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Federal health experts have approved the use of cooling caps, which are designed to help prevent hair loss due to chemotherapy treatments involving cancers with solid tumors, such as those linked to breast, lung, prostate and colon cancer.
The FDA issued a press release on July 3, approving the use of the Digni Cooling System to help prevent or reduce the effects of alopecia, a form of hair loss often associated with cancer treatments.
Alopecia can result in temporary or permanent partial or total hair loss, as well as thinning of the hair.
The chemotherapy hair loss prevention system was already approved in 2015, for breast cancer treatment, but the expansion this week approves its use during all solid tumor cancer chemotherapy.
“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” Binita Ashar, M.D., director, Division of Surgical Devices, in the FDA’s Center for Devices and Radiological Health, said in the press release. “Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”
The expanded approval comes following two studies published in February which found that women who received cooling cap treatments were less likely to lose hair following chemotherapy.
Both studies looked at women who had early-stage breast cancer, took place at several medical centers, and involved the use of a tight, fitted cap that used coolant to cool the scalp before and during each session of chemotherapy.
Chemotherapy Hair Loss Lawsuits
The research comes at a time when one particular chemotherapy drug, Taxotere, is the focus of increasing concern about problems with permanent hair loss that may continue long after the chemotherapy is complete. The manufacturer now faces a growing number of Taxotere lawsuits brought on behalf of women who allege the manufacturer failed to adequately warn about the risk of long-term alopecia, which is not associated with other, equally effective breast cancer chemotherapy drugs.
Taxotere (docetaxel) is a high potency taxane-based cancer drug, which was introduced by Sanofi-Aventis in 1996 as a superior alternative to existing low-potency taxanes, such as Taxol. However, lawsuits allege that the drug is actually no more effective at treating breast cancer, yet carries a risk of permanent hair loss, or alopecia, which has not been associated with low-potency taxanes.
While hair loss is a common side effect of chemotherapy, it is usually temporary. According to allegations raised in Taxotere hair loss cases filed in U.S. District Courts nationwide, Sanofi-Aventis provided false and misleading information for consumers and physicians in the United States, withholding reports of on-going hair problems experienced by users of the high-potency taxane.
Plaintiffs maintain that Sanofi-Aventis knew or should have known about the link between Taxotere and hair loss problems that continue for years following treatment, yet placed their desire for profits before consumer safety.
In October 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all Taxotere hair loss cases filed in federal courts nationwide consolidated in the Eastern District of Louisiana for pretrial proceedings.