New Study Links Chemotherapy Drug to Fatal and Severe Allergic Reactions

A chemotherapy drug used to treat breast cancer and other cancers has caused fatal and severe allergic reactions in hundreds of people over the last decade, new research says.

The drug, Cremophor-based paclitaxel, is a solvent-administered taxane chemotherapy. Between 1997 and 2007, there were 287 reports of hypersensitivity reactions from the drug sent to the Food and Drug Administration’s Adverse Event Report System. Of those reports, there were 109 deaths associated with the use of the drug, according to a new study from the Research on Adverse Drug Events and Reports pharmacovigilance program at Northwestern University Feinberg School of Medicine.

However, since adverse reports about all drugs generally only represent between one and 10 percent of actual incidence, the number of severe reactions and deaths linked to Cremophor-based paclitaxel is suspected to be much higher, the study said.

Reactions Caused by Chemical Solvent?

Researchers suspect that the severe allergic reactions and patient deaths are being caused by Cremophor, a chemical solvent derived from castor oil and used to dissolve the insoluble chemotherapy drugs before they can be injected into the patient’s blood stream.

Two patients who died after being treated with the drug to prevent cancer recurrence were women with early-stage breast cancer that had been surgically removed. This fact is particularly troubling since such women generally respond well to cancer therapy and lead long, productive lives after surgery, researchers said.

Nearly Two Dozen Deaths Noted

At least 22 patients died after having received drugs designed to prevent hypersensitivity to chemotherapy drugs. About 15 percent of those patients suffered from respiratory arrest, the study found.

In the past, hypersensitivity reactions to Cremophor-containing paclitaxel generally have ranged from mild skin conditions to deadly side effects including cardiac collapse and anaphylaxis, researchers said. The category of cancer drugs already carries a “Black Box” warning on the labeling to alert physicians and patients of the potential for injury from adverse reactions. Doses of corticosteroids and other medications before the chemotherapy drug is administered are recommended to reduce the risk of hypersensitivity reactions.

The researchers said patients receiving Cremophor-based paclitaxel should be monitored closely for signs of toxicity and that physicians may also want to consider alternative chemotherapy options that do not include the use of Cremophor.

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