Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
November 1, 2023
The Food and Drug Administration (FDA) released a bulletin today through their MedWatch listserv to provide information about the correct
dosage and administration of Moderna COVID-19 vaccine (2023-2024 Formula) for individuals 6 months through 11 years of age.
FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
May 11, 2023
The U.S. Food and Drug Administration (FDA) released a drug safety communication to address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants. The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. Updated Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class and advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.
DEA Reports Widespread Threat of Fentanyl Mixed with Xylazine
March 22, 2023
The Drug Enforcement Agency (DEA) issued a Public Safety Alert to warn the American public of a sharp increase in the trafficking of
fentanyl mixed with xylazine. Xylazine, also known as "Tranq," is a powerful sedative that the U.S. Food and Drug Administration has
approved for veterinary use. The DEA has seized xylazine and fentanyl mixtures in 48 of 50 States. The DEA Laboratory System is
reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.
Increase in Pediatric Invasive Group A Streptococcal Infections
December 22, 2022
The Centers for Disease Control and Prevention (CDC) issued a Health Advisory to notify clinicians and public health authorities of a recent increase in pediatric invasive group A streptococcal (iGAS) infections.
Risk of severe hypocalcemia in patients on dialysis receiving denosumab
November 22, 2022
FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced
kidney disease on dialysis treated with the osteoporosis medicine denosumab (Prolia®).
Possible increased risk of death, serious side effects with duvelisib (Copiktra)
June 30, 2022
The FDA warns of a possible increased risk of death with the cancer drug, duvelisib (Copiktra) used in the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
COVID-19 Rebound After Paxlovid Treatment
May 25, 2022
The Centers for Disease Control and Prevention (CDC) released a Health Advisory Network (HAN) Health Advisory on the potential for
recurrence of COVID-19 or "COVID-19 rebound."
FDA: Monitor Babies & Young Children Who Receive Injections of Iodine-Containing Contrast Media
March 30, 2022
The FDA recommends that newborns and children through 3 years old have thyroid monitoring within 3 weeks post-injection of iodinated contrast media for medical imaging procedures.
Dental Problems Have Been Reported with Medicines Containing Buprenorphine that are Dissolved in the Mouth
January 12, 2022
The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.