Details on recently authorized COVID-19 vaccine

Recalls and warnings

A warning that results from a clinical trial show a possible increased risk of death with duvelisib (Copiktra) compared to another medication to treat leukemia and lymphoma. The trial also found that the drug was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels. The FDA continues to evaluate the drug's safety and plans to hold a public meeting and decide whether it should continue to be prescribed.

A class I recall of certain Medfusion 3500 and 4000 Syringe Infusion Pumps by Smiths Medical due to eight software malfunctions that may impact infusion delivery. Seven related serious injuries and one related death have been reported. The recall includes 118,055 devices distributed from October 2004 to Feb. 17, 2022.

A class I recall of Carescape R860 ventilator backup batteries by GE Healthcare because their early failure may cause unexpected ventilator shutdown. There have been 1,553 complaints and one injury associated with this issue. The recall includes 4,222 backup batteries, including replacement backup batteries, distributed from April 2, 2019, to April 18, 2022.

A class I recall of all V60 and V60 Plus Ventilators by Philips Respironics because an internal power fluctuation may cause them to shut down unintentionally, with or without visible or audible alarms. There have been four injuries and one death associated. The recall includes 56,671 devices distributed from May 1, 2009, to Dec. 22, 2021.

A class I recall of the Volara system by Baxter Healthcare Corporation due to risk of respiratory distress in ventilated patients during home use. The in-line ventilator adaptor may prevent patients from getting enough oxygen from their ventilators. There have been two deaths and one injury associated. The recall includes 268 devices distributed from May 28, 2020, to April 19, 2022.

A class I recall of SafeStar 55 Breathing System Filters by Draeger due to possible obstructions that may block oxygen flow to patients. There has been one injury associated. The recall includes 35,950 devices distributed from Aug. 18 to Oct. 12, 2021.

A class I recall of Abacus Order Entry and Calculation Software by Baxter Healthcare Corporation due to a risk of medication label errors. The recall includes three versions of software with three configurations distributed from May 20, 2013, to Sept. 20, 2019, affecting 1,114 customers.

A recall of one lot of HeartWare Ventricular Assist Device System batteries by Medtronic due to potential malfunction. There have been two complaints and one death related to this issue. The recall includes 429 products distributed from April 20 to July 19, 2021.

A recall of several lots of laxatives and antacids by Plastikon Healthcare LLC due to microbial contamination. The recall includes one lot of milk of magnesia oral suspension, 11 lots of magnesium hydroxide/aluminum hydroxide/simethicone oral suspension, and two lots of magnesium hydroxide/aluminum hydroxide/simethicone oral suspension. No related adverse events have been reported. Recalled products were distributed to a wholesaler between July 1, 2020, and Oct. 31, 2021, and were further distributed to hospitals, nursing homes, and clinics nationwide.

A recall of one lot of 30-mg and one lot of 60-mg morphine sulfate extended-release tablets by Bryant Ranch Prepack Inc. due to a label mix-up. Bottles labeled as containing 60-mg tablets may contain 30-mg tablets and vice versa.

A recall of all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution by Vi-Jon LLC due to microbial contamination. To date, the company has received three reports of serious adverse reactions potentially related to this recall. Recalled products were distributed nationwide to wholesale and retail outlets.

Miscellaneous

An update on the FDA's response to the monkeypox outbreak in the U.S. The agency has been working with federal public health partners to track reports of monkeypox transmissions and is coordinating preparedness efforts. An FDA-approved vaccine for the prevention of monkeypox disease in adults and an FDA-cleared diagnostic test are already in place, and the antiviral medication tecovirimat (TPOXX) is being made available for the treatment of monkeypox disease through the CDC under expanded access or “compassionate use.” The FDA plans to make additional diagnostics and treatments available. When testing for the monkeypox virus, use samples taken directly from a lesion to avoid false results, the agency advised.

COVID-19 updates

An emergency use authorization (EUA) for the Novavax COVID-19 Vaccine to prevent COVID-19 in adults. In an ongoing, randomized controlled trial conducted in the U.S. and Mexico prior to the emergence of delta and omicron variants, the vaccine was 90.4% effective overall in preventing mild, moderate, or severe COVID-19. In the subset of participants ages 65 years and older, the vaccine was 78.6% effective. The most reported side effects were pain/tenderness, redness, and swelling at the injection site; fatigue; muscle pain; headache; joint pain; nausea/vomiting; and fever. As a condition of authorization, the manufacturer will conduct studies to further assess the safety of the vaccine, including those assessing the risks of myocarditis and pericarditis. The vaccine is administered as a two-dose primary series, three weeks apart. It contains the SARS-CoV-2 spike protein, produced in insect cells, and Matrix-M adjuvant, which contains saponin extracts from the bark of the soapbark tree that is native to Chile.

A revised EUA for nirmatrelvir and ritonavir (Paxlovid) authorizing state-licensed pharmacists to prescribe the antiviral to eligible patients who have tested positive for COVID-19, with certain limitations. ACP has expressed concern about this policy.

Approvals

A new indication for baricitinib (Olumiant) oral tablets to treat adult patients with severe alopecia areata. The Janus kinase inhibitor is the first FDA-approved systemic treatment for this condition. The drug has a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. It was originally approved in 2018 for certain adult patients with moderately to severely active rheumatoid arthritis and is also approved for treating COVID-19 in certain hospitalized adults.

First-time generic approvals

Estradiol and progesterone capsules (1 mg/100 mg) for the treatment of moderate to severe vasomotor symptoms due to menopause. (Brand name: Bijuva)

Diclofenac topical solution (2% w/w) for the treatment of the pain of knee osteoarthritis. (Brand name: Pennsaid)

Mesalamine extended-release capsules USP (500 mg) for induction of remission in and for treatment of adults with mildly to moderately active ulcerative colitis. (Brand name: Pentasa)

Posaconazole injection (300 mg/16.7 mL [18 mg/mL] in single-dose vials) for the prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients (Brand name: Noxafil)

Note: The FDA states that drugs are not always commercially available immediately after approval.