Abilify is one of the world’s most commonly prescribed drugs. Generally safe when administered and used properly, like most pharmaceuticals taking it is not without risks.
Abilify’s manufacturer has alerted medical professionals and potential users about many of its known possible side-affects. These warnings ensure everyone involved can make an informed decision about the drug’s benefits and risks and monitor for adverse reactions. However, some serious side effects identified in medical studies and through self-reporting by users – notably an increase in compulsive behaviours – were not publicized by Abilify’s maker until it was compelled by federal health authorities.
This extremely troubling delay in issuing warnings is now the subject of a mass tort litigation in Canada (and a similar class action lawsuit in the United States). If you or a loved one is taking or has taken Abilify and has experienced harmful side effects associated with its use, HSH personal injury lawyer Paul Miller can help you to identify whether you may benefit from taking part in this legal action.
Often used in combination with other medicines, Abilify (the brand name for aripiprazole) is a second-generation, atypical anti-psychotic that balances and stabilizes dopamine and serotonin levels in the brain. Initially approved to treat schizophrenia, the drug’s unique ability to adjust dopamine and serotonin levels rather than just blocking the brain’s receptors to these chemicals, made it a promising contender to treat other conditions.
Since 2002 health agencies around the globe have approved the drug to treat major depression, bipolar disorder (Type I), Tourette’s syndrome, and irritability related to autism. Abilify is also often prescribed “off label” to treat conditions such as anxiety disorders, ADHD, and general depression.
In 2009, Health Canada approved the drug for use in treating schizophrenia and bipolar (Type I) in people 13 years of age or older. Abilify’s use has skyrocketed since that time, with yearly prescriptions increasing from an estimated 3,000 in 2010 to over 1 million by 2013.
Clinical studies have found many side effects associated with Abilify. The most common in adults are: nausea and/or vomiting, constipation, upper respiratory illness, dizziness, blurred vision, headache, anxiety, insomnia, and restlessness (akathisia). In children, other common side effects include: feeling sleepy, increased or decreased appetite, weight gain, increased saliva or drooling, tremor, and muscle stiffness.
Other particularly serious side effects have been found to include: neuroleptic malignant syndrome (NMS), uncontrolled body movements (tardive dyskinesia), high blood sugar (hyperglycemia) and diabetes, orthostatic hypotension (decreased blood pressure), low white blood cell count, seizures (convulsions), strokes in the elderly. People suffering from dementia related psychosis and pediatric patients with depression are also warned not to take the drug as it has been found to increase their risk of death.
Although these side effects mean the drug should be administered with caution, Health Canada’s 2009 review of data on quality, safety and efficacy of Abilify resulted in a favourable benefit/risk profile. Many people use it without incident and are aware of what types of side effects they might experience.
Abilify’s makers have been less forthcoming about other serious side effects, however. The drug has been linked to impulse control issues – gambling, binge eating or compulsive eating, compulsive shopping and hypersexuality – among some of its users. These side effects may be especially prevalent in, but not limited to, people with personal or familial histories of obsessive-compulsive disorder (OCD), alcohol and drug abuse, bipolar disorder, and other types of impulsive personalities or addictive behaviours.
Although warnings about these types of harmful side effects were present in Europe since 2012, Abilify’s manufacturers resisted publicizing this information in its promotional materials and packaging until Health Canada issued a summary safety review in late 2015.
The absence of these types of warnings and the use of promotional material with the United States’ Food and Drug Administration has termed “false or misleading” has likely contributed to the drug’s popularity and success. It has also put uninformed Abilify users at increased risk of engaging in behaviour that can be extremely damaging to their finances, health and personal relationships.
With decades of experience in product liability and defective drugs, HSH lawyer Paul Miller is at the forefront of a mass tort litigation against the makers of Abilify. This action aims to help Abilify’s victims receive compensation for its harmful effects and its manufacturer’s role in promoting a drug with known but unacknowledged risks. Unlike a class action lawsuit, this mass tort litigation allows victims to belong to different classes as plaintiffs and cases may proceed individually. The findings and awards for early trials often create paths to settlements in unresolved cases.
Managing a serious medical condition can be challenging enough without the burden of a harmful or counterproductive medication. If you or a loved one has been prescribed Abilify and have experienced harm as a result, HSH can help to explain your rights, options, and whether you may benefit from participating in this mass tort litigation.