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Mixups with another drug with a similar name, edetate disodium, have led to three deaths, including one autistic child.
The FDA said it is in the process of evaluating the risks and benefits of edetate disodium.
Edetate disodium and edetate calcium disodium work by binding with heavy metals or minerals in the body allowing them to be passed through the urine.
Nonmedicinal ingredients: clove oil, edetate disodium, eucalyptus oil, marjoram oil, menthol crystals, octoxynol, propylene glycol, purified water and synthetic camphor.
In August 2005, an incorrect form of EDTA (edetate disodium) used for chelation therapy resulted in hypocalcemia, causing cardiac arrest that killed a five-year-old autistic boy.
The chelating agents used for treatment of lead poisoning are edetate disodium calcium (CaNaEDTA), dimercaprol (BAL), which are injected, and succimer and d-penicillamine, which are administered orally.
WASHINGTON, Jan. 17 (UPI) -- The U.S. Food and Drug Administration said two drugs with similar names, both containing edetate disodium, might be mistaken for each other.
The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation to include edetate disodium (EDTA).
Edetate disodium was approved as an emergency treatment for certain patients with very high levels of calcium in their blood or certain patients with heart rhythm problems as a result of very high amounts of digitalis in their blood.
The FDA warned healthcare professionals and patients there have been cases in which children and adults have died when mistakenly given edetate disodium instead of edetate calcium disodium, or when edetate disodium was used for chelation therapy and other uses that aren't approved by the FDA.
Because of changes to the European Pharmacopoeia, the medicine has been reformulated and now has 2 additional excipients: edetate disodium dihydrate (EDTA) and citric acid.