Actos and Bladder Cancer-Definite Link; Whistleblower Helps Case

UPDATE March 2012 A lawsuit has been filed by whistleblower Helen Ge, a former reviewer for Takeda Pharmaceuticals. It has recently been unsealed and indicates the drug company told reviewers to conceal information about actos and bladder cancer and actos and heart disease. This information should help the victim lawsuits over actos. UPDATE August 2011 Lawsuit filed by my husband which will be part of a class action lawsuit. JUNE 2011 - The FDA is placing a warning on Actos that it may cause bladder cancer. France and Germany have banned the drug. Victims are filing lawsuits. Watch for more updates.

On September 17, 2010. The FDA announced “the drug Actos for diabetes may be linked to a higher risk for bladder cancer and warrants further study”. This information. based on two 10-year case studies,still ongoing, also indicated that, in preclinical trials. male rats developed bladder tumors.. Victims received instructions in the news article to contact the FDA about any adverse reactions from Actos.and to contact physicians for any further recommendations. FDA.org provides information along with other medical websites.The hotline FDA number is1-800-FDA-0178.

Actos has a black box warning, stating that heart failure and liver disease patients should avoid the drug. There are numerous other side effects shown at the website of WebMD Bladder cancer is not mentioned.The drug was introduced in 1999 to help diabetes patients by reducing insulin resistance.The drug is also called Pioglitazone and along with the drug, Avandia, is in a class called thiazolidenidione medications

Avandia is the only other drug in the same family as actos, and evidence shows increased cardiac risk for that diabetes drug. As of 9/23/10, the FDA has placed limits on that drug. Patients must sign a release form stating that they understand the risks of the drug. New patients cannot take the drug unless another diabetes drug has not been successful. Some patients who were on Avandia have already filed lawsuits based on cardiac problems

Many consumer groups have advocated more stringent monitoring by the FDA before drug approval. Many of the drug companies spend money on marketing drugs with TV ads and other methods. At one time in the past, this type of marketing was very limited. Consumer groups advocate a critical need for adequate money for research to make drugs safer and find new drugs.

Drugs are good and sometimes deadly. The FDA attempts to do a good job, but often politics and money become influential in the decisions. The drug companies could improve the situation by spending more money on research and reporting findings honestly, without cover-ups. At least, consumer groups work diligently to ensure better results. Everyone needs to join hands and fight for better medicine. A patient’s survival for just one more year or one more month or even one more day, would bring endless joy to everyone.

.

My husband may be a victim of the problem with actos, as he has bladder cancer and is on the drug Actos.He telephoned the report to the FDA, and is awaiting the form to complete for them. The dosage of Actos is 15 milligrams daily.. In February 2009, a urologist diagnosed the cancer and he underwent surgery for Stage 1 bladder cancer.At this time, he had been on Actos for four years, and there was nothing on the Actos blurb about bladder cancer or male rats with tumors. His cancer is on the wall of the bladder with no incidence elsewhere. He underwent chemotherapy called BCG and has follow up checks every three months, then six months, and then yearly.

In October 2009, a few spots showed up, and they were removed, and he underwent more chemotherapy It is now September 2010, and he is in remission and is on the three-month checkup period. Some physicians indicate that bladder cancer grows slowly and that older men who are victims usually live a normal life span.This may be speculation, but we hope it is true.I reordered the drug printout and found no notation of bladder cancer in male rats, so we were clueless about this fact. I did find a webpage entry on the Internet from 2009 which mentioned it, so this information eluded us..

Bladder cancer is not a disease that is prevalent in my husband's family, Heart disease runs in my side of the family, so this was a new experience. We thought it would never happen to us. The experience was very frightening. First, the surgery took place, and everybody sat in the waiting room hoping for the best. We have already been through open-heart surgery with my husband, and we survived that ordeal. However, the cancer word is a mystery word. The prognosis is unknown.

So what do we do now? Do we become angry with the drug company about inadequaate information about Actos or the FDA or the prescribing physician? Or do we just accept it as being a part of life?. Do we file a lawsuit? The answers are unknown. We may never know if the drug caused the bladder cancer. On September 25, 2010, he started a new drug Metformin, following a telephone call to his physician..

Probably many people have found themselves in similar situations to ours, and deserve compassion for their ordeals. It may be another drug that caused their problems. I also feel sorry for the people who pay no attention to the news and barely make it on their own. Who tells them about situations like this? How do they handle their medications and side effects and all the compound problems that may occur?. It makes a person feel grateful to have the skills to handle situations.

What have we learned from this experience that might help others?. One, is to always read the drug brochure thoroughly and question anything that does not seem quite right. Also, we must pay attention to any changes in our bodies after beginning a new medication. We have a great pharmacist whom we call about any interactions, even with herbs, so being in touch with the pharmacist.is important. We know now to check with the FDA website if questions arise, and to be inquisitive with physicians. If a brochure stated that bladder tumors were found in preclinical trials of a drug, we would not take the medicine. The most important lesson is that no matter what circumstances or crises arise, we need to take charge of our own health, because no one else will do it for us. We need to stay informed by reading and asking questions and insisting on answers without relying solely on physicians' advice or information about medication.. We need to be ready to challenge facts and think outside the box, to ensure better and safer lives for ourselves and others.