The prescription drug Geodon, also sold as a generic under the name Ziprasidone, was manufactured by Pfizer to treat schizophrenia and the maniac symptoms associated with bipolar disorder. The drug works by making changes to the effects of chemicals in the brain. The drug was prescribed to both adults and children ages 10 and older.
Notification of Geodon Side Effects
On August 31, 2004, both the FDA and Pfizer began notifying doctors about some serious Geodon side effects that had been found. These side effects included high blood sugar and the risk of developing diabetes. The FDA also asked Pfizer to include a warning to patients on the label of Geodon about the risk of developing high blood sugar and diabetes.
What Risks were Shown in Studies?
One study that was done showed that atypical antipsychotic medications, which is the class Geodon is in, caused diabetes in more cases than the older class of antipsychotics by at least 50%. Atypical antipsychotic medications include Geodon, Risperdal, Zyprexa, Seroquel, Abilify and Clozaril.
What are the More Serious Geodon Side Effects?
In addition to the diabetes risk, there is a concern that Geodon and other similar drugs could increase the possibility of a fatal heart rhythm irregularity known as torsade de pointes. In 1998, Ziprasidone was not approved for sale by the FDA because of evidence it caused the QT interval of the heart to lengthen. The change is associated with torsade. The QT interval is the measure of time from the start of the Q wave and the end of the T wave in the heart’s electrical cycle.
In 2014, the FDA issued another warning regarding a serious, possible fatal, skin reaction for Geodon and its generic. The skin reaction can spread to other parts of the body. The warning was placed on the drug’s label as Drug Reaction with Eosinophilia and Systemic Symptoms, abbreviated as DRESS.
The skin reaction begins as a rash that spread all over the body. Symptoms include:
- Swelling of the Lymph Nodes
- Inflammation of the Liver, Kidney, Lungs, Heart or Pancreas
FDA Issues Black Box Warning
The FDA issued a black box warning for Geodon side effects in 2005 due to risks of giving the medication to elderly patients with dementia. It had also been linked to with the conditions Tardive Dyskinesia and Neuroleptic Malignant Syndrome.
The Symptoms of Tardive Dyskinesia
Some of the more serious Geodon side effects include an increased risk of death in elderly patients, but also to the development of Tardive Dyskinesia (TD). TD is a potentially permanent neurological disorder. It is associated with uncontrollable body or facial movements, such as:
Shrugging of the Shoulders
Irregular Finger Movements
The Symptoms of Neuroleptic Malignant Syndrome
This syndrome is a reaction to medication that is potentially fatal, but it is a rare condition. The symptoms include:
Defects of Autonomic Functions, such as: excessive sweating, wide swings in blood pressure, excessive saliva
Additionally, Geodon is known for these side effects:
Abnormal Muscle Movements, such as tremors, shuffling and uncontrollable movements
FDA Warns Pfizer About Geodon Failures
The FDA had issued Pfizer a warning about the number of “failures” that occurred during the clinical trials for Geodon that resulted in the overdose of 13 children. In the agency’s letter, it claimed that Pfizer “failed to ensure proper monitoring” during the clinical trial and it was noted that some children suffered restless legs, tremors and some other complications when they took Geodon.
Due to the monitoring issues, it was claimed that test subjects in the pediatric clinical trials had overdosed at many of the study sites and because of the lax monitoring, the overdosing was not detected and corrected in a timely manner. It was also reported by the media that Pfizer had paid doctors and hospitals a total of $35 million to promote Pfizer’s drugs.
How Much did Pfizer Pay in Fines?
The drug company also was forced to pay $2.3 billion to settle claims against them that they illegally marketed their drugs, including Geodon. Among the charges that were filed against them by the U.S. Department of Justice was that they paid kickbacks to healthcare providers to prescribe Geodon and other drugs made by Pfizer.
Contacting a Lawyer
If you have been taking Geodon for a psychotic disorder and have experienced any of the symptoms, contact your doctor immediately. If you doctor diagnoses you with any of the conditions connected to Geodon, you should contact a civil litigation attorney to discuss any possible case against Pfizer. You could recover money to pay for your treatment for any conditions you have because of using Geodon, especially if your doctor can make the link between your condition and the known Geodon side effects.