NTP-CERHR expert panel report on the reproductive and developmental toxicity of methylphenidate

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 74, Issue 4, 2005, Pages 300-381

  Golub, Mari ^a   Costa, Lucio ^b   Crofton, Kevin ^c   Frank, Deborah ^d   Fried, Peter ^e   Gladen, Beth ^f   Henderson, Rogene ^g   Liebelt, Erica ^h   Lusskin, Shari ⁱ   Marty, Sue ^j   Rowland, Andrew ^k   Scialli, John ^l   Vore, Mary ^m   Shelby, Michael D ^f  

^a CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^d BOSTON MEDICAL CENTER   (United States)

^e CARLETON UNIVERSITY   (Canada)

^f NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

^g LOVELACE RESPIRATORY RESEARCH INSTITUTE   (United States)

^h UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

ⁱ NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j DOW CHEMICAL COMPANY   (United States)

^k UNIVERSITY OF NEW MEXICO   (United States)

^l University of Kentucky ^*

^m UNIVERSITY OF KENTUCKY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ASPARTAME; CELLULOSE; CELLULOSE ACETATE; CETOSTEARYLIC ALCOHOL; COPOLYMER; DEXMETHYLPHENIDATE; ETHYL CELLULOSE; GUM TRAGACANTH; HEXADECANOL; HYDROXYPROPYLMETHYLCELLULOSE; IRON OXIDE; LACTOSE; MACROGOL; MAGNESIUM STEARATE; MALTOSE; METHACRYLIC ACID; METHYLIN ER; METHYLPHENIDATE; MICROCRYSTALLINE CELLULOSE; MINERAL OIL; PHOSPHORIC ACID; POLOXAMER; POVIDONE; SODIUM CHLORIDE; STARCH; STEARIC ACID; SUCCINIC ACID; TALC; TITANIUM DIOXIDE; TRIACETIN; UNINDEXED DRUG; ZEIN;

ABDOMINAL PAIN; ANOREXIA; ANXIETY DISORDER; APPETITE DISORDER; ATTENTION DEFICIT DISORDER; CHILD DEVELOPMENT; CLINICAL TRIAL; COGNITIVE DEFECT; COUGHING; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG EFFECT; DRUG FORMULATION; DRUG METABOLISM; DRUG STRUCTURE; ECZEMA; EPISTAXIS; FLU LIKE SYNDROME; FOOD AND DRUG ADMINISTRATION; GASTROENTERITIS; HEADACHE; HERPES SIMPLEX; HUMAN; INJURY; INSOMNIA; KETOACIDOSIS; MENTAL INSTABILITY; MYALGIA; NARCOLEPSY; NAUSEA; NERVOUSNESS; NEUROTOXICITY; NONHUMAN; OCCUPATIONAL EXPOSURE; OTALGIA; PERSONALITY DISORDER; PHARMACODYNAMICS; PHARYNGITIS; PRENATAL DRUG EXPOSURE; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; REVIEW; RHINITIS; SIDE EFFECT; SOMNOLENCE; TACHYCARDIA; THORAX PAIN; TREATMENT OUTCOME; VIRUS INFECTION; VOMITING; WEIGHT REDUCTION;

HERPES;

EID: 24644453573     PISSN: 15429733     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdrb.20049     Document Type: Review

References (171)

1. AAP. 1987. American Academy of Pediatrics Committee on Children with Disabilities, Committee on Drugs: medication for children with an attention deficit disorder. Pediatrics 80:758-760.
2. AAP. 2001. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics 108:1033-1044.
3. Aarskog D, Ferang F, Klove H, Stoa KF, Thorsen T. 1977. Effect of the stimulant drugs, dextroamphetamine and methylphenidate on secretion of growth hormone in hyperactive children. J Pediatr 90:136-139.
4. Ahmann PA, Waltonen SJ, Olson KA, Theye FW, Van Erem AJ, LaPlant RJ. 1993. Placebo-controlled evaluation of Ritalin side effects. Pediatrics 91:1101-1106.
5. ALZA. 2003. Concerta® extended-release tablets product labeling. Mountain View, CA: ALZA Corporation.
6. Aman MG, Werry J. 1975. Methylphenidate in children: effects upon cardiorespiratory function on exertion. Int J Ment Health 4:119-131.
7. Aoyama T, Kotaki H, Sasaki T, Sawada Y, Honda Y, Iga T. 1993. Nonlinear pharmacokinetics of threo-methylphenidate enantiomers in a patient with narcolepsy and in healthy volunteers. Fur J Clin Pharmacol 44:79-84.
8. Bakhtiar R, Tse FL. 2004. Toxicokinetic assessment of methylphenidate (Ritalin®) enantiomers in pregnant rats and rabbits. Biomed Chromatogr 18:275-281.
9. Ballard JE, Boileau RA, Sleator EK, Massey BH, Sprague RL. 1976. Cardiovascular responses of hyperactive children to methylphenidate. J Am Med Assoc 236:2870-2874.
10. Barkley RA, Fischer M, Smallish L, Fletcher K. 2003. Does the treatment of attention-deficit/hyperactivity disorder with stimulants contribute to drug use/abuse? A 13-year prospective study. Pediatrics 111:97-109.
11. Barkley RA, McMurray MB, Edelbrock CS, Robbins K. 1990. Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation. Pediatrics 86:184-192.
12. Beck L, Langford WS, MacKay M, Sum G. 1975. Childhood chemotherapy and later drug abuse and growth curve: follow-up study of 30 adolescents. Am J Psychiatry 132:436-438.
13. Biederman J, Wilens T, Mick E, Spencer T, Faraone SV. 1999. Pharmacotherapy of attention-deficit/hyperactivity disorder reduces risk for substance use disorder. Pediatrics 104:e20.
14. Bloom AS, Russell LJ, Weisskopf B, Blackerby JL. 1988. Methylphenidate-induced delusional disorder in a child with attention deficit disorder with hyperactivity. J Am Acad Child Adolesc Psychiatry 27:88-89.
15. Bolanos CA, Barrot M, Berton O, Wallace-Black D, Nestler EJ. 2003. Methylphenidate treatment during pre- and peri adolescence alters behavioral responses to emotional stimuli at adulthood. Biol Psychiatry 54:1317-1329.
16. Borcherding BG, Keysor CS, Rapoport JL, Elia J, Amass J. 1990. Motor/vocal tics and compulsive behaviors on stimulant drugs: is there a common vulnerability? Psychiatry Res 33:83-94.
17. Brandon CL, Marinelli M, Baker LK, White FJ. 2001. Enhanced reactivity and vulnerability to cocaine following methylphenidate treatment in adolescent rats. Neuropsychopharmacology 25:651-661.
18. Brandon CL, Marinelli M, White FJ. 2003. Adolescent exposure to methylphenidate alters the activity of rat midbrain dopamine neurons. Biol Psychiatry 54:1338-1344.
19. Brown RT, Sexson SB. 1989. Effects of methylphenidate on cardiovascular responses in attention deficit hyperactivity disordered adolescents. J Adolesc Health Care 10:179-183.
20. Brown RT, Wynne ME, Slimmer LW. 1984. Attention deficit disorder and the effect of methylphenidate on attention, behavioral, and cardiovascular functioning. J Clin Psychiatry 45:473-476.
21. Brown WA, Williams BW. 1976. Methylphenidate increases serum growth hormone concentrations. J Clin Endocrinol Metab 43: 937-939.
22. Carlezon WA Jr, Mague SD, Andersen SL. 2003. Enduring behavioral effects of early exposure to methylphenidate in rats. Biol Psychiatry 54:1330-1337.
23. Castellanos FX, Giedd JN, Elia J, Marsh WL, Ritchie GF, Hamburger SD, Rapoport JL. 1997. Controlled stimulant treatment of ADHD and comorbid Tourette's syndrome: effects of stimulant and dose. J Am Acad Child Adolesc Psychiatry 36:589-596.
24. Celltech. 2002. Metadate® ER tablets product labeling. Rochester, NY: Celltech Pharmaceuticals, Inc.
25. Celltech. 2003. Metadate® CD product labeling. Rochester, NY: Celltech Pharmaceuticals, Inc.
26. Chan YPM, Swanson JM, Soldin SS, Thiessen JJ, Macleod SM, Logan W. 1983. Methylphenidate hydrochloride given with or before breakfast. Part 2. Effects on plasma concentration of methylphenidate and ritalinic acid. Pediatrics 72:56-59.
27. Chapin RE, Gulati DK, Fail PA, Hope E, Russell SR, Heindel JJ, George JD, Grizzle TB, Teague JL. 1993. The effects of feed restriction on reproductive function in Swiss CD-1 mice. Fundam Appl Toxicol 20:15-22.
28. ChemIDplus. 2004. Methylphenidate. Available at http://chem2.sis.nlm. nih.gov/chemidplus/ProxyServlet?objectHandle=DBMaint&action Handle=default&nextPage=jsp/chemidlite/ResultScreen.jsp& TXTSUPERLISTID=000113451. National Library of Medicine.
29. Cherland E, Fitzpatrick R. 1999. Psychotic side effects of psychostimulants: a 5-year review. Can J Psychiatry 44:811-813.
30. Chilcoat HD, Breslau N. 1999. Pathways from ADHD to early drug use. J Am Acad Child Adolesc Psychiatry 38:1347-1354.
31. Coffey B, Shader RI, Greenblatt DJ. 1983. Pharmacokinetics of benzodiazepines and psychostimulants in children. J Clin Psychopharmacol 3:217-225.
32. Conners CK, Taylor E. 1980. Pemoline, methylphenidate, and placebo in children with minimal brain dysfunction. Arch Gen Psychiatry 37:922-930.
33. Connor DE 2002. Preschool attention deficit hyperactivity disorder: a review of prevalence, diagnosis, neurobiology, and stimulant treatment. J Dev Behav Pediatr 23:S1-S9.
34. Davids E, Zhang K, Tarazi FI, Baldessarini RJ. 2002. Stereoselective effects of methylphenidate on motor hyperactivity in juvenile rats induced by neonatal 6-hydroxydopamine lesioning. Psychopharmacology (Berl) 160:92-98.
35. Debooy VD, Seshia MM, Tenenbein M, Casiro OG. 1993. Intravenous pentazocine and methylphenidate abuse during pregnancy. Maternal lifestyle and infant outcome. Am J Dis Child 147:1062-1065.
36. Denckla MB, Bemporad JR, MacKay MC. 1976. Tics following methylphenidate administration. A report of 20 cases. JAMA 235:1349-1351.
37. Dunnick JK, Hailey JR. 1995. Experimental studies on the long-term effects of methylphenidate hydrochloride. Toxicology 103:77-84.
38. Efron D, Jarman F, Barker M. 1997. Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. Pediatrics 100:662-666.
39. Ennvironmental Health Research and Testing. 1984. SMVCE-Methylphenidate HCl. Cincinnati, OH. Report nr N01-ES-3-5026.
40. Erenberg G, Cruse RP, Rothner AD. 1985. Gilles de la Tourette's syndrome: effects of stimulant drugs. Neurology 35:1346-1348.
41. FDA. 2001a. Focalin: chemistry review(s), clinical pharmacology and biopharmaceutics reviews(s), and medical review. Center for Drug Evaluation and Research. Report nr 21-278.
42. FDA. 2001b. Ritalin LA: clinical pharmacology and biopharmaceutics reviews(s), medical review, and statistical review. Center for Drug Evaluation and Research. Report nr 21-284.
43. FDA. 2004. Electronic orange book: approved drug products with therapeutic equivalence evaluations. Available at http://www.fda. gov/cder/ob/default.htm. Food and Drug Administration Center for Drug Evaluation and Research.
44. Fine S, Johnston C. 1993. Drug and placebo side effects in methylphenidate-placebo trial for attention deficit hyperactivity disorder. Child Psychiatry Hum Dev 24:25-30.
45. Fischer M, Barkley RA. 2003. Childhood stimulant treatment and risk for later substance abuse. J Clin Psychiatry 64 Suppl 11:19-23.
46. Foley R, Mrvos R, Krenzelok EP. 2000. A profile of methylphenidate exposures. J Toxicol Clin Toxicol 38:625-630.
47. Fras I, Karlavage J. 1977. The use of methylphenidate and imipramine in Gilles de la Tourette's disease in children. Am J Psychiatry 134:195-197.
48. Fukui R, Svenningsson P, Matsuishi T, Higashi H, Nairn AC, Greengard P, Nishi A. 2003. Effect of methylphenidate on dopamine/DARPP signalling in adult, but not young, mice. J Neurochem 87:1391-1401.
49. Gadow KD. 1999. Methylphenidate treatment of ADHD in children with Tourette Syndrome. Crisp Data Base National Institutes of Health.
50. Gadow KD, Nolan E, Sprafkin J, Sverd J. 1995a. School observations of children with attention-deficit hyperactivity disorder and comorbid tic disorder: effects of methylphenidate treatment. J Dev Behav Pediatr 16:167-176.
51. Gadow KD, Sverd J, Sprafkin J, Nolan EE, Ezor SN. 1995b. Efficacy of methylphenidate for attention-deficit hyperactivity disorder in children with tic disorder. Arch Gen Psychiatry 52:444-455.
52. Golden GS. 1974. Gilles de la Tourette's syndrome following methylphenidate administration. Dev Med Child Neurol 16:76-78.
53. Golden GS. 1977. The effect of central nervous system stimulants on Tourette syndrome. Ann Neurol 2:69-70.
54. Greeley GH Jr, Kizer JS. 1980. The effects of chronic methylphenidate treatment on growth and endocrine function in the developing rat. J Pharmacol Exp Ther 215:545-551.
55. Greenberg LM, Yellin AM. 1975. Blood pressure and pulse changes in hyperactive children treated with imipramine and methylphenidate. Am J Psychiatry 132:1325-1326.
56. Greenhill LL. 1992. Pharmacologic treatment of attention deficit hyperactivity disorder. Psychiatr Clin North Am 15:1-27.
57. Greenhill LL, Halperin JM, Abikoff H. 1999. Stimulant medications. J Am Acad Child Adolesc Psychiatry 38:503-512.
58. Greenhill LL, Perel JM, Rudolph G, Feldman B, Curran S, Puig-Antich J, Gardner R. 2001. Correlations between motor persistence and plasma levels in methylphenidate-treated boys with ADHD. Int J Neuropsychopharmacol 4:207-215.
59. Greenhill LL, Puig-Antich J, Novacenko H, Solomon M, Anghern C, Florea J, Goetz R, Fiscina B, Sachar EJ. 1984. Prolactin, growth hormone and growth responses in boys with attention deficit disorder and hyperactivity treated with methylphenidate. J Am Acad Child Psychiatry 23:58-67.
60. Gross MD. 1976. Growth of hyperkinetic children taking methylphenidate, dextroamphetamine, or imipramine/desipramine. Pediatrics 58:423-431.
61. Gross-Tsur V, Manor O, van der Meere J, Joseph A, Shalev RS. 1997. Epilepsy and attention deficit hyperactivity disorder: is methylphenidate safe and effective? J Pediatr 130:670-674.
62. Gunby P. 1979. Methylphenidate abuse produces retinopathy. JAMA 241:546.
63. Handen BL, Feldman H, Gosling A, Breaux AM, McAuliffe S. 1991. Adverse side effects of methylphenidate among mentally retarded children with ADHD. J Am Acad Child Adolesc Psychiatry 30: 241-245.
64. Heinonen OP. 1977. Birth defects and drugs in pregnancy. Littleton, MA: Publishing Sciences Group Inc.
65. Hemmer SA, Pasternak JF, Zecker SG, Trommer BL. 2001. Stimulant therapy and seizure risk in children with ADHD. Pediatr Neurol 24:99-102.
66. HSDB. 2002. Methylphenidate. Available at http://toxnet.nlm.nih.gov/cgi- bin/sis/search/f?./temp/~PMHaIx:1. National Library of Medicine.
67. Hubbard JW, Srinivas NR, Quinn D, Midha KK. 1989. Enantioselective aspects of the disposition of dl-threo-methylphenidate after the administration of a sustained-release formulation to children with attention deficit-hyperactivity disorder. J Pharmacol Sci 78:944-947.
68. Hungund BL, Perel JM, Hurwic MJ, Sverd J, Winsberg BG. 1979. Pharmacokinetics of methylphenidate in hyperkinetic children. Br J Clin Pharmacol 8:571-576.
69. Hunt RD, Cohen DJ, Anderson G, Clark L. 1984. Possible change in noradrenergic receptor sensitivity following methylphenidate treatment: growth hormone and MHPG response to clonidine challenge in children with attention deficit disorder and hyperactivity. Life Sci 35:885-897.
70. Johnston LD, O'Malley PM, Bachman JG, Schulenberg JE. 2003. Monitoring the future-national survey results on drug use, 1975-2003: Volume I, Secondary school students. Bethesda, MD: National Institute on Drug Abuse. Report nr NIH Publication No. 04-5507.
71. Kalachnik JE, Sprague RL, Sleator EK, Cohen MN, Ullmann RK. 1982. Effect of methylphenidate hydrochloride on stature of hyperactive children. Dev Med Child Neurol 24:586-595.
72. Kelly KL, Rapport MD, DuPaul GJ. 1988. Attention deficit disorder and methylphenidate: a multi-step analysis of dose-response effects on children's cardiovascular functioning. Int Clin Psychopharmacol 3: 167-181.
73. Kent JD, Blader JC, Koplewicz HS, Abikoff H, Foley CA. 1995. Effects of late-afternoon methylphenidate administration on behavior and sleep in attention-deficit hyperactivity disorder. Pediatrics 96: 320-325.
74. Kimko HC, Cross JT, Abernethy DR. 1999. Pharmacokinetics and clinical effectiveness of methylphenidate. Clin Pharmacokinet 37:457-470.
75. Kita T, Wagner GC, Nakashima T. 2003. Current research on methamphetamine-induced neurotoxicity: animal models of monoamine disruption. J Pharmacol Sci 92:178-195.
76. Klein RG, Landa B, Mattes JA, Klein DF. 1988. Methylphenidate and growth in hyperactive children. A controlled withdrawal study. Arch Gen Psychiatry 45:1127-1130.
77. Klein RG, Mannuzza S. 1988. Hyperactive boys almost grown up. III. Methylphenidate effects on ultimate height. Arch Gen Psychiatry 45: 1131-1134.
78. Knights RM, Hinton GG. 1969. The effects of methylphenidate (Ritalin) on the motor sacrifices and behavior of children with learning problems. J Nerv Ment Dis 148:643-653.
79. Koehler-Troy C, Strober M, Malenbaum R. 1986. Methylphenidate-induced mania in a prepubertal child. J Clin Psychiatry 47:566-567.
80. Kollins SH. 2003. Comparing the abuse potential of methylphenidate versus other stimulants: a review of available evidence and relevance to the ADHD patient. J Clin Psychiatry 64(Suppl):14-18.
81. Kollins SH, MacDonald EK, Rush CR. 2001. Assessing the abuse potential of methylphenidate in nonhuman and human subjects: a review. Pharmacol Biochem Behav 68:611-627.
82. Kuczenski R, Segal DS. 2002. Exposure of adolescent rats to oral methylphenidate: preferential effects on extracellular norepinephrine and absence of sensitization and cross-sensitization to methamphetamine. J Neurosci 22:7264-7271.
83. Lahat E, Weiss M, Ben-Shlomo A, Evans S, Bistritzer T. 2000. Bone mineral density and turnover in children with attention-deficit hyperactivity disorder receiving methylphenidate. J Child Neurol 15:436-439.
84. Lambert NM. 2002. Stimulant treatment as a risk factor for nicotine use and substance abuse. In: Jensen PS, Cooper JR, editors. Attention Deficit Hyperactivity Disorder. Kingston, NJ: Civic Research Institute.
85. Lambert NM, Hartsough CS. 1998. Prospective study of tobacco smoking and substance dependencies among samples of ADHD and non-ADHD participants. J Learn Disabil 31:533-544.
86. Law SF, Schachar RJ. 1999. Do typical clinical doses of methylphenidate cause tics in children treated for attention-deficit hyperactivity disorder? J Am Acad Child Adolesc Psychiatry 38:944-951.
87. Leckman JF. 2003. Phenomenology of tics and natural history of tic disorders. Brain Dev 25:S24-S28.
88. Lipkin PH, Goldstein IJ, Adesman AR. 1994. Tics and dyskinesias associated with stimulant treatment in attention-deficit hyperactivity disorder. Arch Pediatr Adolesc Med 148:859-861.
89. Lisska MC, Rivkees SA. 2003. Daily methylphenidate use slows the growth of children: a community based study. J Pediatr Endocrinol Metab 16:711-718.
90. Loney J, Kramer JR, Salisbury H. 2002. Medicated versus unmedicated ADHD children: adult involvement with legal and illegal drugs. In: Jensen PS, Cooper JR, editors. Attention Deficit Hyperactivity Disorder. Kingston, NJ: Civic Research Institute. p 1-16.
91. Loney J, Whaley-Klahn MA, Ponto LB, Adney K. 1981. Predictors of adolescent height and weight in hyperkinetic boys treated with methylphenidate [proceedings]. Psychopharmacol Bull 17:132-134.
92. Lowe TL, Cohen DJ, Detlor J, Kremenitzer MW, Shaywitz BA. 1982. Stimulant medications precipitate Tourette's syndrome. JAMA 247: 1729-1731.
93. Lucas AR, Weiss M. 1971. Methylphenidate hallucinosis. JAMA 217: 1079-1081.
94. Madras BK, Miller GM, Fischman AJ. 2002. The dopamine transporter: relevance to attention deficit hyperactivity disorder (ADHD). Behav Brain Res 130:57-63.
95. Mallinckrodt. 2002. Methylin® and Methylin® ER product labeling. St. Louis, MO: Mallinckrodt, Inc.
96. Mallinckrodt. 2003. Methylin® chewable tablets product labeling. St. Louis, MO: Mallinckrodt, Inc.
97. Mannuzza S, Klein RG, Moulton JL 3rd. 2003. Does stimulant treatment place children at risk for adult substance abuse? A controlled, prospective follow-up study. J Child Adolesc Psychopharmacol 13: 273-282.
98. Markowitz JS, Morrison SD, DeVane CL. 1999. Drug interactions with psychostimulants. Int Clin Psychopharmacol 14:1-18.
99. Markowitz JS, Patrick KS. 2001. Pharmacokinetic and pharmacodynamic drug interactions in the treatment of attention-deficit hyperactivity disorder. Clin Pharmacokinet 40:753-772.
100. Mattes JA, Gittelman R. 1983. Growth of hyperactive children on maintenance regimen of methylphenidate. Arch Gen Psychiatry 40: 317-321.
101. Matthews EJ, Spalding JW, Tennant RW. 1993. Transformation of BALB/c-3T3 cells: V. Transformation responses of 168 chemicals compared to mutagenicity in Salmonella and carcinogenicity in rodent bioassays. Environ Health Perspect 2:347-482.
102. McDougall SA, Collins RL, Karper PE, Watson JB, Crawford CA. 1999. Effects of repeated methylphenidate treatment in the young rat: sensitization of both locomotor activity and stereotyped sniffing. Exp Clin Psychopharmacol 7:208-218.
103. McNutt B, Ballard JE, Boileau R. 1976. The effects of long-term stimulant medication on growth and body composition of hyperactive children. Psychopharmacol Bull 12:13-15.
104. McNutt BA, Boileau RA, Cohen MN. 1977. The effects of long-term stimulant medication on the growth and body composition of hyperactive children [proceedings]. Psychopharmacol Bull 13:36-38.
105. Mehta H, Murray B, Loludice TA. 1984. Hepatic dysfunction due to intravenous abuse of methylphenidate hydrochloride. J Clin Gastroenterol 6:149-151.
106. Millichap JG. 1978a. Dr. Gross's findings supported. Pediatrics 61: 146-147.
107. Millichap JG. 1978b. Growth of hyperactive children treated with methylphenidate. J Learn Disabil 11:567-570.
108. Mizutani T, Lewis RA, Gonatas NK. 1980. Medial medullary syndrome in a drug abuser. Arch Neurol 37:425-428.
109. Modi NB, Wang B, Noveck RJ, Gupta SK. 2000. Dose-proportional and stereospecific pharmacokinetics of methylphenidate delivered using an osmotic, controlled-release oral delivery system. J Clin Pharmacol 40:1141-1149.
110. Morrissey RE, Schwetz BA, Lamb Jc IV, Ross MD, Teague JL, Morris RW. 1988. Evaluation of rodent sperm, vaginal cytology, and reproductive organ weight data from National Toxicology Program 13-week studies. Fund Appl Toxicol 11:343-358.
111. MTA Cooperative Group. 1999. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. The MTA Cooperative Group. Multimodal treatment study of children with ADHD. Arch Gen Psychiatry 56:1073-1086.
112. MTA Cooperative Group. 2004. National Institute of Mental Health Multimodal Treatment Study of ADHD follow-up: changes in effectiveness and growth after the end of treatment. Pediatrics 113: 762-769.
113. National High Blood Pressure Education Program Working Group. 2004. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics 114: 555-576.
114. NIDA. 2003. InfoFacts: methyphenidate (Ritalin). Available at http://165.112.78.61/Infofax/ritalin.html. National Institute on Drug Abuse.
115. NIOSH. 2002. RTECS report for 2-piperidineacetic acid, α-phenyl-, methyl ester, hydrochloride (CAS#: 298-59-9). Available at http://www.cdc.gov/ niosh/rtecs/tm3abf10.html. National Institute of Occupational Safety and Health.
116. Novartis. 2001a. Focalin® product labeling. East Hanover, NJ: Novartis Pharmaceuticals Corporation.
117. Novartis. 2001b. Ritalin® and Ritalin-SR® product labeling. East Hanover, NJ: Novartis Pharmaceuticals Corporation.
118. Novartis. 2001c. Ritalin® LA extended-release capsules product labeling. East Hanover, NJ: Novartis Pharmaceuticals Corporation.
119. NTP. 1989. Methylphenidate HCl reproduction and fertility assessment in swiss CD-1 mice when administered via feed. Research Triangle Park, NC: National Toxicology Program, National Institute of Environmental Health Sciences. Report nr NTP-89-107.
120. NTP 1995. Toxicology and carcinogenesis studies of methylphenidate hydrochloride (CAS no. 298-59-9) in F344/N rats and B6C3F1 mice (feed studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Toxicology Program. Report nr NTP TR 439.
121. Paternite CE, Loney J, Salisbury H, Whaley MA. 1999. Childhood inattention-overactivity, aggression, and stimulant medication history as predictors of young adult outcomes. J Child Adolesc Psychopharmacol 9:169-184.
122. Pizzi WJ, Rode EC, Barnhart JE. 1986. Methylphenidate and growth: demonstration of a growth impairment and a growth-rebound phenomenon. Dev Pharmacol Ther 9:361-368.
123. Pizzi WJ, Rode EC, Barnhart JE. 1987. Differential effects of methylphenidate on the growth of neonatal and adolescent rats. Neurotoxicol Teratol 9:107-111.
124. Poulton A, Cowell CT. 2003. Slowing of growth in height and weight on stimulants: a characteristic pattern. J Paediarr Child Health 39:180-185.
125. Price RA, Leckman JF, Pauls DL, Cohen DJ, Kidd KK. 1986. Gilles de la Tourette's syndrome: tics and central nervous system stimulants in twins and nontwins. Neurology 36:232-237.
126. Quinn PO, Rapoport JL. 1975. One-year follow-up of hyperactive boys treated with imipramine or methylphenidate. Am J Psychiatry 132: 241-245.
127. Rao JK, Julius JR, Breen TJ, Blethen SL. 1998. Response to growth hormone in attention deficit hyperactivity disorder: effects of methylphenidate and pemoline therapy. Pediatrics 102:497-500.
128. Rapoport JL, Quinn PO, Bradbard G, Riddle D, Brooks E. 1974. Imipramine and methylphenidate treatments of hyperactive boys. A double-blind comparison. Arch Gen Psychiatry 30:789-793.
129. Rapport MD, Moffitt C. 2002. Attention deficit/hyperactivity disorder and methylphenidate. A review of height/weight, cardiovascular, and somatic complaint side effects. Clin Psychol Rev 22:1107-1131.
130. Safer D, Allen R, Barr E. 1972. Depression of growth in hyperactive children on stimulant drugs. N Engl J Med 287:217-220.
131. Safer DJ, Allen RP. 1973. Factors influencing the suppressant effects of two stimulant drugs on the growth of hyperactive children. Pediatrics 51:660-667.
132. Safer DJ, Allen RP, Barr E. 1975. Growth rebound after termination of stimulant drugs. J Pediatr 86:113-116.
133. Santosh PJ, Taylor E. 2000. Stimulant drugs. Eur Child Adolesc Psychiatry 9(Suppl):27-43.
134. Satterfield JH, Cantwell DP, Schell A, Blaschke T. 1979. Growth of hyperactive children treated with methylphenidate. Arch Gen Psychiatry 36:212-217.
135. Satterfield JH, Schell AM, Barb SD. 1980. Potential risk of prolonged administration of stimulant medication for hyperactive children. J Dev Behav Pediatr 1:102-107.
136. Schachar RJ, Tannock R, Cunningham C, Corkum PV. 1997. Behavioral, situational, and temporal effects of treatment of ADHD with methylphenidate. J Am Acad Child Adolesc Psychiatry 36:754-763.
137. Schachter HM, Pham B, King J, Langford S, Moher D. 2001. How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis. CMAJ 165:1475-1488.
138. Schertz M, Adesman AR, Alfieri NE, Bienkowski RS. 1996. Predictors of weight loss in children with attention deficit hyperactivity disorder treated with stimulant medication. Pediatrics 98:763-769.
139. Schmidt RA, Glenny RW, Godwin JD, Hampson NB, Cantino ME, Reichenbach DD. 1991. Panlobular emphysema in young intravenous Ritalin abusers. Am Rev Respir Dis 143:649-656.
140. Schultz FR, Hayford JT, Wolraich ML, Hintz RL, Thompson RG. 1982. Methylphenidate treatment of hyperactive children: effects on the hypothalamic-pituitary-somatomedin axis. Pediatrics 70:987-992.
141. Searight HR, Burke JM, Rottnek F. 2000. Adult ADHD: evaluation and treatment in family medicine. Am Fam Physician 62:2077-2086, 2091-2072.
142. Selby JV, Friedman GD, Fireman BH. 1989. Screening prescription drugs for possible carcinogenicity: eleven to fifteen years of follow-up. Cancer Res 49:5736-5747.
143. Shapiro AK, Shapiro E. 1981, Do stimulants provoke, cause, or exacerbate tics and Tourette syndrome? Compr Psychiatry 22:265-273.
144. Shaywitz SE, Hunt RD, Jatlow P, Cohen DJ, Young JG, Pierce RN, Anderson GM, Shaywitz BA. 1982. Psychopharmacology of attention deficit disorder: pharmacokinetic, neuroendocrine, and behavioral measures following acute and chronic treatment with methylphenidate. Pediatrics 69:688-694.
145. Sherman CB, Hudson LD, Pierson DJ. 1987. Severe precocious emphysema in intravenous methylphenidate (Ritalin) abusers. Chest 92:1085-1087.
146. Solanto MV. 2000. Clinical psychopharmacology of AD/HD: implications for animal models. Neurosci Biobehav Rev 24:27-30.
147. Spencer T, Biederman J, Wright V, Danon M. 1992. Growth deficits in children treated with desipramine: a controlled study. J Am Acad Child Adolesc Psychiatry 31:235-243.
148. Spencer TJ, Biederman J, Harding M, O'Donnell D, Faraone SV, Wilens TE. 1996. Growth deficits in ADHD children revisited: evidence for disorder-associated growth delays? J Am Acad Child Adolesc Psychiatry 35:1460-1469.
149. Srinivas NR, Hubbard JW, Quinn D, Midha KK. 1992. Enantioselective pharmacokinetics and pharmacodynamics of dl-threo-methylphenidate in children with attention deficit hyperactivity disorder. Clin Pharmacol Ther 52:561-568.
150. Srinivas NR, Lim HK, Hubbard JW, Midha KK. 1991. Evidence that dogs do not model enantioselective pharmacokinetics of dl-methylphenidate in humans. J Pharm Sci 80:707-708.
151. Srinivas NR, Quinn D, Hubbard JW, Midha KK. 1987. Stereoselective disposition of methylphenidate in children with attention-deficit disorder. J Pharmacol Exp Ther 241:300-306.
152. Sund AM, Zeiner P 2002. Does extended medication with amphetamine or methylphenidate reduce growth in hyperactive children? Nord J Psychiatry 56:53-57.
153. Sverd J, Gadow KD, Paolicelli LM. 1989. Methylphenidate treatment of attention-deficit hyperactivity disorder in boys with Tourette's syndrome. J Am Acad Child Adolesc Psychiatry 28:574-579; discussion 580-572.
154. Teo S, Stirling D, Thomas S, Hoberman A, Kiorpes A, Khetani V. 2002a. A 90-day oral gavage toxicity study of D-methylphenidate and D,L-methylphenidate in Sprague-Dawley rats. Toxicology 179:183-196.
155. Teo SK, San RH, Wagner VO, Gudi R, Stirling DI, Thomas SD, Khetani VD. 2003a. D-Methylphenidate is non-genotoxic in in vitro and in vivo assays. Mutat Res 537:67-79.
156. Teo SK, Stirling DI, Hoberman AM, Christian MS, Thomas SD, Khetani VD. 2003b. D-methylphenidate and D,L-methylphenidate are not developmental toxicants in rats and rabbits. Birth Defects Res Part B Dev Reprod Toxicol 68:162-171.
157. Teo SK, Stirling DI, Thomas SD, Evans MG, Khetani VD. 2003c. A 90-day oral gavage toxicity study of D-methylphenidate and D,L-methylphenidate in beagle dogs. Int J Toxicol 22:215-226.
158. Teo SK, Stirling DI, Thomas SD, Hoberman AM, Christian MS, Khetani VD. 2002b. The perinatal and postnatal toxicity of D-methylphenidate and D,L-methylphenidate in rats. Reprod Toxicol 16:353-366.
159. Teter CJ, McCabe SE, Boyd CJ, Guthrie SK. 2003. Illicit methylphenidate use in an undergraduate student sample: prevalence and risk factors. Pharmacotherapy 23:609-617.
160. Tourette's Syndrome Study Group. 2002. Treatment of ADHD in children with tics: a randomized controlled trial. Neurology 58:527-536.
161. UN. 2002. Psychotropic substances. Available at http://www.incb.org/e/ index.htm?: United Nations International Narcotics Control Board.
162. Varley CK, Vincent J, Varley P, Calderon R. 2001. Emergence of tics in children with attention deficit hyperactivity disorder treated with stimulant medications. Compr Psychiatry 42:228-233.
163. Wagner GC, Schuster CR, Seiden LS. 1981. Neurochemical consequences following administration of CNS stimulants to the neonatal rat. Pharmacol Biochem Behav 14:117-119.
164. Walker AP, Dumars KW. 1977. Commonly used pediatric drugs, sister chromatid exchanges and the cell cycle. Am J Hum Genet 29:110A.
165. Wargin W, Patrick K, Kilts C, Gualtieri CT, Ellington K, Mueller RA, Kraemer G, Breese GR. 1983. Pharmacokinetics of methylphenidate in man, rat and monkey. J Pharmacol Exp Ther 226:382-386.
166. Wilens T. 2002. Attention deficit hyperactivity disorder and substance abuse disorders-the nature relationship, subtypes at risk, and treatment issues. In: Jensen PS, Cooper JR, editors. Attention Deficit Hyperactivity Disorder. Kingston, NJ: Civic Research Institute. p 1-17.
167. Wilens TE, Faraone SV, Biederman J, Gunawardene S. 2003. Does stimulant therapy of attention-deficit/hyperactivity disorder beget later substance abuse? A meta-analytic review of the literature. Pediatrics 111:179-185.
168. Winsberg BG, Kupietz SS, Sverg J, Hungund BL, Young NL. 1982. Methylphenidate oral dose plasma concentrations and behavioral response in children. Psychopharmacology (Berl) 76:329-332.
169. Woodworth T. 2000. DEA congressional testimony before the: committee on education and the workforce: subcommittee on early childhood, youth and families. Available at http://www.dea.gov/pubs/cngrtest/ct051600.htm. U.S. Drug Enforcement Administration.
170. Young JG. 1981. Methylphenidate-induced hallucinosis: case histories and possible mechanisms of action. J Dev Behav Pediatr 2:35-38.
171. Zeiner P. 1995. Body growth and cardiovascular function after extended treatment (1.75 years) with methylphenidate in boys with attention-deficit hyperactivity disorder. J Child Adolesc Psychopharmacol 5:129-138.