Failure to Warn
Taxotere’s maker Sanofi-Aventis failed to warn American women in order to keep the profits from the drug flowing, according to Taxotere Lawsuit petitions filed against the French-based company. A whistleblower lawsuit brought by a company insider makes a similar claim, along with allegations that Sanofi-Aventis awarded doctors kickbacks to illegally incentivize use of the drug. Taxotere sales increased drastically during this alleged scam to withhold warnings from Americans, climbing from $424 million to $1.4 billion in four years. Consequently, Taxotere’s unnecessary toxicity was administered to thousands of patients when less toxic chemotherapy medications were readily available.
FDA Taxotere Warnings
The FDA did not require Sanofi-Aventis to add a warning about alopecia to Taxotere labeling until Dec. 2015, which means that most women wouldn’t have learned of the warning until well into 2016. There is always some lag time between FDA pronouncements and their delivery to doctors and their patients. At that time, the agency wrote under “adverse reactions” that “Postmarketing Experience” showed “Cases of permanent alopecia have been reported.” (emphasis ours)
That alopecia warning came much too late for thousands of American women who now suffer from permanent baldness.
Other FDA Warnings on Taxotere
- November 2014 – alcohol content could lead to intoxication
- December 2013 – Eye Disorders: Cystoid macular edema (CME) has been reported in patients treated with TAXOTERE and other taxanes. For metabolism and nutrition disorders, cases of hyponatremia reported.
- June 2013 – Respiratory: dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis have rarely been reported and may be associated with fatal outcome. Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
- May 2010 – Warnings for Use in Children (see the FDA safety info.)
April 2010 Summary View includes Renal Failure
Adverse reactions in post-marketing experiences included Scleroderma-like changes usually preceded by peripheral lymphedema, along with renal failure, most often associated with concomitant nephrotoxic drugs
Taxotere in Drug Combinations Cautioned
FDA also concluded that concomitant use of Taxotere and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with Taxotere, close monitoring for toxicity and a Taxotere dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided.
Women not Warned Taxotere causes Permanent Hair Loss
Sanofi-Aventis needs to be held accountable for misleading women (which we believe to be the case) into being injected with a drug that significantly raises the risk of permanent baldness. Approximately 10-15% of women who were administered Taxotere during chemotherapy reported zero hair growth for as long as ten years after stopping treatment.
Free Legal Consultation
Contact an experienced drug injury lawyer for a potential Taxotere Lawsuit if you or someone you love suffered permanent baldness after taking chemotherapy treatment. We offer a no-obligation free legal consultation.