New FDA Labeling Requirements for Actos Bladder Cancer Risk
On June 15th, 2011, the FDA released an important safety announcement regarding increased risk of bladder cancer associated with prescription medication Actos (pioglitazone). The results of an ongoing study revealed that patients who take the medication for one year or longer or in high dosages are more likely to develop Actos bladder cancer.
Hundreds of patients have reported bladder cancer-related Actos side effects; hundreds more are expected to file Actos lawsuits in the near future. Doctors in both the United States and Europe have been cautioned against prescribing Actos or pioglitazone-containing products for patients who have any history of bladder cancer.
Actos bladder cancer risks prompt new labeling requirements
On August 14th, 2011, the FDA approved a new labeling requirement, which mandated that both the Warnings and Precautions section of the medication packaging and the patient Medication Guide must now include information about the risk of developing Actos bladder cancer. These precautions advise health care professionals to avoid prescribing pioglitazone to patients diagnosed with active bladder cancer. Furthermore, the FDA recommends that doctors exercise caution when prescribing pioglitazone to patients with history of bladder cancer.
According to the new labels, physicians should prescribe other medications for blood sugar control unless the benefits clearly outweigh the increased risk of recurrence. Whereas Actos was once considered the go-to drug for adult patients with Type 2 diabetes, extreme concerns about the medication and its safety have led to a decrease in Takeda Pharmaceutical’s sales – which topped $4.3 billion in 2010 and 2011.
Actos side effects may indicate bladder cancer
Combined with a program of diet and exercise, Actos is prescribed to control blood sugars in adult patients with a diagnosis of Type 2 diabetes mellitus. Pioglitazone is also a key ingredient in otherTakeda products, including Actoplus Met, Actoplus Met XR and Duetact. Certain Actos side effects can indicate bladder cancer, including pain or urgency associated with urination, appearance of blood in the urine and lower back or abdominal pain. New Actos packaging advises patients who experience these symptoms to notify a health care professional. The appearance of these side effects and symptoms is especially troubling for patients who have turned to Actos to improve the body’s sensitivity to insulin. Instead, these patients have been warned to immediately report any 0f these symptoms to their prescribing physician.
In June of 2011, the Food and Drug Administration issued safety precautions about the recently discovered risk of Actos bladder cancer; hundreds of patients have since come forward. Many of those patients are worried not only about their health, but their legal rights as well. Those are the patients who have called the Actos lawsuit phone number for more information on the alarming issue.