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- Boxed_warning abstract "In the United States, a boxed warning (sometimes called a black box warning, colloquially) is a type of alert that appears on the package insert for certain prescription drugs. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued. For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people were given the drug. Later research indicated that after receiving an FDA advisory, there was a decrease in rosiglitazone use, due to a combined effect of media exposure, advisory, and scientific publications, whereas pioglitazone (with a similar advisory) did not similarly decrease in use. This challenges the idea that physicians and patients will have a conversation after a boxed warning is issued. Throughout the country, boxed warnings will be translated into prescription patterns differently by different physicians. In 2005, the FDA issued a boxed warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia. This advisory was associated with a decrease in use of antipsychotics, especially in elderly patients with dementia.".
- Boxed_warning wikiPageExternalLink blackboxrx.com.
- Boxed_warning wikiPageID "2105763".
- Boxed_warning wikiPageRevisionID "601506889".
- Boxed_warning hasPhotoCollection Boxed_warning.
- Boxed_warning subject Category:Food_and_Drug_Administration.
- Boxed_warning subject Category:Hazards.
- Boxed_warning subject Category:Pharmaceutical_industry.
- Boxed_warning type CausalAgent100007347.
- Boxed_warning type Danger114541044.
- Boxed_warning type Hazard114541852.
- Boxed_warning type Hazards.
- Boxed_warning type PhysicalEntity100001930.
- Boxed_warning comment "In the United States, a boxed warning (sometimes called a black box warning, colloquially) is a type of alert that appears on the package insert for certain prescription drugs. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it.".
- Boxed_warning label "Black-Box-Warnung".
- Boxed_warning label "Boxed warning".
- Boxed_warning sameAs Black-Box-Warnung.
- Boxed_warning sameAs m.06mgqq.
- Boxed_warning sameAs Q879952.
- Boxed_warning sameAs Q879952.
- Boxed_warning sameAs Boxed_warning.
- Boxed_warning wasDerivedFrom Boxed_warning?oldid=601506889.
- Boxed_warning isPrimaryTopicOf Boxed_warning.