Public Citizen Takes Aim at Actos Side Effects

Baltimore, MDPublic Citizen, the public affairs watchdog, is warning the public about the risk of Actos side effects. The organization is reportedly concerned about the link between Actos and bladder cancer, and the link between Actos and heart failure. Public Citizen, which issues a list of DO NOT USE drugs, has reinforced its earlier decision to add Actos to that list, following warnings about a potential link to bladder cancer.

According to the organization, whose DO NOT USE list appears on the website Worst Pills, Best Pills (www.worstpills.org), Actos is on the list of DO NOT USE drugs because of a long list of serious side effects, "of which bladder cancer is but the latest."

This is not the first time Public Citizen has taken issue with Actos, although in the past Actos was often mentioned alongside rival drug Avandia. In 2007, Public Citizen sent a letter to the US Food and Drug Administration (FDA) noting that it had obtained an internal FDA memo from 2002, which concerned heart failure in patients taking Avandia and Actos. According to that internal memo, the FDA had reports of 47 cases of heart failure requiring hospitalization. Of those, 25 were linked to Avandia and 22 to Actos.

Furthermore, Public Citizen noted that at the time the 2007 letter was written, the FDA had 1,182 reports of heart failure linked to Actos and Avandia. Of those, 689 involved Avandia, with 415 of those cases requiring hospitalization, and 493 involved Actos, with 388 cases requiring hospitalization.

The FDA has issued a warning that use of Actos for more than a year may be linked to an increased risk of bladder cancer. The warning came after the FDA received information from a study that showed an increased risk of bladder cancer in patients who took Actos for the longest and had the highest cumulative dose. The agency did not issue an Actos recall, although in France, sales of Actos were suspended after information about the link between Actos and bladder cancer was made available.

Lawsuits have reportedly been filed against Takeda Pharmaceuticals, maker of Actos. Initial arguments over consolidating the proceedings could be heard as early as December 2011.