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FDA Warns of Possible Bladder Cancer Risk from Pioglitazone


FDA Warns of Possible Bladder Cancer Risk from Pioglitazone

The label for the diabetes drug pioglitazone (Actos) will now warn patients about a potential increased risk for bladder cancer when taken for 1 year or more, the FDA announced on Wednesday. Last week, France decided to pull pioglitazone off the shelves over similar concerns, and Germany recommends that new patients not start using the drug.

The FDA says it based its decision on 5-year interim data showing an increased risk for bladder cancer among those who took pioglitazone the longest and at the highest doses.

The agency is warning clinicians not to use the drug in patients with active bladder cancer and says they should use it cautiously in patients with prior bladder cancer.

In its announcement, the French drug agency AFSSAPS said that a French cohort of some 155,000 patients with diabetes who were exposed to pioglitazone, when compared with a nonexposed diabetic cohort, showed a statistically significant association between exposure to the drug and the incidence of bladder cancer.

In September 2010 the FDA said it was following a 10-year epidemiological study of the association. Interim results showed an increased risk among patients with the longest exposures and the highest cumulative doses of Actos.

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the best's picture
by
طالب دراسات عليا

intersting and important... thanx
Fouad's picture
Fouad
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Quote:
شكراً

قرأت الخبر من حوالي يومين وكنت أريد وضعه على حكيم ولكن لم يسمح لي الوقت

الدواء يوجد في السوق السورية باسم أكتازون (شركة آسيا)

أعرف شخصاً يأخذه من حوالي العشر سنين وقد أصيب بسرطان المثانة

there's an association but causality hasn't been proved yet
if the person you know is a smoker, it's probably the cause rather than the pioglitazone

Nostradamus

Quote:
intersting and important... thanx
S.AMH's picture
S.AMH
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ابق على تواصل مع حكيم!
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