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Its efficacy as an antimicrobial agent, the risk of antimicrobial resistance, and its possible role in disrupted hormonal development remains controversial. Additional research seeks to understand its potential effects on organisms and environmental health. Triclosan was developed in 1966. [1]
FDA-labelled indication? TGA-labelled indication? MHRA-labelled indication? Literature support Acute infective exacerbation of COPD: Yes: No: No: Clinical trials are lacking. Prophylaxis in HIV-infected individuals: No: No: No: Effective in one Ugandan study on morbidity, mortality, CD4-cell count, and viral load in HIV infection. [31] Otitis media
In a 1998 study using the FDA protocol, a non-alcohol sanitizer with benzalkonium chloride as the active ingredient met the FDA performance standards, while Purell, a popular alcohol-based sanitizer, did not. The study, which was undertaken and reported by a leading US developer, manufacturer and marketer of topical antimicrobial ...
The FDA also said that using unapproved animal drugs in humans could delay effective treatment and allow infections to become severe and resistant to antibiotics and anti-fungal drugs.
The U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
The FDA stated "There is no data demonstrating that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water". [6] The agency also asserted that despite requests for such information, the FDA did not receive sufficient data from manufacturers on the long-term health effects of these chemicals.
The Food and Drug Administration began to review the safety of triclocarban and triclosan in the 1970s, but due to the difficulties of finding antimicrobial alternatives, no final policy, or "drug monograph," was established. [20] Legal action by the Natural Resources Defense Council in 2010 forced the FDA to review triclocarban and triclosan. [20]
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...