FDA Approves Geodon to Help Treat Adult Bipolar Disorder
The Food and Drug Administration has announced it has approved the Pfizer manufactured drug Geodon Capsules (ziprasidone HCl) for the adjunctive treatment of bipolar I disorder in adults. The approval is based on clinical data which demonstrates Geodon is well tolerated in patients as an adjunct to lithium or valproate. The long term treatment of patients with bipolar disorder requires antipsychotics to help manage mood episodes, which can have a devastating effect on patients’ lives, as well as those around them.
The data for Geodon shows that intervention was required in nearly 20 percent of patients who suffered a mood episode and were given the drug for six months compared to over 32 percent who were given a placebo.
Geodon was approved by the FDA in 2001 to treat acute manic and mixed episodes due to bipolar disorder, as well as for treatment of schizophrenia.
Adverse Side Effects
Side effects associated with Geodon are most commonly dizziness, abnormal vision, somnolence, extrapyramidal symptoms, and akathisia. Geodon is not approved for treating the elderly for dementia due to an increased risk of death. Patients who are known to have heart problem or be at a greater risk of heart failure should also not be given this medication.
Neruoleptic malignant syndrome (NMS) has been associated with all antipsychotics including Geodon. This rare condition may cause:
- Muscle rigidity
- Irregular pulse or blood pressure
- Cardiac dysrhythmia
- Altered mental status
Other serious conditions that may occur with taking Geodon include tardive dyskinesia, serious hyperglycemic events, and respiratory tract infections. The risk of rash, orthostatic hypotension, and seizures is also present.
If you or a loved one has been injured by taking Geodon, please contact the experienced drug injury lawyers at Schlichter, Bogard & Denton for an initial case consultation. We serve clients in Kansas City, Missouri, as well as nationwide.