Study Links Taxotere Side Effects to Epiphora and Optic Neuropathy

A new study adds to growing evidence that Taxotere side effects can cause epiphora and optic neuropathy, resulting in long-term vision problems for breast cancer patients after receiving the chemotherapy drug.

Researchers with the University of British Columbia, in Canada, found that Taxotere causes excessive tearing and watery eyes by a factor of seven, resulting in a medical condition known as epiphora. It also increased the risk of optic neuropathy, or damage to the optic nerves, by more than four-fold.

The study was released as a preprint version and has not yet been peer-reviewed, but may provide additional evidence in a growing number of Taxotere eye damage lawsuits being brought by former patients who have been left with this condition.

Taxotere (docetaxel) is a chemotherapy injection introduced by Sanofi-Aventis in May 1996, as a treatment of individuals with locally advanced or metastatic breast cancer. However, it is one of a number of treatment alternatives, and plaintiffs allege that they would have used one of the safer alternatives if adequate warnings and information about the Taxotere side effects had been disclosed by the drug makers.

Over the past five years, Sanofi has been facing more than 12,000 lawsuits involving permanent hair loss caused by Taxotere, which is not a side effects associated with other available breast cancer treatment options. In that litigation, plaintiffs claim that false and misleading information was provided that suggested hair would regrow after chemotherapy treatment, and the cases have been centralized as part of a federal MDL (multidistrict litigation) in the Eastern District of Louisiana since October 2016.

More recently, more than a dozen new lawsuits over Taxotere eye side effects have been filed in various different U.S. District Courts nationwide, each involving similar allegations that users experienced excessive tearing and watery eyes, leading to permanent vision problems following chemotherapy.

In this latest study, researchers compared outcomes of new female users of Taxotere and the competing chemotherapy drug tamoxifen (sold under the brand names Nolvadex and Soltamox), looking for diagnoses of epiphora, optic neuropathy and cystoid macular edema. Both drugs belong to a class of cancer medications known as taxanes.

For epiphora, they looked at 1,824 Taxotere users and 16,395 tamoxifen users, finding users of both drugs faced more than a seven-fold increased risk of epiphora. For optic neuropathy, Taxotere and tamoxifen users faced four and a half times the risk. There was only a small increased risk for cystoid macular edema.

“In a cohort of women who were using taxane chemotherapy agents, there was an elevated risk of epiphora, optic neuropathy and a less precise increase in risk for cystoid macular edema,” the researchers concluded. “Ophthalmologists and oncologists should be aware of these adverse events in women with breast cancer who use these drugs.”

Last month the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all Taxotere epiphora lawsuits filed in federal courts nationwide before U.S. Jistrict Judge Jane Triche Milazzo, in the Eastern District of Louisiana. Judge Milazzo is currently also overseeing all of the Taxotere hair loss lawsuits as well.

As part of the Taxotere MDL process, Judge Milazzo will preside over discover and pretrial proceedings, and will likely schedule a separate series of bellwether trials to see how juries respond to evidence and testimony about the link between Taxotere and eye damage, which would likely be repeated in most cases. However, if Taxotere settlements for watery eyes and excessive tearing are not reached, or the litigation is not otherwise resolved, each individual case may later be remanded back to the U.S. District Court where it originated for future trial dates.