In clinical trials sponsored by the manufacturers of Saphris, the most common side effects reported by schizophrenia patients were the lack of ability to sit still or remain motionless, diminished oral sensitivity, lethargy, drowsiness, and weight gain.
All atypical antipsychotic medications also carry a "black box" warning, the FDA's stringent warning, alerting health care prescribers about an increased risk of death linked to off-label use of these drugs to treat behavioral problems in elderly individuals with dementia-related psychosis. Saphris is not approved for such patients.
Saphris is made by Schering Plough. Experts at FDA evaluated the data from studies performed by the pharmaceutical company and feel that the drug is safe and effective. The drug will be formally approved for clinical use but will most likely be available for release in a few months.
Consumers should be aware that out of the three clinical trials sponsored by the pharmaceutical company, positive results were only seen in two out of three trials. No long-term data are available and neither is it known if Saphris works in all patients with Schizophrenia or bipolar disorder. Very little data on the drug is available. Only time will tell if the drug is as good as Schering Plough claims.