Guest guest Posted July 9, 2003 Report Share Posted July 9, 2003 FDATALK PAPER Food and Drug AdministrationU.S. Department of Health and Human ServicesPublic Health Service 5600 Fishers Lane Rockville, MD 20857 FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. T97-23 Ivy Fleischer Kupec: 301-443-3285 June 11, 1997 Broadcast Media: 301-827-3434 Consumer Hotline: 800-532-4440 HEALTH ADVISORY FOR NEWEST CLASS OF AIDS DRUGSFDA today warned physicians that protease inhibitors may contribute to increases in blood sugar and even diabetes in HIV patients and recommended close monitoring of their glucose levels. In a letter to doctors, FDA noted that it had received 83 reported cases of new or exacerbated diabetes mellitus and hyperglycemia (increased blood sugar levels) in HIV-infected patients taking any one of these newest class of AIDS drugs. However, none of this data definitively demonstrates that the drugs caused the condition. While diabetes is a very serious condition, the agency believes these events occur relatively infrequently in patients taking these drugs and does not recommend that patients forego protease inhibitor therapy. Indeed, many patients who developed diabetes while on protease inhibitors were able to control the diabetes through insulin or other more modest agents. Based on present information, the agency continues to believe the benefits of these drugs to patients suffering from HIV infection outweigh the various risks of taking these drugs. Of the 83 patients, 27 were reported to require hospitalization, including six life-threatening cases. Five cases resulted in ketoacidosis, a serious diabetes-related condition that is characterized by a fruity mouth odor, nausea, vomiting, dehydration, weight loss, confusion, and, if untreated, coma or death. All four approved protease inhibitors (saquinavir, indinavir, ritonavir and nelfinavir) will soon carry revised labeling that delineates this potential side effect. While many patients who discontinued protease inhibitor therapy saw a reduction in their symptoms, a clear causal relationship between the drugs and the onset of hyperglycemia or diabetes has not been established. Many of these reports occurred in patients with confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycemia. HIV patients on protease inhibitor therapy should know the warning signs of hyperglycemia and diabetes: increased thirst and hunger, unexplained weight loss, increased urination, fatigue and dry, itchy skin. In the 83 reported cases, these symptoms occurred, on average, in approximately 76 days from starting protease inhibitor therapy, but the agency is aware of cases where symptoms appeared as early as four days after starting this therapy. FDA will continue close monitoring for additional events. The agency encourages all health care professionals to report any cases of diabetes or hyperglycemia, or any other serious toxicity associated with the use of protease inhibitors, to the FDA's MEDWATCH program at 1-800-FDA-1088/fax 1-800-FDA-0178; or to the respective pharmaceutical manufacturers: Crixivan (indinavir), Merck Research Laboratories, 1-800-672-6372Invirase (saquinavir), Hoffman-La Roche, 1-800-526-6367Norvir (ritonavir), Abbott Laboratories, 1-800-633-9110Viracept (nelfinavir), Agouron Pharmaceuticals, 1-888-847-2237 ####karl theis jrvideo field reporterwww.RealityExpander.com Ch.10 TimeWarnerAustin,Texas cell 512 297-9875e-mail: theis888 www.exposureofthetruth.isfamous.com SBC DSL - Now only $29.95 per month! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 10, 2003 Report Share Posted July 10, 2003 Another effect of these drugs is that they tend to redistribute lipids in the body. This is referred to as " protease hump " because it is often distributed to the back giving rise to a hump. >FDA >TALK PAPER > >Food and Drug Administration >U.S. Department of Health and Human Services >Public Health Service 5600 Fishers Lane Rockville, MD 20857 > >FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. > > >T97-23 Ivy Fleischer Kupec: 301-443-3285 >June 11, 1997 Broadcast Media: 301-827-3434 > Consumer Hotline: 800-532-4440 > >HEALTH ADVISORY FOR NEWEST CLASS OF AIDS DRUGS > >FDA today warned physicians that protease inhibitors may contribute to increases in blood sugar and even diabetes in HIV patients and recommended close monitoring of their glucose levels. In a <http://www.fda.gov/cder/proteaseletter.htm>letter to doctors, FDA noted that it had received 83 reported cases of new or exacerbated diabetes mellitus and hyperglycemia (increased blood sugar levels) in HIV-infected patients taking any one of these newest class of AIDS drugs. However, none of this data definitively demonstrates that the drugs caused the condition. [snip] -- Neil Jensen: neil The WWW VL: Sumeria http://www.sumeria.net/ " Dragons is sooooo stupid! " -- Yosemite Sam Quote Link to comment Share on other sites More sharing options...
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