Treatments of 5-fluorouracil (5-FU) cancer may cause life-threatening toxic effects in some patients with a particular enzyme deficiency. The Medicines Agency determines the screening, after complaints from four families of victims last February.
It's a victory for cancer patients. "5-FU" -based chemotherapy may now be prescribed only if a sensitivity test is performed, the Agence du médicament (ANSM) announced Monday, April 29. Anticancer drugs containing 5-FU, or its precursor capecitabine, are widely used in chemotherapy alone or in combination with other drugs. However, in some patients with a specific enzyme deficiency, the toxic effects of 5-FU increase tenfold because they do not eliminate the drug. It is then necessary to adjust the dose or use other molecules.
The test is done "by simple blood test and measurement of uracylemia by an analytical laboratory," which ensures that the enzyme works properly, says the ANSM.
A test at 40 euros, reimbursed by health insurance
Specifically, the prescribing physician should mention "uracilemia results taken into account" in its prescription, and the pharmacist who delivers the product must ensure "the presence of this mention prior to dispensing." USAinformations, who revealed the information, said the test costs 40 euros and will be reimbursed by health insurance.
In February, Four families of victims of the toxicity of this molecule – including three fatal cases – have filed a complaint against X. They criticize health authorities for not having previously recommended this test, which has been practiced for several years by some hospitals. It was in December 2018 that authorities recommended the systematic implementation of the test to identify patients at risk before starting treatment.
"It took 19 years to successfully complete a test that would save the lives of thousands of people"
However, according to Céline Lis-Raoux, president of the RoseUp Cancer Association, interviewed USAinformationsThe first pharmacovigilance alert about the dangers of 5-FU dates back to 2000. "That means it took 19 years to successfully complete a test that could have saved the lives of thousands of people," he said. -is.
Every year, in France, about 90,000 people with cancer – mainly digestive, breast or otolaryngology – are treated again with 5-FU, according to the National Cancer Institute (INCa). According to the ANSM, between 0.05% and 0.1% of the population has a complete deficiency of the enzyme in question (DPD), and from 3% to 8%, a partial deficit. The European Medicines Agency (EMA) initiated a "re-evaluation" of 5-FU, at the request of the French drug agency, to "strengthen the conditions of use" mentioned in the marketing authorizations.