From: BULLELKMAN@aol.com Sent: Tuesday, July 01, 2003 2:11 AM To: fdadockets@oc.fda.gov Subject: Docket No. 2003N-0169 - Dental Mercury Amalgam Information Dear FDA, As I tell everyone, "how can mercury be a toxin, a poison everywhere but in your mouth?" It is imperative that the new panel review all these studies and start asking lots of tough and honest questions and stop the use of mercury dental fillings. Thank you, Mary Ann Newell Vancouver, WA Toxicity assessment of mercury vapor from dental amalgams. Goering et. al., (1992). Fundam. Appl. Toxicol. 19:319-329. The future of dental amalgam: a review of the literature. Part 6: Posssible harmful effects of mercury from dental amalgam. Eley (1997). Br. Dent. J. 182:455-459. Documented clinical side-effects to dental amalgam. Ziff (1992). Adv. Dent. Res. 6:131-134. Evaluation of the safety issue of mercury release from dental fillings. Lorscheider and Vimy (1993). FASEB J. 7:1432-1433. Mercury neurotoxicity: mechanisms of blood-brain barrier transport. Aschner and Aschner (1990). Neurosci. Biobehav. Rev. 14:169-176. The toxicology of mercury. Clarkson (1997). Crit. Rev. Clin. Lab. Sci. 34:369-403. Cytotoxicity of amalgams, alloys, and their elements and phases. Kaga et. al., (1991). Dent. Mater. 7:68-72. Cytotoxic effects of restorative materials on early passage cultured cells derived from human gingiva. Yamagata and Oshima (1990). Shika Zairyo Kikai 9:541-554. Cytotoxicity of amalgams. Kaga et. al., (1988). J. Dent. Res. 67:1221-1224. Correlation of cytotoxicity with element release from mercury- and gallium-based dental alloys in vitro. Wataha et. al., (1994). Dent. Mater. 10:298-303. . Cytotoxicity of gallium and indium ions compared with mercuric ion. Chandler et. al., (1994). J. Dent. Res. 73:1554-1559. Quantitative evaluation by measuring affected area for cytotoxicity of dental materials. Kaga et al., (1990). Shika Zairyo Kikai 9:591-599. The mechanism of Hg2+ toxicity in cultured human oral fibroblasts: the involvement of cellular thiols. Liu et. al., (1992). Chem. Biol. Interact. 85:69-78. Toxic effects of various retrograde root fillings materials on gingival fibroblasts and rat sarcoma cells. Peltola et. al., (1992). Endod. Dent. Traumatol. 8:120-124. In vitro testing of dental materials by means of macrophage cultures: II. Effects of particulate dental amalgams and their constituent phases on cultured macrophages. Syrjanen et. al., (1986). J. Biomed. Mater. Res. 20:1125-1138. Cytotoxicity of endodontic materials. Osorio et. al., (1998). J. Endod. 24:91-96. Cytotoxicity of retrofill materials. Bruce et. al., (1993). J. Endod. 19:288-292. . Corrosion products from dental alloys and effects of mercuric and cupric ions on a neuroeffector system. Moberg (1985). Swed. Dent. J. Suppl. 29:1-51. Development of low- and high-serum culture conditions for use of human oral fibroblasts in toxicity testing of dental materials. Liu et. al., (1991). J. Dent. Res. 70:1068-1073 A possible case of mercury-related toxicity resulting from the grinding of old amalgam restorations. Taskinen et. al., (1989). Scand. J. Work Environ. Health 15:302-304. Marked elevation of myocardial trace elements in idiopathic dilated cardiomyopathy compared with secondary cardiac dysfunction. Frustaci et al., (1999). J. Am. Coll. Cardiol. 33:1578-83. Intake of Mercury From Fish, Lipid Peroxidation, and the Risk of Myocardial Infarction and Coronary, Cardiovascular, and Any Death in Eastern Finnish Men. Jukka et al., (1995) Circulation. 91:645-655. . Effects of mercury on the isolated heart muscle are prevented by DTT and cysteine. Vassallo et al., (1999). Toxicol. Appl. Pharmacol. 156:113-118. . The chamber exposure of laboratory rats to metal oxides originating from metal producing industry. Kovacikova and Chorvatovicova (1997). Physiol. Res. 46:41-45. . Mercury effects on the contractile activity of isolated heart muscle. Oliveira et al., (1994). Toxicol. Appl. Pharmacol. 128:86-91. . Mercury compounds: lipophilicity and toxic effects on isolated myocardial tissue. Halbach (1990). Arch. Toxicol. 64:315-319. . The relationship between mercury from dental amalgam and the cardiovascular disease. Siblerud (1990). Sci. Total Environ. 99:23-35. . Hemodynamic and electrophysiological effects of mercury in intact anesthetized rabbits and in isolated perfused hearts. Rhee and Choi (1989). Exp. Mol. Pathol. 50:281-290. Cardiovascular homeostasis in rats chronically exposed to mercuric chloride. Carmignani and Boscolo (1984). Arch. Toxicol. Suppl. 7:383-388. . Mechanisms in cardiovascular regulation following chronic exposure of male rats to inorganic mercury. Carmignani et al., (1983). Toxicol. Appl. Pharmacol. 69:442-450.