FDA, EMA Want New Warnings for Actos Bladder Cancer

Washington, DCWhile the risk remains small, the European Medicines Agency (EMA) nonetheless has gone on record as saying, in its view, that the risk for Actos bladder cancer warrants an updated warning. Industry watchers will now be waiting to see if other European countries fall into line now that the EMA has released its official position on Actos following a safety review.

In June, France and Germany pulled both Actos and an Actos hybrid known as Competact (Actos combined with metformin) from the market, whereas other countries in the European union appeared to be waiting for the EMA's position.

Actos side effects were the least of patient's worries in recent years after Avandia, manufactured by GlaxoSmithKline, was identified as having a higher risk for cardiac and heart issues than its Type 2 Diabetes competitor, Actos. To that end, the Takeda product is thought by many doctors to be safer than Avandia due to a lower risk for Actos heart failure. Actos, manufactured by Takeda Pharmaceuticals, has since benefitted from Avandia's decline. According to Reuters Health, on July 21, Actos accounted for 27 percent of Takeda's total revenue in the year ending March 31, bringing in $4.8 billion.

It should be noted that Avandia has never been identified as having an association, suspected or otherwise, with bladder cancer. Actos, on the other hand, approved by the EMA in 2000, has long been associated with a debate over the potential for bladder cancer, according to Reuters.

The concern over Actos and bladder cancer took root in a safety review launched last September by the US Food and Drug Administration (FDA), which indicated its intention to require additional warnings on the Actos label with regard to the potential for Actos bladder cancer in association with long-term use of pioglitazone (Actos). The EMA, meanwhile, initiated a similar review of its own in March of this year. Of interest to both agencies is a scientific study conducted in France that found a slight increase in risk for Actos bladder cancer.

In spite of its findings and its position, the EMA still regards Actos as a valid treatment option for some patients, and noted that the risk for this latest addition to Actos side effects could be tempered through careful patient selection, and periodic reviews of Actos safety and efficacy for individual patients.

According to Reuters, Takeda signaled that it plans to update the Actos warning label once the EMA recommendations were endorsed by the European Commission.