FDA approves expanded use of Adacel for repeat Tdap vaccinations
An expanded use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine Adsorbed (Adacel) has been approved to include repeat vaccination to help protect against tetanus, diphtheria, and pertussis. The FDA's approval makes Adacel the first and only Tdap vaccine approved in the US for a repeat dose in individuals 10 to 64 years of age, 8 years or more after the first vaccination.
The approval for an expanded use of Adacel is based on clinical data from a study of the safety and effectiveness of repeat Adacel vaccination in adults that was carried out in over 1,300 patients, ages 18 to 64, who received either Adacel vaccine or a tetanus-diphtheria (Td) vaccine 8 to 12 years after a previous dose of Adacel vaccine. A second dose of Adacel in adults administered 8 to 12 years after a previous dose was found to produce no significant differences in adverse reactions between vaccine groups. At least one injection-site reaction was reported by 87.7% of Tdap recipients and 88.0% of Td vaccine recipients, according to the manufacturer, Sanofi-Pasteur.
Adacel is the only Tdap vaccine available in a syringe made without natural rubber latex, which may help reduce risk for patients with a latex allergy.
FDA approves prior approval supplement for factor Xa inhibitor reversal agent
The FDA approved Portola Pharmaceuticals' prior approval supplement application for its large-sale, second-generation coagulation factor Xa (recombinant), inactivated-zhzo, also known as andexanet alfa (Andexxa), allowing for a broad commercial launch in the US. Originally approved in May 2018 under the FDA's accelerated approval pathway, coagulation factor Xa (recombinant), inactivated-zhzo was designated both an orphan drug and a breakthrough therapy and is the first and only antidote indicated for patients treated with the factor Xa inhibitors rivaroxaban (Xarelto) or apixaban (Eliquis) when reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding.
There were approximately 140,000 hospital admissions attributable to factor Xa inhibitor-related bleeding in the US in 2017. Portola's statement says the approval allows the company to expand patient access to the drug, and it is now able to stock hospitals nationwide and serve all patients in the US who could benefit from the potentially life-saving impact of the drug. Consult product labeling for important precautions and prescribing information.
FDA issues a safety alert for higher doses of tofacitinib in patients with RA
The FDA is alerting the public that a clinical safety trial found an increased risk of pulmonary embolism (PE) and death when a 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). The FDA did not approve this 10-mg twice-daily dose for RA; it was approved only for the dosing regimen for patients with ulcerative colitis.
Pfizer, the manufacturer, is transitioning patients who were on the high 10-mg twice-daily dose to the lower 5 mg twice daily dose that was approved in the ongoing safety trial that was required by the FDA when it approved tofacitinib for RA. The trial is expected to be completed by the end of 2019.
The public and healthcare professionals will be updated with any new information based on the ongoing review. "Healthcare professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating," the FDA states. Patients should be monitored for signs and symptoms of PE and advised to seek medical attention immediately if they experience the symptoms of PE or other unusual symptoms, such as:
* sudden shortness of breath or difficulty breathing
* chest or back pain
* coughing up blood
* excessive sweating
* clammy or bluish-colored skin.