The Ministry of Food and Drug Safety said Monday it would add precautions on three mercaptopurine-containing treatments and collect industry opinions until Oct. 2.
The European Commission and the U.S. Food and Drug Administration recently disclosed safety information that mercaptopurine drugs showed high toxicity in patients with an infection, viral reactivation, and specific genes.
Mercaptopurine is used for lymphocytic leukemia, acute myelogenous leukemia, chronic granulocytic leukemia, and acute leukemia.
After reviewing the safety information released overseas, the ministry decided to add precautions on locally distributed mercaptopurine drugs.
In the domestic market, the government approved Daehan New Pharm’s Melcapto Tab. (for export), Union Korea Pharm’s Union Mercaptopurine Tab. (for export), and Korea United Pharm’s Purinetone Tab. (exported under the name Catoprine Tabs.).
The government plans to have the mercaptopurine suppliers insert an infection in the adverse drug reaction warnings. In Europe and the U.S., cases have been reported that some patients who took mercaptopurine showed bacterial infections, viral infections, and infections associated with neutropenia.
The additional general precaution will also include infection-related content. The use of mercaptopurine alone or in combination with other immunosuppressants, including corticosteroids, has raised susceptibility to viral, fungal, and bacterial infections.
The drugmakers will also have to put an extra note that physicians, before starting treatment with the drug, should check whether a patient has been exposed to a varicella-zoster virus and whether the patient has been infected with the virus.
Concerning hepatitis B, there will be a recommendation for a blood test before the start of treatment and inclusion of cases of neutropenic sepsis.
The companies will also have to state that patients with the NUDT15 genetic mutation will require a dose reduction, as they were at more risk of severe 6-mercaptopurine toxicity.
The NUDT15 mutation appears in 10 percent of Asians, 4 percent of Hispanics, and 0.2 percent of Europeans. The additional content will also include a statement that physicians may consider the test for NUDT15 genetic mutation before using mercaptopurine.
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