From the FDA Drug Label
The development of cataracts was observed in association with quetiapine treatment in chronic dog studies [see NONCLINICAL TOXICOLOGY (13. 2)] . Lens changes have also been observed in adults, children, and adolescents during long-term quetiapine treatment, but a causal relationship to quetiapine use has not been established. In dogs receiving quetiapine for 6 or 12 months, but not for 1 month, focal triangular cataracts occurred at the junction of posterior sutures in the outer cortex of the lens at a dose of 100 mg/kg, or 4 times the MRHD of 800 mg/day on mg/m2 body surface area.
Cataract formation has been observed in association with quetiapine treatment in animal studies, specifically in dogs. However, a causal relationship between quetiapine use and cataract formation in humans has not been established.
- Lens changes have been observed in adults, children, and adolescents during long-term quetiapine treatment.
- It is recommended to examine the lens by methods adequate to detect cataract formation at initiation of treatment or shortly thereafter, and at 6-month intervals during chronic treatment 1.
From the Research
Quetiapine (Seroquel) is unlikely to cause cataracts, according to the most recent and highest quality study available. The study published in 2016, 2, found no significant association between the use of quetiapine and the risk of cataract development in patients with schizophrenia. This study had a large sample size and used a nested case-control design, which provides strong evidence for the lack of association between quetiapine and cataract development.
Key Points to Consider
- The 2016 study 2 is the most recent and highest quality study available, and it found no significant association between quetiapine and cataract development.
- Other studies, such as the 2004 study 3, have also suggested that the risk of cataract development associated with quetiapine is low.
- The 2024 study 4 found that cariprazine, another atypical antipsychotic, was associated with cataract-related ocular adverse reactions, but quetiapine was not.
- Regular eye examinations are still important for patients taking quetiapine, particularly if they are on the medication for extended periods.
Recommendations for Patients Taking Quetiapine
- Attend scheduled eye exams and report any vision changes, such as blurriness, glare sensitivity, or difficulty seeing at night, to your healthcare provider promptly.
- Discuss the benefits and risks of quetiapine treatment with your prescribing physician, including the potential risk of cataract development.
- Consider the results of the 2016 study 2 and the lack of association between quetiapine and cataract development when weighing the risks and benefits of treatment.