Drug Notebook

FDA Alerts

Special Alerts:

[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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics, http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01851.html.

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thiothixene
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(thye oh THICK seen)

What is the most important information I should know about thiothixene?

Thiothixene is not for use in psychotic conditions related to dementia. Thiothixene may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to thiothixene, or if you have a blood cell disorder such as anemia or low white blood cells or platelets, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Call your doctor at once if you have restless muscle movements in your eyes, tongue, jaw, or neck. Thiothixene can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take thiothixene if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Thiothixene can decrease perspiration and you may be more prone to heat stroke.

What is thiothixene?

Thiothixene is an antipsychotic medication. It affects the actions of chemicals in your brain.

Thiothixene is used to treat schizophrenia.

Thiothixene may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking thiothixene?

Thiothixene is not for use in psychotic conditions related to dementia. Thiothixene may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to thiothixene, or if you have:
  • a blood cell disorder such as anemia, low white blood cell counts, or low platelets; or

  • drowsiness, slow breathing, weak pulse, or decreased alertness caused by taking certain medications or drinking alcohol.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using thiothixene, tell your doctor if you have:

Thiothixene may be harmful to an unborn baby. Before taking thiothixene, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether thiothixene passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
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