FDA Approves First Generic of Daraprim | FDA

FDA Approves First Generic of Daraprim | FDA





FDA approves first generic of Daraprim (pyrimethamine) tablets

The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections).

The most common side effects for pyrimethamine include hypersensitivity reactions (immune responses) that can occasionally be severe, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (two forms of the same life-threatening disease that causes rash, skin peeling and sores on the mucous membranes), erythema multiforme (a skin disorder with bulls-eye-shaped lesions), anaphylaxis (a severe allergic reaction that may include difficulty breathing and shock) and hyperphenylalaninemia (elevated concentration of the amino acid phenylalanine in the blood), particularly when pyrimethamine is administered at the same time as a sulfonamide. With doses of pyrimethamine used for the treatment of toxoplasmosis, anorexia and vomiting may occur. Doses used in toxoplasmosis may produce megaloblastic anemia (a condition in which the bone marrow produces unusually large, structurally abnormal, immature red blood cells), leukopenia (low white blood cell count), thrombocytopenia (low blood platelet count), pancytopenia (low counts of white and red blood cells, as well as platelets), neutropenia (low level of the white blood cells called neutrophils), atrophic glossitis (a condition of the tongue), hematuria (the presence of blood in urine) and disorders of cardiac rhythm. Hematologic (blood) effects, however, may also occur at low doses in certain individuals. Pulmonary eosinophilia (inflammation of the lungs from an increase in the white blood cell eosinophils) has been reported rarely.

Pyrimethamine should not be used in patients with known hypersensitivity to pyrimethamine or with documented megaloblastic anemia due to folate (a naturally-occurring B vitamin) deficiency. Women who are taking pyrimethamine should not become pregnant. Patients should keep pyrimethamine out of the reach of children.

A small “starting” dose for toxoplasmosis is recommended in patients with convulsive disorders to avoid the potential nervous system toxicity of pyrimethamine. Pyrimethamine should be used with caution in patients with impaired renal (kidney) or hepatic (liver) function or in patients with possible folate deficiency, such as individuals with malabsorption syndrome, alcoholism or pregnancy, and those receiving therapy, such as phenytoin (an anti-epileptic drug), affecting folate levels.