Chemotherapy can cure cancer, prolong life in cancer patients, or provide palliative care for cancer patients. While chemotherapy is life-saving for some cancer patients, it always carries the risk of serious side effects.
These side effects may happen during chemotherapy and stop when treatment ends, or they may be permanent side effects that never go away. Permanent side effects from chemotherapy drugs can be so severe that they drastically alter the quality of life for patients treated with them.
Taxotere (docetaxel), which is manufactured by Sanofi-Aventis, is a chemotherapy drug commonly used to treat breast cancer, prostate cancer, lung cancer, stomach cancer, neck cancer, and head cancer. In 1998, Taxotere received approval as first-line treatment for metastatic breast cancer in women whose cancer returned even with treatment to prevent a recurrence.
However, Taxotere has some adverse side effects that were not fully disclosed by Sanofi-Aventis until 2014:
- Epiphora (watery eyes) caused by lacrimal duct obstruction
- Keratoconjunctivitis (dry eye syndrome, characterized by continually itchy eyes, swollen eyelids, and more eye floaters)
- Alopecia (permanent hair loss)
An abnormally high number of women treated with Taxotere for breast cancer experienced epiphora during or after chemotherapy. Epiphora can be successfully treated if it is diagnosed as soon as it develops.
However, if epiphora is not diagnosed and treated early on, then an eye condition called canalicular stenosis can develop. Canalicular stenosis is irreversible and permanent and can be treated only by an invasive medical procedure followed by lifelong maintenance treatment.
Since Sanofi-Aventis didn’t provide full and adequate warning about the side effects of Taxotere, patients undergoing chemotherapy who developed epiphora, as well as cancer survivors who developed epiphora after chemotherapy, didn’t know that their watery eyes were related to Taxotere.
Therefore, they didn’t have the critical information they needed to have their epiphora treated then (Taxotere could still be used after epiphora treatment). As a result, several thousand cancer survivors – mostly women with breast cancer – who received Taxotere during chemotherapy have developed canalicular stenosis.
If you had chemotherapy for breast cancer and have been diagnosed with canalicular stenosis, you may be entitled to compensation for the permanent damage and diminished quality of life you have suffered because of Sofani-Adventis’ failure to disclose epiphora as a side effect of Taxotere.
Hotze Runkle PLLC has successfully represented cancer patients who have sustained permanent damage from chemotherapy drugs, collecting over $100 million in damages for our clients. We are committed to holding Sanofi-Aventis responsible for their negligence in withholding critical information about the side effects of Taxotere and for false marketing.
Take our quiz to sign on with us to represent you against the makers of Taxotere.
What is Canalicular Stenosis?
Every day, the eye’s lacrimal gland continually produces basal tears, which are always present to lubricate, nourish, and protect the cornea by washing dirt and debris away. Basal tears shield the eye from harmful matter that could damage it.
Basal tears enter the eye through the canaliculus, upper and lower tunnels from the lacrimal gland (near the septum of the nose) to the tear duct. When something causes the canaliculus to close, canalicular stenosis occurs, and tears roll out of the eye onto the face.
Canalicular stenosis, which can be moderate or severe, causes tears to continuously run down the face.
Impact of Epiphora and Canalicular Stenosis on Chemotherapy Patients
The case for Taxotere’s role in cancer patients developing canalicular stenosis is compelling. Regardless of whether cancer patients had chemotherapy once a week, every two weeks, or every three weeks, there is a very high incidence of canalicular stenosis as a long-term side effect, especially in breast cancer patients.
However, research shows that metastatic breast cancer patients receiving weekly chemotherapy with Taxotere were much more likely to develop epiphora during chemotherapy than metastatic breast cancer patients being treated every two weeks or every three weeks. The evidence points to the conclusion that the more Taxotere a metastatic breast cancer patient received, the more likely they were to develop epiphora during chemotherapy.
Cancer patients receiving weekly chemotherapy with Taxotere also rated epiphora as one of the worst side effects because it drastically affected their ability to wear makeup, to read, and to drive, but epiphora was also a frequent side effect among cancer patients who received chemotherapy less often.
Treatment of Early-Diagnosed Epiphora
If epiphora is caught early during chemotherapy, a surgical procedure called bicanalicular silicone intubation can be done to prevent the canaliculus from completely closing off. With bicanalicular silicone intubation, semi-rigid, but flexible silicone stents are placed in the canaliculi to keep them from closing completely.
This procedure is usually temporary, lasting for several months, except in rare cases where they are placed long-term. Therefore, if epiphora was a known side effect of Taxotere, then it could have been diagnosed early during chemotherapy and bicanalicular silicone intubation could have been done to protect the canaliculi for the duration of the chemotherapy.
Treatment of Canalicular Stenosis
Once the canaliculi are almost or completed closed (stenosis), it is permanent and irreversible. The only treatment available is an expensive surgical treatment, called dacryocystorhinostomy (DCR), which involves the placement of a permanent Pyrex glass tube in the canaliculi to prevent blockage of basal tear flow.
DCR is an invasive surgical procedure that creates new drainage passages for basal tears. However, DCP has several risks, including:
- Extensive bleeding
- Noticeable facial scarring
- Infection
- Stent displacement that causes other ocular issues
- Abnormal nose tissue fusion
- Blindness caused by damage to the optic nerve or infraorbital vessels
In some cases of canalicular stenosis, DCP has not been an effective treatment, leaving the patient with no other remedy for the condition.
Recognition of Canalicular Stenosis as a Side Effect of Taxotere by Ophthalmologists
In 2000, Dr. Bita Esmaeli, an ophthalmologist, wrote an article for the American Academy of Ophthalmology entitled “Canalicular Stenosis Secondary to Docetaxel (Taxotere).” In the article, Dr. Esmaeli discussed the high occurrence of epiphora and canalicular stenosis among cancer patients being treated with Taxotere.
He noted that epiphora and canalicular stenosis were unknown side effects of Taxotere (Sanofi-Aventis did not list it as a side effect). His research showed that metastatic breast cancer patients who were receiving weekly chemotherapy were much more likely to experience epiphora early on in their treatment.
Dr. Esmaeli said that ophthalmologists and other eye care professionals should be closely monitoring the eye health of their patients who were receiving chemotherapy so they could intervene as soon as epiphora developed with bicanalicular silicone intubation to prevent canalicular stenosis from developing. He noted that cancer patients could continue treatment with Taxotere after the intubation without any further chance of damage to the canaliculi.
Sanofi-Aventis’ Disregard for Cancer Patients’ Long-Term Health
Despite the report by Dr. Esmaeli in November 2000, it would be 14 more years before Sanofi-Aventis fully disclosed all the side effects of Taxotere, including those with long-term and serious effects, like epiphora, dry eye syndrome, and alopecia.
In the meantime, cancer patients – especially women with metastatic breast cancer who were receiving weekly chemotherapy – being treated with Taxotere and their doctors, including eye health professionals, were unaware of the health monitoring that should have begun as soon as chemotherapy began.
Sanofi-Aventis, by not disclosing all the side effects of Taxotere, showed a willful disregard for the health of cancer patients being treated with their drug. This was not only deceitful marketing, but it was also negligence.
Like many pharmaceutical companies, Sanofi-Aventis put profit before safety. When cancer patients receive chemotherapy, they expect to be helped – either to be cured or to live longer – instead of being harmed.
When a drug like Taxotere causes harm through its undisclosed side effects, which are permanent and lifelong, long after cancer treatment ends, then its value as an effective cure is questionable. Had cancer patients and their doctors been fully informed about Taxotere’s side effects, they might have chosen alternative cancer treatments. However, they didn’t get that choice.
Take the Taxotere Lawsuit Quiz
If you had cancer and received chemotherapy that used Taxotere, you may be experiencing side effects that continue to persist. If you experienced epiphora during chemotherapy, and then were diagnosed later with canalicular stenosis, your condition was likely caused by Taxotere.
Drug defects are covered by product liability claims and lawsuits. When consumers don’t know about drug defects, they can’t make informed decisions about whether to take the drug. When damage occurs because of the defects, then consumers are entitled to compensation from the drug manufacturer.
Sanofi-Aventis misled cancer patients by not disclosing all of Taxotere’s side effects. Their negligence caused the side effects that you are experiencing from canalicular stenosis. They should be held accountable for their negligence.
Hotze Runkle PLLC represents Florida cancer patients who are suffering canalicular stenosis from Taxotere used in chemotherapy. We know we can’t restore the quality of life you’ve lost with your visual impairments, but we can get you justice in the form of compensation for the physical, emotional, and mental suffering you’ve endured as a result.
Find out if you qualify by taking the Taxotere Canalicular Stenosis Quiz. If you are eligible, you can sign on to have our firm represent you.