Food and Drug Administration warnings

United States Food and Drug Administration. Warning against misusing of Fentanyl Analgesic Skin Patch. Accessed 17 July 2002. 

Ttamin D toxicity may arise from well-meaning, but needless, administration by parents. The US Food and Drug Administration warns that intake of fortified diet supplements should not exceed 400 Emits a day. 

Olfson M. Marcus SC. Druss BG. Effects of Food and Drug Administration warnings on antidepressant use in a national sample. Arch Gen Psychiatry 2008 65(l) 94-101. 

The U.S. Food and Drug Administration warns of possibie increase in anticoaguiant effects of warfarin with concomitant use. 

State Food and Drug Administration. Warnings on serious allergic reaction caused by Xinxinnao injection. Chin Adv Drug React Inf Bull 2011 38. 

FDA Safety Alert Hazards of Precipitation Associated With Parenteral Nutrition The Food and Drug Administration warned against the risk of precipitations in parenteral nutrition mixtures in 1994 [55]. This warning occurred after two deaths and at least two patients with dyspnoea after infusion of all-in-one nutrition admixmres. The FDA suspected that these admixtures contained calcium phosphate precipitates. 

Approximately 10% of new chemical entities (NCEs) show serious adverse drug reactions (ADRs) after market launch. Such events usually result in new black box warnings by the US Food and Drug Administration (FDA), label change or market withdrawal. The most common causes for these actions are hepatic toxicity, hematologic toxicity and cardiovascular toxicity [2], Reasons for such ADRs, which are identified only after NCEs are launched on the market, include the narrow spectrum of clinical disorders and participating patient profiles in clinical studies as well as the fact that serious ADRs are often rare and that the number of patient exposures required to identify such occurrences sometimes may range over a few millions [3],... 

Theodore Klumpp, the Food and Drug Administration s chief medical officer, who interviewed Watkins soon after disaster struck, expressed amazement at the chemist s "revelation of ignorance" (22). For anyone alert to the literature, warning signs abounded. 

Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box. The boxed warning ordinarily shall be based on clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. 

In 1977, The Food and Drug Administration initiated a warning label policy in light of inconclnsive evidence that the sweetener might cause cancer in high doses. Their increased application in food and drink products has given a new impetus to develop fast and accmate methods for their determination. 

There are some other acute toxicity tests in which non-lethal outcome are sought. These include studies of the amount of chemical needed to cause skin or eye irritation or more serious damage. Test systems developed by J. H. Draize and his associates at the Food and Drug Administration in the early 1940s were used to study ocular effects. Warning labels on consumer products were typically based on the outcome of the Draize test. 

Food and Drugs Administration (FDA). (2006). FDA warns consumers not to drink bolthouse farms carrot juice due to botulism concerns, http //www.cfsan.fda.gov/ lrd/fpcarro2. htmlAccessed Dec. 08. 

Galantamine is used for the treatment of mild to moderate Alzheimer s disease. However in 2005 the U.S. Food and Drug Administration sent out a warning indicating that the product should not be used in patients with mild cognitive impairment (MCI) because of increased mortality observed in trials for MCI with galantamine. Galantamine is a competitive and reversible cholinesterase inhibitor. 

Clark, F., and D. R. Reed. Chaparral-induced toxic hepatitis. California and Texas, 1992. MMWR Morbid Mortal Wkly Rep 1992 41(43) 812-814. Anon. From the Food and Drug Administration. Public Warning about herbal product Chaparral . J Amer Med Ass 1993 269(3) 328. 

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