Abilify Side Effect Warning
The Food and Drug Administration (FDA) has issued a black box warning regarding Abilify and an increased risk of death in elderly patients treated for dementia-related psychosis. The boxed statement also warns of an increased risk of suicidal thoughts and behaviors in children, adolescents and young adults who are taking Abilify.
New information has also emerged indicating an increased chance for compulsive behaviors in adults who take Abilify. Most notably, some users of Abilify have developed problems with self-destructive behaviors like gambling, hypersexuality and overeating. Abilify’s manufacturer Sanofi-Aventis is facing thousands of lawsuits for damaging side effects related to use of the medication.
Abilify Side Effects
Abilify (aripiprazole) is an atypical antipsychotic medication which is used to treat:
- Schizophrenia in adults and adolescents over the age of 13
- Bipolar I Disorder in adults and adolescents over the age of 10
- Major Depressive Disorder in adults
- Irritability associated with Autism in children and adolescents ages 6 to 17 years
- Tourette’s Syndrome in children ages 6 to 18 years
Abilify works by changing the activity of neurotransmitters or chemical messengers at certain receptors in the brain, mainly serotonin and dopamine. This may help to reduce psychosis and other behaviors and improve depression. Side effects may be caused by its activity in the brain but also by other effects in the rest of the body.
Common side effects of Abilify may include:
- Nausea and vomiting
- Coordination difficulties
- Weight gain
More severe or serious side effects may include:
- Hyperglycemia or worsening of diabetes
- Changes in blood cholesterol
- Orthostatic hypotension
- Changes in laboratory blood cell counts
- Changes in cognitive functioning
- Tardive dyskinesia (permanent and abnormal movements of face, arms, and body)
Abilify has been shown to increase the risk of compulsive behaviors. These may include risk-taking and harmful behaviors such as
- Binge eating
- Excessive spending
- Other risky behavior
Impulse-control behaviors may be associated with the underlying medical diagnosis such as bipolar disorder but may also worsen when taking Abilify. In most cases, discontinuing or reducing the medication will help to alleviate the symptoms but medication should not be discontinued without advice of a physician.
Abilify may increase the risk for cerebrovascular events including cerebrovascular accident (CVA) or stroke and transient ischemic attack (TIA), including those that lead to death. In addition, Abilify has been shown to increase the risk of death when used in elderly patients who have dementia-related psychosis. Increased risk may be associated with side effects of Abilify which cause difficulty swallowing or excessive tiredness which may increase the chance for aspiration, choking or accidental injury.
Abilify is not approved for treatment of symptoms of psychosis in dementia of the elderly.
Because Abilify is used to treat depression, it may increase the risk of suicidal thoughts and behaviors in children, adolescents and young adults up to the age of 24 years. This is particularly notable in the period after medication is started or when dosing is changed.
Patients who are taking medications used to treat depression, including Abilify, should be carefully monitored for suicidal thoughts and behaviors. Patients should also be monitored for symptoms that may indicate another mental disorder such as mania of bipolar disorder. Symptoms that should be reported may include:
- Manic behavior
Sudden occurrence of fever, muscle rigidity, irregular or rapid heartbeat, changes in consciousness level, excessive sweating or other sudden symptoms should be reported to a medical professional immediately as they may indicate a rare condition known as Neuroleptic Malignant Syndrome (NMS).
Abilify Lawsuits and Settlements
Bristol-Myers Squibb (BMS), manufacturer of Abilify, has been the subject of thousands of lawsuits. These lawsuits have been filed by Abilify users who claimed that the manufacturer failed to adequately warn them of serious side effects including:
- Gambling and compulsive behaviors
- Hyperglycemia and Type 2 diabetes
The manufacturer was accused of knowing the risks but failing to notify consumers or modify drug warnings even after regulators in Europe and Canada forced them to do so outside of the U.S. Prescribing information in the U.S. was not modified until the manufacturer was forced to do so by the Food and Drug Administration (FDA). Unfortunately, many Abilify users had already been subjected to increased risks.
The company has also been accused of promoting Abilify for unapproved or “off-label” uses. BMS paid $515 million in 2007 to settle a federal lawsuit for inappropriate or illegal marketing which included paying kickbacks to physicians who prescribed Abilify. In 2016, the company paid another $19.5 million to settle a lawsuit with 42 states for off-label marketing.
Bristol-Myers Squibb is facing over two thousand lawsuits filed by individuals who used Abilify and experienced severe or serious side effects. Federal Abilify lawsuits have been consolidated into multidistrict litigation (MDL 2734) in the U.S. District Court for the Northern District of Florida. Some of these cases may have been settled but no official announcements have been made and more lawsuits or cases may be expected.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.