If you took Propecia (finasteride) for hair loss or Avodart (dutasteride) for BPH, you probably did not realize you were trading a minor nuisance condition for the risk of a life-threatening illness or permanent sexual dysfunction. But drug manufacturers did. Evidence of the potential cancer risks for this class of drugs, called 5-Alpha Reductase Inhibitors or 5-ARIs, has been public since at least 2003, but researchers, many of them taking paychecks from pharmaceutical companies, have downplayed the risk. Sexual side effects have also long been known. If you suffered these types of adverse effects after taking these drugs you may be eligible for compensation for medical bills, lost wages, and diminished quality of life.
Drug companies make big profits marketing conditions first, then marketing drugs to treat them. This strategy tricks many people into trading a minor inconvenience for a major health risk. Your lawsuit may not only give you compensation, it can tell drug companies this strategy is dangerous and wrong. The attorneys of Techmeier Law Firm of Wisconsin are prepared to take up your case and fight for you. Please call or email us today to schedule your free case evaluation.
Failure to Warn of Sexual Side Effects
Sexual side effects were studied in original trials on these drugs, but seemed to subside over time with use. Unfortunately, it was discovered that a significant number of men experienced erectile dysfunction and decreased libido that persisted for months and even after treatment stopped. When Swedish drug regulators began investigating this problem in 2006 they were able to assemble enough evidence to convince the manufacturer to add the risk of persistent erectile dysfunction to labeling for the drug in Sweden. Labeling in Italy and the UK was also modified.
But the manufacturer never added information about this risk to the labeling used in the US, though it clearly had evidence this risk was significant, evidence it should have brought to the attention of US regulators.
Propecia and Avodart Cancer Risks Discovered
In June 2011, the FDA issued a Drug Safety Communication on Propecia, Avodart, and other 5-ARIs, stating that the drugs were associated with an increased risk of being diagnosed with high-grade prostate cancers. Ironically, this data came from two studies that were being used to test the active ingredients of these drugs for prostate cancer prevention. The active ingredient in Propecia, finasteride, was even recommended as an off-label prostate cancer prevention treatment. This recommendation was made even though some evidence suggested that the reduction of low-grade tumors was accompanied by an increase in high-grade, potentially life-threatening tumors. The risk of high-grade tumors was at the time simply explained away as an artifact of the studies.
The active ingredient in Avodart, dutasteride was also evaluated for the prevention of prostate cancer. It also showed the ability to reduce the incidence of prostate cancer, but with a similar risk for high-grade tumors. These results were initially reported to understate the risk of high-grade tumors.
FDA Evaluates Cancer Evidence
When the FDA evaluated these drugs to put prostate cancer prevention on the label of these two drugs, it went through a detailed analysis of the data from the prostate cancer prevention studies. Scientists concluded that although the drugs did reduce the incidence of prostate cancer, the reduction came from low-grade tumors, 80% of which are considered low-risk or very low risk. On the other hand, the increase in severe, potentially life-threatening tumors was considered very significant.
As a result, the FDA denied the indication for prostate cancer prevention for these drugs and instead required that they carry a warning of the danger for prostate cancer risks.
Why Choose Techmeier Law Firm Wisconsin for Your Drug Injury Lawsuit
Pharmaceutical companies aggressively market their drugs and hope to reap considerable profit from them. They are equally aggressive in trying to defend these profits from people who have suffered drug-related injury. To have the best chances of success against drug companies, you need a law firm that is equally aggressive in protecting your rights.
Techmeier Law Firm has a reputation for taking the cause of individuals and succeeding against seemingly impossible odds. Our nationwide network of lawyers also means that we have the resources to level the playing field with large corporations like drug manufacturers. Let us put our reputation and resources to work for you.
If you have been diagnosed with erectile dysfunction or prostate cancer after using one of these drugs, please contact Techmeier Law Firm of Wisconsin for a free case evaluation today.