FDA安全性ステートメント :アクトスの膀胱癌との関連リスク


FDA Warns of Bladder Cancer Risk With Actos

FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
Safety Announcement [6-15-2011]

FDA recommends that healthcare professionals should:

Not use pioglitazone in patients with active bladder cancer.
Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.<

Counsel patients to report any signs or symptoms of blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer.

Encourage patients to read the Medication Guide they get with their pioglitazone medicine.

Report adverse events involving pioglitazone medicines to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.



」関連:フランス:アクトス投与控えるよう呼びかけ2011年 06月 10日

欧州2ヶ国でアクトス使用中止がなされた後、warningがなされた。European Medicines Agency (EMA)はアクトス使用のガイダンスを出した。市場規模の大きい米国、FDAの動きが注目されている。


by internalmedicine | 2011-06-16 08:11 | 糖尿病・肥満  

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