Abilify Side Effects
Side effects associated with Abilify include those typically associated with antidepressant medicines, such as worsening depression or suicidal thoughts. Patients are considered to be especially vulnerable within the first few months of treatment or when a dosage is changed; younger patients are at higher risk.
Abilify has also been linked to compulsive behavior. In May of 2016, the FDA issued a safety warning reiterating concern over the issue. In particular, the warning addressed the drug’s potential to cause an uncontrollable urge to gamble, shop, eat or have sex. Impulse control warnings had been issued previously in relation in Abilify in Europe and Canada.
Among the more serious side effects of Abilify is an increased risk of death in elderly patients with dementia-related psychosis. Due to this risk, the drug is not approved for use with older patients experiencing dementia-related problems. This potential side effect is addressed in a black box warning, along with the increased risk of suicidal thoughts and behavior.
Abilify may also cause a stroke in older patients. It can trigger tardive dyskinesia — a condition resulting in uncontrolled body movements — which does not subside when Abilify is stopped. The drug can also increase blood sugar and fat levels, as well as lead to weight gain.
Other side effects include:
upper respiratory illness
Patients are advised to contact their doctor if they experience any of the following symptoms: thoughts of suicide or dying, worsening depression or anxiety, feelings of agitation or restlessness, panic attacks, trouble sleeping, aggressive behavior, manic behavior, other unusual changes in mood or behavior.
Abilify Black Box Warnings
The FDA has issued black box warnings for Abilify. Black box warnings represent the most severe warnings the government can impose, they alert patients and doctors to a medication’s serious and potentially life-threatening risks.
Most recently, with a May 2016 safety announcement, the FDA issued a warning about Abilify pertaining to impulse-control issues. The agency reported that some users of the drug experienced “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.”
While Abilify was already required to list “pathological gambling” as a reported side effect, the FDA noted that the labeling didn’t sufficiently represent the nature of the impulse-control related issue. Specifically, the agency wished to add the behaviors of “compulsive eating, shopping and sexual actions” to the list of risks.
Abilify also carries a warning related to the increased risk of death in elderly patients with dementia-related psychosis. The drug can increase the risk of death in such patients due to confusion and memory loss and as such is not approved for in the treatment of such patients. This was the subject of a 2016 legal settlement.
Abilify also carries the risk of suicidal thoughts or actions. The drug’s warning label notes that this risk is higher for some children, teens and young adults, especially within the first few months of treatment. Patients with a family history of mental illness may also be at a higher risk for having suicidal thoughts.