Recently, the Institute for Safe Medication Practices released the October QuarterWatch report that details the increase in reports of drugs with serious adverse side effects to the FDA. It discusses type 2 diabetes drug Actos, which has recently been associated with cases of bladder cancer development.
The report reviews the studies conducted prior to its official release, in which marked signals associated with increased risk of bladder cancer were identified in rats. The first assessment in 1999 found that rats fed pioglitazone (Actos) experienced “multiple toxicities” in vital organs, including the bladder1.
Actos has been linked to other potentially fatal side effects, including:
- Congestive heart failure
- Liver problems
- Bladder cancer
In 2003 the FDA issued a ten-year study to further examine the bladder cancer association. The 5-year interim results demonstrated an increased risk of bladder cancer in subjects who had taken the drug for two years or longer, but not among those who took the drug less than two years1.
“Marked signals have now been seen in animal data, clinical trials, epidemiological studies and reported adverse drug events..cancer risks from prescription drugs are likely to develop over many years and are notably hard to document,” the Institute for Safe Medication Practices said1.
Since 2011, however, the FDA has received 1,025 reports of bladder cancer among Actos users. 71 percent of these complaints came from consumers, while 29 percent came from healthcare professionals1.
1 Institute for Safe Medication Practices. QuarterWatch: Monitoring FDA MedWatch Reports. Why Reports of Serious Adverse Drug Events Continue to Grow. October 3, 2012. PDF.http://www.ismp.org/quarterwatch/pdfs/2012Q1.pdf