Actos Needs New Cancer Warning

(Bloomberg) — Takeda Pharmaceutical Co.’s Actos diabetes drug may be kept on the market with new warnings, the European Medicines Agency said after reviewing research showing the drug carried a slightly increased risk of bladder cancer. The benefits of pioglitazone, the active ingredient in Actos and other diabetes treatments, outweigh its risks in a limited […]

(Bloomberg) — Takeda Pharmaceutical Co.’s Actos diabetes drug may be kept on the market with new warnings, the European Medicines Agency said after reviewing research showing the drug carried a slightly increased risk of bladder cancer.

The benefits of pioglitazone, the active ingredient in Actos and other diabetes treatments, outweigh its risks in a limited group of patients with Type 2 diabetes, the London-based agency’s Committee for Medicinal Products for Human Use said yesterday in a statement on its website.

“These medicines remain a valid treatment option for certain patients with type 2 diabetes,” though there is a small increased risk of bladder cancer, the agency said. The risk could be reduced by “appropriate patient selection and exclusion,” including regular reviews of how well the drug is working for individual patients, the agency said.

The European agency’s backing supports the decision made by the U.S. Food and Drug Administration that Actos wasn’t linked to an overall increased cancer risk in all patients who took it. Actos had sales of 387.9 billion yen ($5 billion) in the last fiscal year, accounting for 27 percent of revenue. That makes it the best-selling product for Osaka, Japan-based Takeda, Asia’s largest drugmaker.

The European agency has been reviewing the possible cancer risk of Actos and other medicines containing pioglitazone since March. France’s drug regulator in June said it would pull Actos from the market, and its counterpart in Germany recommended that the EMA suspend marketing approval for the diabetes medicine throughout the 27-nation European Union. Actos was suspended in Mauritius.

Shares Gain

Takeda rose as much as 0.5 percent in Tokyo trading, and was 0.3 percent higher at 3,725 yen at 9:09 a.m. local time. The benchmark Topix Index advanced 0.9 percent. The shares have declined 6.8 percent this year.

Actos, which faces competition from cheaper, generic versions next year, became the world’s biggest-selling diabetes drug after a 2007 study linked rival pill Avandia, sold by London-based GlaxoSmithKline Plc, to a higher chance of heart risks. The EMA in September suspended sales of Avandia, while the U.S. regulator decided the medicine could continue to be sold with new warnings.

Both pills belong to the same drug class as Rezulin, which was made by Warner-Lambert Co. It was pulled from the market in March 2000 because of risks of liver cancer and sudden death. The Glaxo medicine had revenue of $680 million last year, less than half its peak in annual sales.

‘Stop Taking Actos’

Some doctors have already stopped prescribing Actos and other so-called thiazolidinediones, or TZDs, partly because patients are nervous about the risks.

Besides heart risks, the drugs have also been associated with fluid retention, weight gain and bone loss, said Neale Cohen, an endocrinologist at the Baker IDI Heart and Diabetes Institute in Melbourne.

“I don’t think doctors are going to continue to prescribe TZD-class drugs, and as far as my practice is concerned, I will tell my patients to stop taking Actos,” said Albert Levy, an endocrinologist at Mount Sinai in New York, in an e-mail. Levy has already taken his patients off Avandia, he said.

Deciding how to assess the benefits versus risks of TZDs is key, said David Kendall, the chief scientific officer of the American Diabetes Association. Patients who can’t control their blood sugar are at risk for more-serious complications of diabetes, such as blindness and the loss of limbs, Kendall said.

 

Leave a Reply

 

Anti-Spam Protection by WP-SpamFree




Follow Us on:

Contact Us

Privacy Policy

Please click here to view our privacy policy.