Japan’s PMDA Evaluates Side Effects of Insulins, Cancer Drugs

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Regulation | Keywords: #astrazeneca #cancer #elililly #insulin #janssen #novonordisk #pmda #sideeffects

PRICENTRIC BRIEF:

  • Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is currently investigating new side effect risks for 15 insulins and two cancer drugs
  • The PMDA is examining risks associated with Eli Lilly’s Humalog/Lyumjev (insulin lispro) and Novo Nordisk’s Xultophy (insulin degludec + liraglutide) and Fiasp (insulin aspart)
  • Also under review are two cancer medicines: AstraZeneca’s breast cancer drug Faslodex (fulvestrant) and Janssen’s prostate cancer drug Erleada (apalutamide)

THE DETAILS

TOKYO, Japan – Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is currently investigating new side effect risks for 15 insulins and two cancer drugs.

The PMDA is examining risks associated with Eli Lilly’s Humalog/Lyumjev (insulin lispro) and Novo Nordisk’s Xultophy (insulin degludec + liraglutide) and Fiasp (insulin aspart). For Novo’s insulins, the PMDA is assessing whether to add a precaution for the loss of control of blood sugar and hypoglycemia secondary to cutaneous amyloidosis or lipodystrophy.”

Also under review are two cancer medicines: AstraZeneca’s breast cancer drug Faslodex (fulvestrant) and Janssen’s prostate cancer drug Erleada (apalutamide).

Faslodex is being evaluated for injection site necrosis and ulceration and Erleada is being evaluated for the risk of toxic epidermal necrolysis.

 

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