FDA Warning on Actos & Pioglitazone
The US Food and Drug Administration’s Safety Announcement Links Actos to Bladder Cancer
On June 6, 2011, the US Food and Drug Administration issued a safety announcement regarding the diabetes medication, Actos. This was following a planned five-year interim analysis of a current ten-year study on Pioglitazone.
The results of the five-year study concluded that while there was no increased risk of bladder cancer associated with immediate use of the drug, there was an increased risk of bladder cancer found among those with an exposure to Actos over a longer period of time. In addition, those exposed to the highest cumulative dose of pioglitazone showed a marked increased risk as well.
Based on this conclusion, the FDA recommended to doctors and other healthcare professionals:
- Do not prescribe Actos to patients with bladder cancer.
- Take caution in giving Actos to patients with a prior history of bladder cancer, and note the balancing of interests between control of blood sugar and unknown risks of a recurrence of cancer.
The FDA further advises that these risks be placed on the Warnings and Precautions section of the label for Actos.
Furthermore, the FDA is aware that there are joint studies being conducted in both France and Germany. Each of these studies produced the same increased risk of bladder cancer from prolonged use as Actos. France has suspended use of the drug because of the country’s own studies, and Germany is recommending that doctors not begin Actos treatment with new patients.
To summarize, the FDA advises patients of an increased risk of bladder cancer with those who have been exposed to Actos over a greater period of time. Also, those with bladder cancer or a history of bladder cancer should discontinue use under the care of their physician.
Our Law Firm Can Help
If, following the use of the drug Actos, you have suffered from bladder cancer or another serious injury, our Dallas Actos drug injury attorneys of Grossman Law Offices may be able to help you recover damages. We offer free consultations, so call us today to ask questions and to discuss your situation with our Dallas Actos injury lawsuit attorneys. We can be reached 24 hours a day, seven days a week. Call Grossman Law Offices at 1-855-326-0000 (toll free).
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