Takeda Pharmaceuticals’ popular type 2 diabetes drug Duetact has recently been linked to an increased risk of bladder cancer in users who take the drug for a year or longer. According to a warning issued by the U.S. Food & Drug Administration (FDA), patients taking pioglitazone (the active ingredient in Duetact) for an extended period of time have a heightened likelihood of developing cancerous tumors of the bladder. Signs and symptoms of Duetact-induced bladder cancer may include blood in the urine, pain during urination (dysuria), and frequent urinary tract infections (UTIs).
Manufactured and marketed by Takeda Pharmaceuticals, Duetact (glimepiride & pioglitazone) is a type 2 diabetes drug structurally similar to Actos, which is the brand name for pioglitazone in the United States. The glimepiride component of Duetact helps to increase the amount of insulin created by the pancreas, while pioglitazone works to increase the sensitivity of insulin receptors. This helps the body respond better to its own insulin and regulates blood sugar levels.
Duetact & Bladder Cancer
Along with Actos and Actoplus Met, Duetact has been included in a list of pioglitazone-containing medications that have been associated with bladder cancer. On June 15, 2011, the FDA issued a safety warning stating that taking Duetact or other drugs containing pioglitazone for a year or longer has been correlated with an increased likelihood of developing cancerous tumors of the bladder. The warning states:
“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication pioglitazone for more than one year may be associated with an increased risk of bladder cancer.”
The administration is currently conducting an ongoing safety review of pioglitazone-containing drugs. Overseas, the European Medicines Agency (EMA) is calling for a pan-European study, which is intended to be focused on pioglitazone-associated risks.
Bladder Cancer Symptoms
Signs and symptoms of Duetact-induced bladder cancer may include:
- Blood or blood clots in the urine (hematuria)
- Pain during urination (dysuria)
- Urinating small amounts frequently
- Frequent urinary tract infections (UTIs)
Symptoms of a more severe variety of bladder cancer may include:
- Pain in the lower back around the kidneys (flank pain)
- Swelling in the lower legs
- A growth in the pelvis near the bladder (pelvic mass)
If bladder cancer has spread to other parts of the body, signs and symptoms may include:
- Weight loss
- Bone pain or pain in the rectal, anal, or pelvic area
According to the FDA warning, doctors should not prescribe Duetact to individuals with a history of bladder cancer, or in patients with undiagnosed macroscopic haematuria. The administration is advising physicians to assess the bladder cancer risk carefully before prescribing Duetact. Taking age-related variables into consideration, the potential benefits and risks should be weighed carefully by both doctor and patient before initiating treatment on the elderly. Prescribing physicians should review the treatment of patients on Duetact periodically to ensure they are responding positively to the medication.
Side Effects of Duetact
In addition to having the potential to cause bladder cancer, Duetact may also cause the following serious side effects:
- Congestive Heart Failure (CHF)
- Heart attack
- Liver problems
- Macular edema