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Actos (Pioglitazone HCl) which is marketed as Actos, Actoplus Met®, and Duetact®, was reported to be linked to an increased incidence of bladder cancer according to the FDA Safety announcement of September 17th.
While the ten year study did not show an absolute link between all taking Actos and bladder cancer, an increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.
If you believe you have been affected by Actos and you need assistance with filing a claim or want to be involved in any possible settlement, you can speak with someone now who is experienced with the tragedy of drugs that harmed when they were meant to heal.
Actos is a product of the pharmaceutical giant Takeda Pharmaceuticals, was the tenth best selling drug in the U.S. in 2008 with sales of over 2.4 Billion dollars. Many patients who had been on Avandia were switched to Actos believing it would be safer. Now, a study is showing it is not safer than Avandia. Those who have taken Actos and suffered a heart attack or other injury as the result of it deserve to be compensated.
Serious side effects include:
weight gain, due to fluid retention or extra body fat
nausea, stomach pain, unexplained tiredness, loss of appetite, dark urine, or jaundice that can signify liver problems
changes in vision, that can be symptoms of a serious condition known as macular edema
fractures in the hands, upper arms, or feet, especially in women
low red blood cell count
low blood sugar
ovulation, which can increase the chance of pregnancy
bladder cancer, which is characterized by blood or red coloration in your urine, an increased need to urinate, and pain while urinating
Alert your doctor immediately if you experience any of these serious side effects, or if common side effects persist.
Common side effects include:
cold-like symptoms
headache
sinus infection
muscle pain
sore throat
Warnings & Recalls for Actos
Serious Warning
In September 2011, the Food and Drug Administration launched an investigation after initial data from an ongoing 10-year study by Actos’s manufacturer, Takeda Pharmaceuticals, suggested that the drug might increase the risk of bladder cancer. A recent epidemiological study conducted by the French Medicines Agency, a national French insurer, also suggested a heightened risk of bladder cancer for Actos users. In June 2011, French regulators suspended distribution of Actos, and the FDA issued a black box warning for the drug.
The results of both studies show that, although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of cancer in those who had used the drug the most. There was also an increased risk of bladder cancer among users who had been exposed to the highest cumulative dosage of the drug. The FDA advises that people currently taking Actos should continue doing so until instructed otherwise by their healthcare professional. Those who are concerned about the risk of bladder cancer should talk to their healthcare provider. If you have already experienced complications associated with Actos, be sure to report your experiences and fill out our contact form to the right to get in touch with one of our Actos lawyers.
Black Box Warning
Some compounds found in Actos may cause or exacerbate congestive heart failure in some patients. Patients should be closely monitored for any rapid weight gain or edema, as these can be signs of this serious condition. Patients who have a medical history of symptomatic heart failure, or who have suffered from Class III or IV heart failure, should not take Actos.
Actos may also cause a rare but serious side effect known as lactic acidosis which is characterized by malaise, myalgias, respiratory distress, increasing somnolence, and abdominal pain. If you or someone you know suffer from these side effects while taking Actos, stop taking this medication and seek emergency medical attention immediately.
Patients who are pregnant or breastfeeding should exercise caution when using Actos, as there have been no established or well-controlled studies to examine the potential side effects this drug may have on unformed fetuses or nursing infants.
Actos Treatment and Use
Actos | Pioglitazone is part of the class of drugs known as thiazolidinediones and is manufactured by Takeda Pharmaceuticals as an oral tablet. Actos is designed to heighten the body’s sensitivity to insulin and, along with diet and exercise, control blood sugar levels.
Actos is indicated for the treatment of type 2 (or adult onset) diabetes. Actos is not for patients with type I (or “juvenile”) diabetes.
Actos Dosage
The recommended starting doses for Actos is as follows:
15 mg or 30 mg once daily in patients without congestive heart failure.
15 mg once daily in patients with congestive heart failure.
This dosage may be adjusted in increments of 15 mg over time, with a daily dosage not to exceed 45 mg once daily.
