Skip to main content

Aristada FDA Alerts

The FDA Alerts below may be specifically about Aristada or relate to a group or class of drugs which include Aristada.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Aristada

Otsuka Initiates Voluntary Nationwide Recall of Certain Lots of Abilify (aripiprazole) Tablets Due to Drug Product Cross-Contamination on Manufacturing Equipment

Apr 9, 2024 | Audience: Healthcare Provider, Pharmacy, Consumer

PRINCETON, N.J. (April 9, 2024) – Otsuka America Pharmaceutical, Inc. (Otsuka) is voluntarily recalling certain Abilify (aripiprazole) Tablets in the United States due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient manufactured on the same equipment. The Abilify® (aripiprazole) Tablets affected are the 5 mg, 10 mg, 15 mg, and 30 mg doses. The 2 mg and 20 mg doses are not affected. Based on sample testing performed, there is no material patient risk associated with the level of contamination found. The detected amount of the ingredient was confirmed to be extremely small and significantly below the permitted daily exposure (PDE) established by the U.S. Food and Drug Administration (FDA). The voluntary recall has been initiated by Otsuka in the United States out of an abundance of caution, with the knowledge of the U.S. Food and Drug Administration (FDA). This recall is limited to the United States.

The recall will not affect product availability as there are other sources of aripiprazole tablets available in the U.S market for patient use, including 2 mg and 20 mg doses of Abilify® (aripiprazole).

Abilify Maintena® (aripiprazole), Abilify Asimtufii® (aripiprazole) extended-release injectable suspensions, and Abilify MyCite® (aripiprazole tablets with sensor), are not affected by this recall.

There is an ongoing investigation to determine the cause of the cross-contamination and appropriate corrective actions are being put in place to ensure there is not a recurrence. A safety assessment has been conducted and there are no new safety issues identified, and the reported adverse events in the company safety database during the period of January 1, 2021, to March 31, 2024, were consistent with the well-established safety profile of aripiprazole.

Wholesalers that have Abilify Tablets which are being voluntarily recalled, should examine their inventory, cease distributing any impacted product, and return any impacted lots to Otsuka America Pharmaceutical, Inc.

Consumers who have a product that is being recalled and who have concerns, should consult with their healthcare provider or pharmacy. Adverse reactions or quality problems experienced with the use of this product should be reported.

  • Otsuka America Pharmaceutical, Inc. can be reached by phone at 1-833-468-7852 Monday – Friday, 9 a.m. – 5 p.m. Eastern Time, or by email:

  • To report adverse events email: global_intake@otsuka-us.com

  • To report product quality complaints email ProductComplaints@otsuka-us.com.

  • The FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. To complete and submit the report Online: www.fda.gov/medwatch/report.htm.

  • For regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

Source: Otsuka America Pharmaceutical, Inc.

Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems

May 3, 2016 | Audience: Psychiatry, Internal Medicine, Patient

ISSUE: FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized. 

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk FDA identified. In addition, FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

See the FDA Drug Safety Communication for additional information, including a Data Summary. 

BACKGROUND: Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression.  Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder. 

RECOMMENDATION: Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems.  These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors.  Consider reducing the dose or stopping the medicine if such urges develop.

Patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole. It is important to talk with a health care professional as soon as possible if you or a family member experiences any of these uncontrollable urges, in order to prevent or limit possible harm.  Patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional.

See the FDA Drug Safety Communication for additional information for patients, caregivers, and health care professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[05/03/2016 - Drug Safety Communication - FDA]
 

Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns

Feb 22, 2011 | Audience: Psychiatry, OBGYN

Drugs include: Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, Symbyax

ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[02/22/2011 - Drug Safety Communication - FDA]

Antipsychotics, Conventional and Atypical

Jun 16, 2008 | Audience: Neuropsychiatric and geriatrics healthcare professionals[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.

[June 16, 2008 - Information for Healthcare Professionals - FDA]

Atypical Antipsychotic Drugs

Apr 11, 2005 | Audience: Neuropsychiatric healthcare professionals, patients and caregiversThe Food and Drug Administration has issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved, “off-label” use of certain antipsychotic drugs approved for the treatment of schizophrenia and mania. FDA has determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality. Clinical studies of these drugs in this population have shown a higher death rate associated with their use compared to patients receiving a placebo.

[April 11, 2005 - Public Health Advisory - FDA]
[April 11, 2005 - Drug Information Page - FDA]

More Aristada resources