FDA OKs First Generic of Daraprim (Pyrimethamine) Tablets

Megan Brooks


March 02, 2020

The US Food and Drug Administration (FDA) has approved the first generic version of the antiparasitic drug Daraprim (pyrimethamine) for the treatment of toxoplasmosis when used with a sulfonamide.

The generic version of Daraprim tablets is made by Cerovene Inc.

Daraprim was in the headlines in 2015 when "pharma bro" Martin Shkreli, then CEO of Turing Pharmaceuticals, hiked the price of the lifesaving drug by 5000% (from $13.50 a pill to $750).

In a statement, FDA Commissioner Stephen M. Hahn, MD, said the FDA has "a longstanding commitment to increasing competition in markets with limited or no generic alternatives."

The approval of generic Daraprim is "especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS, by paving the way for more choices in treatment options," said Hahn.

The FDA notes that the most common side effects with pyrimethamine include hypersensitivity reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which can occasionally be severe; erythema multiforme anaphylaxis; and hyperphenylalaninemia, particularly when pyrimethamine is administered at the same time as a sulfonamide.

With doses of pyrimethamine used to treat toxoplasmosis, anorexia and vomiting may also occur. Treatment may also produce megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm. Hematologic effects may occur at low doses in certain individuals. Pulmonary eosinophilia has been reported rarely, the FDA says.

Pyrimethamine is contraindicated in patients with known hypersensitivity to pyrimethamine or with documented megaloblastic anemia due to folate deficiency. Women who are taking pyrimethamine should not become pregnant. Pyrimethamine should be stored out of the reach of children, the FDA advises.

The FDA also recommends a small starting dose in the treatment of toxoplasmosis 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 or hepatic function or in patients with possible folate deficiency, such as individuals with malabsorption syndrome, alcoholism, or pregnancy, as well as those receiving therapy that affects folate levels, such as the antiepileptic phenytoin.

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