Rochester, New York (NewYorkInjuryNew.com) — Letters were recently issued to manufacturers of antipsychotic drugs that are categorized as “conventional” in an effort to make the language on all antipsychotic drug warnings uniform. The United States Food and Drug Administration (FDA) issued the new requirements under the 2007 FDA Amendments Act.
Labeling on these drugs are now required to include warnings related to death risks associated with drugs used in the treatment of behavioral problems in older individuals who have dementia. The efforts are meant to ensure that the most up to date safety information is provided to health care professionals who administer these drugs as well as consumers. Manufacturers are required to make the drug labeling changes, and submit them to the FDA within a 30 day time frame. They may also choose to submit reasons they feel modifications are not needed, if they believe their labels already meet the requirements. Not submitting changes or notification could warrant compliance action by the FDA.
There are two main classifications for antipsychotic drugs” conventional and atypical. The term conventional is used to categorize older medications and atypical is used for newer ones. Both are stated to have similar uses; however they can carry different side effects. Antipsychotic drugs are not approved by the FDA to treat symptoms of dementia. Physicians use their professional judgment to decide whether to administer these drugs when treating psychotic disorders like schizophrenia in patients who show dementia symptoms.
Disclaimer: Those taking conventional or atypical antipsychotic drugs are strongly advised to not discontinue use abruptly. One should consult their health care provider before stopping these types of medications. The FDA lists additional information on their website http://www.fda.gov for healthcare professionals and consumers about both categories of antipsychotic drugs.
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