The U.S. Food & Drug Administration (FDA) has issued a warning stating that the long-term use of Takeda’s popular diabetes drug Actoplus Met (pioglitazone and metformin) comes with an increased risk of bladder cancer. Although the vast majority of the coverage in the news has focused on Actos (pioglitazone HCL), the FDA has also warned that the use of Actoplus Met and Actoplus XR may increase the risk of bladder cancer. Signs and symptoms of Actoplus Met-induced bladder cancer may include blood in the urine, pain during urination (dysuria), and frequent urinary tract infections.
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What’s the problem with Actoplus Met?
Manufactured and marketed by Takeda Pharmaceuticals, Actoplus Met is the brand name for tablets that combine Actos (generic: pioglitazone) and metformin hydrochloride. Actoplus Met was approved for use on the U.S. market in August 2005. Also like Actos, mounting research and numerous case studies have shown that the long-term use of Actoplus Met may increase the risk of the user developing bladder cancer. In addition to Actoplus Met and Actos, other type 2 diabetes drugs containing pioglitazone include Actoplus Met XR and Duetact.
Actoplus Met Bladder Cancer Symptoms
Bladder cancer is typically caused by a cancerous tumor in the bladder, an organ in the center of the lower abdomen whose function it is to hold urine. The disease usually begins when cells lining the bladder grow out of control and form a growth. These tumors are classified by the way they grow – papillary tumors have a wart-like appearance and are attached to a stalk, while nonpapillary tumors are less common but more invasive and typically have a worse outcome.
The most commonly reported Actoplus Met bladder cancer symptoms include:
- Blood or blood clots in the urine (hematuria)
- Pain during urination (dysuria)
- Urinating small amounts frequently
- Frequent urinary tract infections (UTIs)
Symptoms that may be indicative of a more advanced form 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)
Telltale signs that develop when bladder cancer has spread include:
- Weight loss
- Bone pain or pain in the rectal, anal, or pelvic area
The FDA is advising physicians not to prescribe Actoplus Met to patients with a history of bladder cancer or in individuals with undiagnosed macroscopic haematuria, and to assess the bladder cancer risk prior to beginning a regimen of Actoplus Met. Taking age-related factors into consideration (especially bladder cancer, fractures and heart failure), the risks vs. rewards of taking Actoplus Met should be weighed carefully before initiating and during treatment of the elderly. Prescribing doctors should review the treatment of patients on Actoplus Met regularly to ensure that they are deriving sufficient benefits from the drug.
Actoplus Met Side Effects
In addition to the risk of bladder cancer, Actoplus Met side effects may include:
- Congestive Heart Failure (CHF)
- Heart attack
- Liver problems
- Macular edema
If you are taking Actoplus Met
Before taking Actoplus Met, consult your physician if you:
- are allergic to pioglitazone
- have severe heart failure or heart disease
- have diabetic ketoacidosis
- have a history of stroke or liver disease
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If you are currently taking Actoplus Met, always be sure to monitor your blood sugar levels closely. Low blood sugar (hypoglycemia) can easily occur if you skip a meal, exert yourself physically, consume excessive amounts of alcohol, or suffer from high levels of stress. Signs and symptoms of hypoglycemia may include:
- trouble concentrating