"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
(thiothixene hydrochloride) Concentrate
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Navane (thiothixene hcl) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Navane® (thiothixene) is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-l-piperazinyl)-propylidene] thioxanthene-2-sulfonamide.
The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus.
Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin and titanium dioxide; may contain Yellow 10, Yellow 6, Blue 1, Green 3, Red 3, and other inert ingredients); lactose; magnesium stearate; sodium lauryl sulfate; starch.
Inert ingredients for the oral concentrate formulation are: alcohol; cherry flavor; dextrose; passion fruit flavor; sorbitol solution; water.
What are the possible side effects of thiothixene (Navane)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking thiothixene and call your doctor at once if you have a serious side effect such as:
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
- twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
- tremor (uncontrolled shaking);
- trouble swallowing;
Last reviewed on RxList: 1/14/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Navane Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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