Precautions

According to WebMD, it is important to inform your doctor and pharmacist if you’re allergic to aripiprazole, and if you have other allergies as a precautionary measure. The product contains inactive ingredients (propylene glycol) and can potentially cause allergic reactions and other problems. It’s advised to talk to your provider for further details.

A comprehensive medical history should be provided to the doctor, especially for: diabetes (family history), heart problems (low blood pressure, heart failure, coronary artery disease, irregular heartbeat), blood flow problems in the brain cerebrovascular disease, stroke), problems with the nervous system (dementia, seizures, NMS), low white blood cell count (history of low blood cell count due to the use of medications), swallowing problems, obesity, problems breathing during sleep (sleep apnea).

The drugs is known to cause dizziness, drowsiness and a blurred vision in users. It is recommended to avoid the use of alcohol and marijuana with this drug as it can intensify the symptoms of dizziness and drowsiness. The doctor should be consulted if you are using marijuana and alcohol. Driving, using machinery, performing tasks that require you to be alert and demand a clear vision should be avoided at all costs until the symptoms wear off. 

The use of this medication can make you sweat less, which can increase the chances of a heat stroke. All sorts of activities like exercising in the hot weather, hard work and hot tubs should be avoided that can cause you to overheat. To keep your body temperature optimal, it is recommended to drink lots of fluids. In case of the rise in the body temperature, finding a cool place to rest can help to lower the body temperature and immediately call someone for help just in case. Medical helps should be immediately sought if there mental/mood changes, dizziness, headaches and fever that does not go away.

Older adults are more sensitive to the side effects. Drowsiness, seizures, dizziness, confusion, swallowing problems, lightheadedness, tardive dyskinesia and other side effects may be more serious. Side effects like dizziness, drowsiness, confusion and lightheadedness increases the risk of falling in older adults.

This drug should be avoided during pregnancy and should only be used when clearly needed.  Babies of mothers who use this drug during the last 3 months of their pregnancy may develop symptoms like drowsiness, shakiness, constant crying, muscle stiffness, and feeding or breathing difficulties. If any of these symptoms are noticed in a newborn during the first month, the doctor should be informed immediately.

Breastfeeding is not recommended if this medication is used. The medication is passed into the breastmilk. The doctor should be consulted before breastfeeding.

Liquid preparations of this product might contain sugar, it is recommended to consult your doctor if you have diabete.

Before having surgery the doctor/dentist should be informed about all the products you are using (nonprescription drugs, prescription drugs and, herbal products).

Long-Term Use Considerations

While antipsychotic drugs are commonly used to treat schizophrenia, to relieve the symptoms caused by the disorder. It should be considered how according to a study in 2015, long term use of antipsychotic drugs may negatively impact the brain structure.

The study on Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotics, published in the The New England Journal of Medicine concluded that conventional and atypical antipsychotic medications are likely to increase the death risk among elderly people. It was also founded that the higher risk of mortality in patients with the use of aripiprazole aged from 77-88 years with dementia related psychosis, due to adverse effects on the circulatory system in the brain or cerebrovascular events

Drug Interactions

Can Interact with the Following:

These medications may interact resulting in very harmful effects and should not be taken together, as they may increase the levels and effects of aripiprazole:

• The antiarrhymia agent quinidine
• Antidepressants, such as fluoxetine (Prozac®), paroxetine (Paxil®), and nefazodone
• HIV medications, such as the protease inhibitors indinavir (Crixivan®), ritonavir (Norvir®), saquinavir (Fortovase®, Invirase®), and lopinavir/ritonavir (Kaletra®)
• Antifungals, such as fluconazole (Diflucan®), ketoconazole (Nizoral®), and itraconazole (Sporanox®)
• The antibiotic clarithromycin (Biaxin®)

These medications may decrease the levels and effects of aripiprazole:

• rifampin (Rifadin®)
• carbamazepine (Tegretol®) 

Can’t Interact with the Following:

The doctor or prescriber should be told about all the over the counter, prescription and herbal medication you are taking. If you’re taking any supplements it should be in the doctors or prescribers knowledge. On the basis of the information given, the doctor will adjust your medications accordingly and will manage how drug interactions are being managed or should be managed.

When To Stop Taking

National Alliance on Mental Illness states that disorders like schizophrenia require long-term treatment and an individual should not stop taking aripiprazole, even when feeling better. The length of the aripiprazole treatment can only determined by your healthcare provider.

Doses of aripiprazole should not be missed or changed without the approval of the healthcare provider as it will increase the risk of relapse. For the medication to work properly, it should be taken as instructed by the healthcare provider.

In case if the some of the side effects don’t wear off, medical help should be consulted to get to the root of the problem. If you are planning to conceive, your healthcare provider should be notified to manage your medications.

Long-Term Side Effects

The National Alliance on Mental Illness has stated Tardive Dyskinesia (TD) as a side effect that can be developed due to the prolonged use of antipsychotics. Even though the use of second generation antipsychotics (aripiprazole) has shown a lower risk of TD in comparison to older antipsychotic medication, the risk is still there.

Second generation antipsychotic drugs (SGAs) are linked to the increased risk of diabetes, high cholesterol, high triglycerides and, weight gain as well.

FDA Warnings (History Of)

Food & Drug Administration (U.S) has warned that compulsive and uncontrollable urges to binge eat, have sex, gamble and shop have been reported due to the use of the antipsychotic medication aripiprazole (Abilify). It has also been reported that the urges were stopped with the discontinuation of the medication or the reduction in the dosage. Even though these impulse-control problems are rare, they may be harmful for the patient and others if not recognized on time.

On the basis of FDA Adverse Event Reporting System (FAERS) database and the 13 years of medical literature, since the approval of Abilify in 2002, 184 cases reports have been identified where there is a link between aripiprazole and impulse-control problems. Out of which 167 were U.S cases, including adults and children. Out of which 164 cases had pathological gambling as the most common side effect. However, other compulsive behaviours like shopping, binge eating and, sexual behavior were reported as well. FAERS only has the reports about the cases which are submitted to the FDA, there might be cases which the FDA is unaware of. Therefore, to provide context to these drug associated events, in 2015 aripiprazole was prescribed to 1.6 million patients in the U.S from outpatient retail pharmacies.

In most of the cases, its identified that patients who had no history of compulsive behavior experienced impulse-control problems after beginning the aripiprazole treatment. Reducing the dosage or discontinuing aripiprazole stopped the uncontrollable urges in a matter of days or weeks.

Other Common Side Effects

According to Health Line, there can be mild side effects because of the aripiprazole oral tablet. Here are some of the common side effects that may occur:

• Drowsiness
• Vomiting
• Nausea
• Dizziness
• Anxiety
• Constipation
• Agitation
• Tiredness
• Stuffy nose
• Headaches
• Restlessness 
• Increased appetite
• Trouble sleeping
• Muscle stiffness
• Mood fluctuations

These side effects may go away with a couple of days or weeks, in case if these side effects don’t go away the healthcare provider or pharmacist should be consulted.

Some of the serious side effects on Health Line are noted as:

• NMS (Neuroleptic Malignant Syndrome). Symptoms:
  • Confusion
  • Sweating
  • Fever
  • Changes in blood pressure or heart rate
  • Muscle stiffness
• Tardive Dyskinesia. Symptoms:
  • Losing the ability to control your tongue, face or other body parts.
• Orthostatic Hypotension (it is when low blood pressure occurs when you a person gets up quickly after lying or sitting down). Symptoms include:
  • Dizziness
  • Feeling lightheaded
  • Fainting
• Stroke. Symptoms include:
  • Confusion
  • Weakness or numbness in one side of the body
  • Slurred speech
• Seizures
• Low white blood cell count
• Gambling or other uncontrollable impulses.
• Weight gain
• Trouble Swallowing
• High blood sugar

If a person has serious side effects and feel life threatening the doctor should be called right away.

Lawsuits

According to The Justice Lawyer, abilify users have alleged that taking this antipsychotic drug has caused them to develop compulsive behaviours such as: binge eating, pathological gambling and hypersexuality. A link between the drug and compulsive behavior was confirmed after dozens of reports and studies. Hundreds of people have filed lawsuits against over claims that the drug makers Otsuka Pharmaceuticals and Bristol-Myers Squibb were aware of the side effects and didn’t warn the consumers.

Experts have known about the risks since the mid-2000s. When studies and reports between unexpected behavior started to rise, the regulators took an action. The European Medicines Agency required abilify to include a warning label for pathological gambling as a side effect in 2012. In 2016, FDA finally issued a safety announcement warning compulsive behavior or uncontrollable urges to binge eat, shop, have sex and gamble is a side effect of the antipsychotic drug. In August, 2016 the warning of compulsive behavior was finally added to the label.

Even though FDA, updated the labels in 2016, many users were unaware. Therefore, patients started to file lawsuits against Otsuka and Bristol-Myers Squibb where they were accused of designing a defective drug and hiding the side effects from the public. Plaintiff Joseph and Meredith Edgar filed a lawsuit against the manufacturer for the failure to warn about the risks and designing a drug which was defective. In 2009, Joseph was prescribed abilify and started to compulsively gamble, he lost more than $36,000 and also suffered other physical, mental and economic loses. His case wasn’t the only one with such complaints.Litigation related to Abilify is still going on, by 2018 there were more than 700 cases pending. The first cases are headed to trial in June 2018.

Tracy Everhart

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.