Your source for the latest industry trends and drug information news.
Volume 5 | Issue 4
March 1, 2023
Contributors:
Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate
On February 1, 2023, the U.S. Food and Drug Administration (FDA) announced its approval of Jesduvroq®(daprodustat) tablets for use in dialysis patients to treat anemia caused by chronic kidney disease (CKD). Anemia is a condition in which a patient does not have enough healthy red blood cells, reducing the ability of the blood to transport oxygen to important organs and body tissues. Patients with kidney disease can develop anemia because the kidneys produce an important hormone, erythropoietin, that signals the body to produce red blood cells. Without sufficient erythropoietin levels, production of red blood cells is reduced. Injectable erythropoietin medications are available and have served as the standard of care for this type of anemia. Now with the approval of Jesduvroq, patients have the option of an oral alternative to manage this condition. Jesduvroq stimulates the body’s ability to make its own erythropoietin so it can maintain red cell production. Jesduvroq was tested in a study of nearly 3,000 patients with chronic kidney disease receiving dialysis. Participants in this study received either oral Jesduvroq or an injection of recombinant human erythropoietin, and both groups had very similar results. This study showed that oral Jesduvroq was as effective as injectable erythropoietin in treating anemia caused by CKD. Patients treated with Jesduvroq should be monitored for blood clots as the medication increases this risk. Other possible side effects include an increase in blood pressure, abdominal pain, dizziness and allergic reactions.
On February 20, 2023, the FDA released a company announcement for a recall on two select batches of Enfamil ProSobee Simply Plant-Based Infant Formula due to potential Cronobacter sakazakii contamination. This recall is specifically for 12.9 oz containers. The manufacturer states no other ProSobee Simply Plant-Based formula batches or other Reckitt products are impacted. The recalled products have batch codes of ZL2HZF or ZL2HZZ, both of which have a UPC Code of 300871214415 and a “Use By Date” of “1 Mar 2024”. Consumers who purchased this product may contact the company at 1-800-479-0551 or email consumer.relations@rb.com to verify if their purchased product was impacted. The FDA recommends disposing of or returning this product to the place of purchase for a total refund. To date, there have been no illnesses reported in connection with this recall. The Centers for Disease Control and Prevention (CDC) states infants who are infected with the bacteria may have initial symptoms such as fever, poor feeding, excessive crying and very low energy. Parents noticing these symptoms should seek out medical help right away. However, the product has been extensively tested with negative results for bacterial contaminants, and the risk of infection is considered unlikely.
On February 6, 2023, the CDC published a study regarding the benefits to newborns when mothers receive the Tdap vaccination in their third trimester of pregnancy. The Tdap vaccination protects against the pathogens that cause tetanus, diphtheria, and pertussis (also known as whooping cough). Whooping cough is extremely contagious and can be very serious, even fatal, in infants who are too young to be vaccinated. Their risk can be increased if those in close contact with them are not up to date with their Tdap vaccine. The findings of this 20-year study support the CDC’s recommendation for getting the Tdap vaccine between weeks 27-36 of pregnancy by showing it offers protection from whooping cough during an infant’s first two months of life. The Tdap vaccination is safe and effective in pregnancy and protects 90% of newborns from hospitalization due to whooping cough. In October 2022, the FDA officially approved the Boostrix (Tdap) vaccine for immunization during the third trimester of pregnancy. It is recommended that women be vaccinated during the third trimester of each pregnancy to boost their production of important antibodies against whooping cough and to pass these protective antibodies to their infants before birth.
New Dosage Form: Atorvaliq® (atorvastatin)
Oral suspension approved to treat high cholesterol levels in adults and children and to reduce the risk of serious cardiac events in high-risk patients. [2/1/2023 - CMP PHARMA INC]
Cambia® (diclofenac potassium)
Indication: Treatment of migrIndication
Dosage Form/Strength: 50mg powder packets for oral solution
Average Wholesale Price (AWP): Generic = $958 | Brand = $1,064
