History and Background of Taxotere
There has been extensive research on Taxotere, providing a great amount of history and background on the drug. Taxotere is a type of chemotherapy that is made from taxanes, which stop cancer cells from reproducing. Taxotere is FDA approved for the treatment of breast cancer. However, this drug sometimes does not produce the benefits it is intended to and can lead to complicated side-effects. If you or a loved one has suffered because of Taxotere, it is pertinent that you
However, this drug does not always produce the benefits it is intended to and can lead to complicated side-effects. If you or a loved one has suffered because of Taxotere, it is pertinent that you contact an attorney to help ensure you are properly represented in recovering any damages you are entitled to.
Brief Taxotere History
There have been a number of different studies comparing Taxotere and Taxol since Taxotere was FDA approved. When consumers and health professionals make the FDA aware of false claims in marketing and unknown side-effects of the drug, the FDA will investigate. That could ultimately lead to change or a loss of FDA approval. In 2009, the FDA wrote a letter demanding that Sanofi, which is the manufacturer of Taxotere, “stop marketing Taxotere-based on false promises of better results.” Sanofi had been marketing Taxotere as more effective than Taxol, the competitor, and the FDA found in that letter that those claims were misleading.
Role of the FDA
From the late 1990s through 2010, there was no warning of permanent or persistent hair loss on the US Taxotere label. In fact, there was a statement that “hair generally grows back.” Between 2010 and December 2015, the Taxotere label removed the statement that hair generally grows back and did not address it. In January 2016, after an FDA investigation, Taxotere labels in the US were updated to warn of permanent hair loss.
The FDA sent a letter in 2009 demanding that Sanofi stops marketing Taxotere-based on the false promise of better results. They based that on data that Taxotere and Taxol were equally as effective at fighting breast cancer. In 2016, the patient counseling information was updated with a list of information for oncologists to discuss with the cancer patient. Now, the medication specifically warns of permanent hair loss with Taxotere use.
Typically, before the label of a product is updated, people are not necessarily on notice of the injury that can result from use. The failure to warn is often the crux of these product liability cases. When the FDA updates or requires a company to update their warning label, that can be a trigger that what the label now warns of has occurred. An individual may have a potential lawsuit against the manufacturer for not warning about it previously.
Role of a Lawyer
Before the FDA requires a manufacturer to update the warning label, a patient may have a failure to warn claim against the manufacturer. An attorney can help the individual file a lawsuit and allege that the company knew or should have known, based on clinical research and data that the company performed or that independent medical journals and associations performed, that the drug indicated a risk of permanent hair loss. Both the history and background of Taxotere can be used as further evidence when bringing forward a lawsuit involving the drug.