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Ziprasidone FDA Alerts

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

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 ziprasidone

The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Dronabinol Capsules USP 2.5 mg and Ziprasidone Hydrochloride Capsules 20 mg Due to Label Mix-Up

Jun 13, 2023 | Audience: Consumers

June 13, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level. The Harvard Drug Group, LLC received a customer complaint from a distributor, that some unit dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg for Lot T04769. Accordingly, The Harvard Drug Group, LLC is recalling all of Lot T04769, Dronabinol Capsules, USP, 2.5 mg, which may be in outer cartons that read Dronabinol Capsules, USP, 2.5 mg OR Ziprasidone Hydrochloride Capsules, 20 mg.

Risk Statement: There is a reasonable probability that patients who mistakenly take Dronabinol Capsules, USP, 2.5 mg instead of Ziprasidone Hydrochloride, 20 mg capsules, can experience serious adverse events from 1) missing their ziprasidone dose and 2) taking an unexpected dose of Dronabinol. Patients missing doses of Ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression, or delirium. This can result in mental illness instability with possible consequences of self-harm or harm to others which could result in medical or psychiatric hospitalization. Taking an unexpected dose of Dronabinol may cause mental and cognitive effects that result in impairment of mental and/or physical abilities. This can include worsening of symptoms in patients with mental illness disorders and limitation of patients’ abilities to safely complete hazardous activities (e.g., driving a motor vehicle, operating machinery). Elderly patients or those taking other medications that affect mental function may be particularly at risk for these reactions. The Harvard Drug Group, LLC has not received any reports of adverse events related to this recall.

Ziprasidone Hydrochloride Capsules, 20 mg, is used for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder.

Dronabinol Capsules, USP, 2.5 mg, is used as: (1) an anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS), and (2) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Both Ziprasidone Hydrochloride Capsules, 20 mg and Dronabinol Capsules, USP, 2.5 mg are labeled with lot T04769 EXP. 2024/12 and can be identified on the outer carton labeling as follows:

Product Name

Package Description

Brand Name

Lot
Number

NDC

Expiration Date
Dronabinol
Capsules, USP, 2.5 mg		 100 Unit Doses per
Carton
(10 x 10 blister packs)		 Major T04769 0904-7144-61 2024/12
Ziprasidone
Hydrochloride
Capsules, 20 mg		 40 Unit Doses per
Carton
(10 x 4 blister packs)		 Major T04769 0904-6269-08 2024/12

Ziprasidone Hydrochloride Capsules, 20 mg are capsules with a lavender opaque cap and flesh opaque body, imprinted “RDY’ on the cap and “356” on the body.

Dronabinol Capsules, USP, 2.5 mg are white capsules imprinted with “M2.”

Images of the outer carton labeling of both Ziprasidone Hydrochloride Capsules, 20 mg and Dronabinol Capsules, USP, 2.5 mg and in addition, images of the blister packages of Dronabinol Capsules, USP, 2.5 mg found in cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg, can be found below.

Products were distributed Nationwide to Wholesalers starting April 5, 2023.

The Harvard Drug Group, LLC is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should stop distribution of the product and consumers should stop using this affected product, return it to the place of purchase, and contact their physician or healthcare provider.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-888-759-6904 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug6068@sedgwick.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions

Dec 11, 2014 | Audience: Psychiatry, Dermatology, Pharmacy, Family Practice

ISSUE:  FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). See the FDA Drug Safety Communication for a Data Summary and additional information.

DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. DRESS also causes a higher-than-normal number of a particular type of white blood cell called eosinophils in the blood. DRESS can lead to death.

BACKGROUND: Ziprasidone is an atypical antipsychotic drug used to treat schizophrenia and bipolar I disorder.

FDA reviewed information from six patients in whom the signs and symptoms of DRESS appeared between 11 and 30 days after ziprasidone treatment was started. None of these patients died (see Data Summary in the Drug Safety Communication). Based on this information, FDA required the manufacturer of Geodon to add a new warning for DRESS to the Warnings and Precautions section of the drug labels for the capsule, oral suspension, and injection formulations.

RECOMMENDATION: Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected.

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:


[12/11/2014 - 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]

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