Cancer patients were misled by Sanofi-Aventis to think it was a superior drug. The U.S. label took years to warn of the drug’s permanent hair loss side effect and only after the European counterpart. Learn more about a Taxotere Chemotherapy Drug Lawsuit.
Taxotere, also known as docetaxel and Docefrez, was touted by manufacturer Sanofi-Aventis as significantly better drug than its biggest competitor, but the Food and Drug Administration (FDA) rebuked the allegation in a 2009 warning letter saying it was “false or misleading” and it overstated the efficacy.
Greg Jones Law has sued many major drug manufacturers for failing to warn of the dangers of their drugs. To find out if you have a case against the makers of Taxotere, contact us today for a free case evaluation.
Sanofi-Aventis, furthermore, used to state in the chemotherapy drug label, which was first released in the U.S. in 1996, that the hair generally grows back after treatment is completed. However, this statement was quietly removed from the U.S. label in 2010 after the risk of alopecia or permanent hair loss was included in the European label of Taxotere in 2009.
Greg Jones law is currently taking cases from those who took Taxotere drug and developed Alopecia or permanent hair loss. If you or someone you know has been affected by this issue, please contact us for a free case review.
The manufacturer distributed reprints of promotional material published in the Journal of Clinical Oncology with a comparison of Taxotere to the leading competitor, overstating the drug’s efficacy by ignoring primary clinical analysis results. Instead, it used secondary studies of patient’s quality of life, which the FDA considered not substantial evidence.
The clinical study used in the medicine’s promotion, “failed to demonstrate statistical significance” and had not been replicated, warned the FDA in 2009.
Under the heading of “Unsubstantiated Superiority Claims / Overstatement of Efficacy”, the federal agency ruled that the reprint was “false or misleading” because it overstated the efficacy of Taxotere.
“Promotional materials are misleading if they contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug, when this has not been demonstrated by substantial evidence or substantial clinical experience. Furthermore, promotional materials are misleading if they contain representations that the drug is better or more effective than has been demonstrated by substantial evidence or substantial clinical experience.” – FDA warning letter to Sanofi-Aventis re Taxotere marketing, May 14, 2009.
Plaintiffs in Taxotere lawsuits had an alternative, naturally occurring, medication they could have been prescribed. However, because the side effects of the drug were unknown to them, and the benefits of the drug were greatly exaggerated at times, they were prescribed a medicine that caused them more pain and suffering.
To overstate the benefits of a drug for a very serious illness like cancer, that is used to save people’s lives, only to make more profits out of it, is preying on the patients.
Hair loss due to chemotherapy is usually a reversible effect of cancer treatments. Patients commonly have complete hair regrowth. Still, several studies have shown an incidence of permanent alopecia using docetaxel or Taxotere, especially breast cancer patients.
A study published in the Annals of Oncology in 2012 and another in 2011, for instance, linked permanent scalp alopecia of breast cancer patients with docetaxel in their chemotherapy treatment. The patients never had normal regrowth of hair.
American patients didn’t get to know about this risk even though Taxotere’s label included the permanent alopecia risk in the European label. This points to an awareness of this issue by the pharma company, which withheld information from the U.S. market.
The European label mentioned persisting alopecia beyond the end of chemotherapy and in follow-up period since 2009. The U.S. label was updated with a brief reference to persistent alopecia as a common side effect in December 2015.
Taxotere may cause other potentially serious reactions to the liver. Patients with liver damage or abnormal liver function could have a greater risk of dying while under this treatment, according to a FDA black box warning (most severe and possibly life-threatening side effects of a medication) added to the label in 2014.
The intravenous docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment, among other complications.
Greg Jones Law is taking cases nationwide for people claiming Taxotere caused them permanent hair loss. Our lawyers have taken to court many major manufacturers for failing to warn of the dangers of their medicines. These are very serious allegations and we stand with cancer patients for justice, working with attorneys across the country helping victims get compensated.
To find out if you have a case against the makers of Taxotere, call 855-566-3752 or contact us online today. We do not charge for initial consultations. If there is no recovery, you owe no legal fees. We are here to help you!