Consumer Alert — Actos (pioglitazone) May Be Linked to Bladder Cancer For Long-Term Users
The U.S. Food and Drug Administration (FDA) has repeatedly warned the public of links between the diabetes medication Actos (pioglitazone) and bladder cancer, and between pioglitazone-containing drugs and heart failure.
Davis, Saperstein & Salomon, P.C., is currently investigating injury claims related to Actos and pioglitazone. If you have suspect your injuries were caused by this drug, contact our experienced personal injury attorneys immediately. Our drug injury lawyers have been helping consumers since 1981, and we may be able to help you. Davis, Saperstein & Salomon, P.C., serves drug injury victims in New York City and in New Jersey communities such as Teaneck, Newark, Elizabeth, Paterson, and Trenton.
Latest Warning from FDA: Actos May Be Associated With Bladder Cancer
In August 2011, the FDA said it approved a new label that included safety information advising that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer (1). The labels advise that healthcare professionals not administer pioglitazone to patients with active bladder cancer and that they use pioglitazone with caution in patients who have a history of bladder cancer.
The new guidelines apply to these prescription drugs:
- Actos (pioglitazone);
- Actoplus Met (pioglitazone/metformin);
- Actoplus Met XR (pioglitazone/metformin extended-release);
- Duetact (pioglitazone/glimepiride).
Background On Actos
Actos was approved on July 15, 1999, to be used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus (2).
From January 2010 through October 2010, approximately 2.3 million patients filled prescriptions for a pioglitazone-containing product from outpatient retail pharmacies, according to the FDA (2).
Symptoms and Precautions For Actos Users
Patients should contact their healthcare professional if they experience any sign of blood in their urine or a red color in the urine, or other symptoms, such as new or worsening urinary urgency, pain on urination, or pain in the back or lower abdomen since starting pioglitazone, as these symptoms may indicate bladder cancer, the FDA says (2).
Bladder cancer is estimated to occur in 21.1 per 100,000 persons per year in the United States and is thought to be higher in diabetics, according to the National Cancer Institute (5).
The warning issued in August 2011 is based on a five-year interim of a 10-year study of pioglitazone being conducted by the manufacturer, Takeda. The five-year results showed an increased risk of bladder cancer in patients who had the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone (2).
The FDA also cited a recent epidemiological study conducted in France that suggested an increased risk of bladder cancer with the use of pioglitazone. France has suspended the use of pioglitazone and Germany has recommended physicians not start pioglitazone in new patients based on this study (2).
In September 2010, the FDA said findings from studies in animals and humans suggested a potential link between Actos (pioglitazone) and a risk of bladder cancer that needed further study (3).
Heart Failure Concerns
In August 2007, the FDA announced that it was updating warnings, precautions and contraindications in prescribing information about Actos, Actoplus Met and Duetact to emphasize that pioglitazone may cause or exacerbate congestive heart failure, particularly in certain patient populations (4).
The agency warned that the drug should not be given to patients with established NYHA Class III or IV heart failure, and that patients given the drugs or whose doses were increased should be observed for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema).
Patients were to be advised that:
- Actos, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure.
- Patients should watch for and report to their healthcare professional any signs and symptoms of heart failure, including edema from fluid retention, shortness of breath or trouble breathing, unusually fast increase in weight, and unusual tiredness.
The FDA said in August 2011 that it was continuing to evaluate data from the manufacturer’s 10-year study of pioglitazone, which continues to examine a cohort of 193,099 patients with diabetes, and that the agency would conduct a review of the French study.
Contact EXPERIENCED NJ, NY and US Drug Injury Lawyers Today
If you have been injured by a pharmaceutical product such as Actos, you need experienced legal representation immediately. In New Jersey or New York, contact Davis, Saperstein & Salomon, P.C., for a free initial consultation. If we accept your case, you can be assured that we will work to recover the maximum compensation for your injuries and expenses. Our practice serves New Jersey communities such as Newark, Elizabeth, Paterson, Teaneck, Trenton and New York City.
Sources
- FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines. 8/4/11. U.S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm266555.htm. Accessed 10/4/11.
- FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer. 6/15/11. U.S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Accessed 10/4/11.
- FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure. 9/17/10. U.S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm. Accessed 10/4/11.
- Information for Healthcare Professionals: Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact). 8/07. U.S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124178.htm. Accessed 10/4/11.
- SEER Stat Fact Sheets: Bladder. National Cancer Institute Web site. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed 10/4/11.
Consult with your physician if you have questions concerning this medication. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.
Davis, Saperstein & Salomon, P.C. has been a pioneer in representing people injured by harmful prescription drug medications since 1997. Your case will be carefully evaluated by our onsite staff physician. Our Mass Tort and Defective Drug Section is headed by Partner Marc C. Saperstein has represented clients in their individual cases against pharmaceutical companies that manufactured the popular drug Fen-Phen. He was part of the diet drug trial team and also was counsel to the diet drug class actions brought in New York and New Jersey. The firm also participated in several class actions against Big Tobacco. Partner Samuel L. Davis heads our Orthopedic Device Section and he continues to be active in litigation against drug and medical device manufacturers including defective orthopedic implants such as knee, hip and shoulder prosthesis.
