Many drugs are biochemically produced and manufactured chemicals which are prepared in laboratories for use to treat various diseases of humans and animals. In contrast, natural drugs are those produced or extracted from various living or dead organisms such as fungi, bacteria, plants or animals and these products are used for the treatment of human and animal diseases. There are also semi-synthetic drugs which are the products of organisms that are modified in the laboratory.
All new drugs for use in humans go through defined Food and Drug Administration testing phases and protocols before final approval for marketing and distribution to patients. Further, during the medical use of these drugs periodic reports and updates must be filed by the manufacturer to assure the safety and efficacy of the products in use. Actos® as a drug for diabetic patients was approved by the FDA in 2001 and has just recently been reported as a possible agent that causes increased risk of bladder cancer in some male and female diabetic patients using the drug.
Thiazolidinediones, Chemistry, Structure and Function
According to the National Diabetes Information Clearinghouse (NDIC) only two forms of this drug class have been used in prescriptions: pioglitazone (Actos®) and rosiglitazone (Avandia). In September, 2010 the FDA removed Avandia from the marketplace due to cardiovascular risks such as stroke and heart attacks associated with patients who used this drug.
Actos® – What Is It and What Does It Do?
Actos® is manufactured by Takeda Pharmaceuticals. Actos chemically is known as pioglitazone and is typically sold as a single ingredient or combination drug with metformin (Actosplus Met, Actoplus Met XR) and glimepiride (Duetact). The drug is used for type 2 diabetes mellitus control of blood sugar and together with a healthy diabetes diet and exercise regimen may help to promote better health. According to the FDA during a 10-month period in 2010 retail pharmacies in the U.S. filled U.S. about 2.3 million prescriptions for pioglitazone products.
Diabetic Conditions Treatable by Actos®
Actos® is in a class of drugs called thiazolidinediones. Actos® is effective for helping to maintain normal blood sugar levels in type 2 diabetic patients when used in the manner prescribed by a licensed physician.
Actos® Use and Effects on Diabetes and Doses
Pioglitazone as a thiazolidinedione apparently promotes the action of insulin and the entrance of sugar into cells. The drug decreases the levels of AC-1 which is a measure of glycosylation of red blood cells. An elevated AC-1 level is one indicator of pre-diabetes or actual diabetes.
Actos® Medical Warnings and Dangers
All drugs carry warning labels and in formation relevant to their use. Actos® has a number of potential or actual adverse effects as listed by the manufacturer according to signs and symptoms reported by patients who have used the medication.
Actos® Emerging Medical and Legal Issues
Based on various required filings and medical reports as well as medical research studies two serious types of adverse and increase-risk effects have been reported in some patients who use Actos:
- congestive heart failure – may cause or may worsen the condition
- bladder cancer ( with a 5 :1 male:female incidence ratio)
The U.S. study of 193,000 patients indicated that in patients who had used Actos® for a year or more had a 40% increased risk of bladder cancer. This finding and the study originating from France has resulted in three important actions:
- The US Food and Drug Administration (FDA) has issued a warning of the potential risk of bladder cancer for long-term users of Actos.
- The European Medicines Agency reported on issues related to pioglitazone medications on 09-06-2011.
- In France and Germany, the drug has been discontinued.
The FDA Consumer Safety Warning for Actos® requires the manufacturer to warn both healthcare professionals and patients as follows:
"healthcare professionals should:
- Not use pioglitazone in patients with active bladder cancer.
- Use pioglitazone with caution in patients with a prior history of bladder cancer."
"that patients should:
- Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer."
Sources
European Medicines Agency. "Update on ongoing European review of pioglitazone–containing medicines." Accessed 16, September, 2011 @ ema.europa.eu/ema/index
FDA. "FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer." Accessed 16 September, 2011 @ fda.gov/Drugs/DrugSafety/ucm259150.htm
FDA. "FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines." Accessed 17 September, 2011 @ fda.gov/Drugs/DrugSafety/ucm266555.htm
NDIC. "Thiazolidinedione." Accessed 17 September, 2011 @ diabetes.niddk.nih.gov/dm/pubs/medicines
Disclaimer: The information here is for presented general consumer education and review only and is not to be considered professional medical or legal advice. Those needing such advice should seek, qualified licensed medical doctors and legal professionals who can provide that expertise and guidance.
Donald Reinhardt - Think, read, write & live well always. DJR has a PhD in Biology/Microbiology & is a Fellow & Diplomate, ASM Amer Acad Micro.
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