD “can’t hurt.” FDA remains focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.
“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a press release. “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”
FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.
More information about this issue can be found in the February 2020 issue of Innovations® and on the FDA website.
Investigation into Fentanyl Trafficking Ring Leads to Six Arrests
Six men have been arrested in Connecticut for their alleged role in illegally distributing fentanyl and related money laundering charges. The arrests were made after an investigation revealed that the organization was distributing fentanyl and other narcotics to other drug traffickers, who were in turn distributing to street vendors.
During the investigation, one member of the trafficking ring, David Cintron, was arrested with nearly 5,000 wax paper sleeves of fentanyl, 90 grams of unpackaged fentanyl, and other items used to process and package narcotics. Between August and October 2019, investigators seized more than $200,000 in cash from members of the drug trafficking ring. During the arrests on April 28, 2020, an additional $100,000 in cash was seized, along with a firearm, and several thousand wax folds of suspected fentanyl.
“Fentanyl is causing great damage to our communities,” said Drug Enforcement Administration (DEA) Special Agent in Charge Brian D. Boyle in a press release. “The men and women of DEA along with our law enforcement partners are hard at work protecting the public by taking this poison off the streets of Connecticut, especially during this very uncertain time of COVID-19.”