Generic Pyrimethamine Tablets for Toxoplasmosis Granted FDA Approval

The FDA has approved an application for the first generic version of pyrimethamine tablets (Daraprim, Cerovene) when used with a sulfonamide, a group of medicines used to treat bacterial infections. Pyrimethamine is indicated for the treatment of toxoplasmosis, an infection caused by the parasite Toxoplasma gondii.

If severe, toxoplasmosis can cause damage to the brain, eyes, or other organs. A T. gondii infection can occur by eating undercooked, contaminated meat, or shellfish; drinking water contaminated with the parasite; or by accidental swallowing of the T. gondii through contact with cat feces that contain it.

Pregnant women and individuals who have weak immune systems, such as those with HIV or AIDS, those taking certain types of chemotherapy, and those who have recently received an organ transplant are the most likely to obtain severe toxoplasmosis. However, a person with a healthy immune system may experience eye damage from toxoplasmosis.

The most common adverse effects for pyrimethamine include hypersensitivity reactions that can be occasionally be severe, toxic epidermal necrolysis, erythema multiforme, anaphylaxis, and hyperphenylalaninemia. In addition, anorexia, and vomiting may occur with doses of pyrimethamine used for the treatment of toxoplasmosis.

Doses used in toxoplasmosis may produce megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm. Moreover, hematologic effects may occur at low doses in certain individuals, according to the FDA.

REFERENCE

FDA approves first generic of daraprim [news release]. Silver Spring, MD; FDA: February 28, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-daraprim?utm_campaign=FDA%20approves%20first%20generic%20of%20Daraprim%20%28pyrimethamine%29%20tablets&utm_medium=email&utm_source=Eloqua. Accessed February 28, 2020.