Actos Cancer Risk Results in French Recall for Diabetes Drug
French health authorities have suspended Actos sales, following data that provides further evidence that users of the diabetes drug may face an increased risk of bladder cancer.
The Actos recall was announced on Thursday by AFSSAPS, the medical regulatory agency of France.
French authorities also pulled a drug known as Competact, a combination of Actos and metaformin, from the market as well. Both are manufactured by Takeda Pharmaceuticals.
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The French decision to remove Actos from the market came after a review of French public insurance data found a slight increase in the risk of bladder cancer from Actos. In France, the drug is taken by about 230,000 people.
AFSSAPS said that patients should not stop taking the drug without consulting their physician, but told doctors they should no longer prescribe it.
An Actos cancer risk has been suggested in a number of recent studies.
In September 2010, the FDA announced that it was investigating the potential link between bladder cancer and Actos after data from an ongoing 10-year study by Takeda Pharmaceitucals suggested that users may have an increased risk of cancer from Actos the longer they took the medication. However, to date, the FDA has not concluded that there is an increased risk of cancer from Actos.
Last month, a study by Italian researchers found a disproportionate number of Actos bladder cancer reports in the FDA’s own Adverse Event Reporting System Records. However, that study did not establish a causal effect between Actos and bladder cancer.
Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.
Sales have increased in recent years after a number of studies have suggested that Actos may be safer than its competitor, Avandia, which has been linked to an increased risk of heart attacks and deaths.
A number of former users who have been diagnosed with bladder cancer have contacted lawyers in recent months to determine whether they may be entitled to compensation through an Actos lawsuit as a result of the manufacturers failure to adequately warn about the potential side effects.
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