See the DrugPatentWatch profile for sapropterin

Based on the information available, there is limited data regarding specific cognitive risks associated with Sapropterin, a medication used to reduce elevated blood levels of phenylalanine in individuals with a genetic disorder called phenylketonuria (PKU) [1]. However, it is important to note that PKU itself can lead to cognitive impairments if left untreated [2].

Sapropterin, also known as tetrahydrobiopterin, works by helping the body break down phenylalanine, an amino acid found in proteins. If phenylalanine is not properly metabolized due to a deficiency of the enzyme phenylalanine hydroxylase, it can build up in the body and cause harm, particularly to the brain [3].

The U.S. Food and Drug Administration (FDA) has approved Sapropterin for use in PKU patients who have a specific type of genetic mutation that responds to this medication [4]. Common side effects of Sapropterin include headache, diarrhea, vomiting, and nasopharyngitis (inflammation of the throat and nasal passages) [5].

While there is no direct evidence pointing to cognitive risks specifically associated with Sapropterin, it is crucial for patients to adhere to the prescribed treatment regimen and maintain a diet low in phenylalanine to prevent potential cognitive impairments [6].

In summary, based on the available information, there are no known cognitive risks directly associated with Sapropterin. However, PKU, if left untreated, can lead to cognitive impairments. Sapropterin is an FDA-approved medication for PKU patients with a specific genetic mutation, and it helps reduce phenylalanine levels in the body [1][2][3][4][5][6].

Sources:
[1] DrugPatentWatch.com. (n.d.). Sapropterin Dihydrochloride. Retrieved from https://www.drugpatentwatch.com/drugs/sapropterin-dihydrochloride
[2] National Institutes of Health. (2021, April 15). Phenylketonuria. Genetics Home Reference. Retrieved from https://medlineplus.gov/genetics/condition/phenylketonuria/
[3] National Institutes of Health. (2021, April 15). Phenylalanine hydroxylase deficiency. Genetics Home Reference. Retrieved from https://medlineplus.gov/genetics/condition/phenylalanine-hydroxylase-deficiency/
[4] U.S. Food and Drug Administration. (2018, January). KUVAN (sapropterin dihydrochloride) tablets for oral use. Retrieved from https://www.fda.gov/media/85131/download
[5] National Library of Medicine. (2021, May 1). Sapropterin. DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2d3e5e8e-8e1e-4e1f-a383-6f2e9b8a8d2f&type=display
[6] National Institutes of Health. (2021, April 15). Treatment of phenylketonuria. Genetics Home Reference. Retrieved from https://medlineplus.gov/genetics/condition/phenylketonuria/#treatment