PMDA recommends package insert revisions for five products
- PDF / 170,181 Bytes
- 1 Pages / 595.245 x 841.846 pts (A4) Page_size
- 104 Downloads / 141 Views
1
PMDA recommends package insert revisions for five products Precautions should be revised in the package inserts for selected vonoprazan-containing products, cytarabine and piperacillin/tazobactam, says Japan’s PMDA. Vonoprazan is used for the treatment of peptic ulcers. The regulatory agency has indicated that shock, anaphylaxis and hepatic impairment should be added to the "Clinically Significant Adverse Reactions" section for vonoprazan fumarate, and two other vonoprazan fumarate-based triple therapy regimens (vonoprazan fumarate/ amoxicillin hydrate/clarithromycin and vonoprazan fumarate/amoxicillin hydrate/metronidazole). The antimetabolic agent cytarabine should also have "cytarabine syndrome" added to the "Clinically Significant Adverse Reactions" section for this product. The PMDA said that "cytarabine syndrome may occur as pyrexia, muscle pain, bone pain and occasionally as rash maculo-popular, chest pain, conjunctivitis, and malaise". In addition, the PMDA is recommending that the "Important Precautions" section be updated to note that "eye symptom" (including conjunctivitis, eye pain, photophobia, eye discharge, conjunctival hyperaemia, and corneal ulcer) and "cutaneous symptom" (including rash, redness, and erythema in the distal portion of the extremities) are known characteristic adverse reactions to this drug. Corticosteroids may be used to reduce (or prevent) these symptoms. Finally, the PMDA recommended that the antibacterial preparation piperacillin/tazobactam package insert should be revised to include hypokalaemia in the "Clinically Significant Adverse Reactions" section. The agency noted that "hypokalaemia accompanied by malaise, feelings of weakness, arrhythmia, or convulsion may occur", and that patients should be monitored carefully. If they experience any abnormalities, then treatment with piperacillin/tazobactam should be discontinued and appropriate measures taken. Pharmaceuticals and Medical Devices Agency of Japan. Revisions of PRECAUTIONS (FY2020): Preparations containing vonoprazan fumarate (excluding aspirin/vonoprazan fumarate combination tablets); cytarabine (excluding 400 mg and 1 g preparations); tazobactam/piperacillin hydrate. Internet Document : 6 Oct 2020. Available from: URL: 803508903 https://www.pmda.go.jp/english/safety/info-services/drugs/revision-of-precautions/0008.html
0114-9954/20/1826-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
Reactions 17 Oct 2020 No. 1826
Data Loading...
