FDA OKs First Generic Version of Daraprim

March 2, 2020

Pyrimethamine (Daraprim) tablets are used to treat toxoplasmosis.

Officials with the FDA have approved the first generic version of pyrimethamine (Daraprim) tablets for the treatment of toxoplasmosis when used with sulfonamide, according to a press release.

According to the FDA, toxoplasmosis, an infection caused by the parasite Toxoplasma gondii, is considered to be the leading cause of foodborne illness in the United States.

Toxoplasmosis can be acquired through various ways, such as eating undercooked, contaminated meat or shellfish; drinking contaminated water, or by accidental swallowing of the parasite through contact with cat feces that contain Toxoplasma. When severe, infection can lead to damage to the brain, eyes, or other organs.

In particular, pregnant women and those with weakened immune systems are most susceptible to severe infection; however, even those with healthy immune systems may experience eye damage from toxoplasmosis.

“The FDA has a longstanding commitment to increasing competition in markets with limited or no generic alternatives,” FDA Commissioner Stephen M. Hahn, MD, said in a statement. “Through the FDA’s Drug Competition Action Plan, we’ve worked to remove barriers in generic drug development by not only taking actions that improve the efficiency of the development, review, and approval of generic drugs, but also by closing loopholes that allow brand-name drug companies to ‘game’ the rules in ways that delay generic competition that Congress intended.”

The most common adverse effects of pyrimethamine include hypersensitivity reactions that can occasionally be severe, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme, anaphylaxis, and hyperphenylalaninemia, particularly when pyrimethamine is given at the same time as sulfonamide.

The FDA also cautioned that, with doses of pyrimethamine used for the treatment of toxoplasmosis, anorexia and vomiting may occur. Doses may also produce megaloblastic anemia, thrombocytopenia, leukopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm. Hematologic effects may also occur at low doses in some individuals and there have been rare reports of pulmonary eosinophilia.

For patients with convulsive disorders, a small “starting” dose is recommended to avoid potential nervous system toxicity.

“Empowering patients and promoting choice and competition are top priorities for the FDA,” Dr Hahn said. “These important efforts include improving access to safe, effective, and high-quality generic medications.”

Hahn also noted that the approval is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS.

References:

1. FDA Approves First Generic of Daraprim [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-daraprim. Accessed March 2, 2020.