FDA Warning Issued for Actos
FDA has issued a warning that there is an increased risk of bladder cancer in certain patients taking Actos. The risk seems to be considerably higher for those that take the drug at higher cumulative doses and for longer periods of time. Although Actos continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France and Germany have suspended the drug, due to the mounting concerns for its citizens.
You take medication to control your type 2 diabetes. But what about the potential risks of these prescription drugs? They cannot be seen or felt until it is too late. Actos is now being considered among such drugs.
Although Actos continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France and Germany have suspended the drug, due to the mounting concerns for its citizens.
FDA has issued a warning that there is an increased risk of bladder cancer in certain patients taking Actos. The risk seems to be considerably higher for those that take the drug at higher cumulative doses and for longer periods of time.
Possible signs or symptoms of Actos-related bladder cancer may include:
* Blood in the Urine
* Pain During Urination
* Feeling of Need to Urinate Without Results
* Pain in the Back or Lower Abdomen
Lawsuits are being reviewed nationwide as a result of the manufacturer’s failure to adequately warn about the potential risk.
FDA has asked the makers of Actos to issue a black box warning about the serious risk of adverse cardiovascular events, such as congestive heart failure. These changes are in addition to the existing FDA-required warnings regarding possible heart attack, arterial, hypertension, and stroke.
Note: A black box warning is the strongest FDA-requested label change that can be added to a drug.
The FDA is currently analyzing the clinical data regarding Actos to determine whether further regulatory action, such as an Actos recall, is warranted.
This medication may infrequently cause, or worsen, a certain heart problem (congestive heart failure). Tell your doctor right away if you notice any symptoms of heart failure, including: swelling of the hands/feet, unusual/sudden weight gain, trouble breathing, or unusual tiredness.
There are numerous side effects associated with the use of Actos:
- Sinus Infection
- Tooth problems
- Muscle Pain
- Sore throat
- Water retention
- Stomach pain
- Jaundice of the eyes
- Loss of appetite
- Vision Problems
- Shortness of breath
- Chest pain
Post-marketing studies have also shown that patients taking Actos are at an increased risk of suffering from related hepatitis, liver failure, inflammation of the liver, and elevated liver enzymes.
Actos Side Effects and Warnings Persist
The US Food and Drug Administration (FDA) has announced a potential safety issue regarding Actos (pioglitazone HCL) and rhabdomyolysis, a rare condition in which the muscle fibers deteriorate, and release into the blood flow.
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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.