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91 Cards in this Set
- Front
- Back
What 3 things does drug development begin with?
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discovery and characteristics of new drug
clinical studies regulatory approval |
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process of evaluating drug safety and efficacy as well as adverse effects and interactions caused by drugs
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drug development
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What are the 7 steps of drug development?
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discovery of characteristics of new drug
experimental studies IND application clinical studies submission of NDA approval of NDA post marketing |
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new drug compound synthesized or isolated from natural produce in chemical laboratory; subjected to screening test to determine effect/pharmacological properties of a drug
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discovery of characteristics of new drug
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What is a case of accidental discovery of some pharmacological effects?
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clonidine
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pharmacological effects of agent must be investigated in animals prior to use in humans; designed to detect beneficial and harmful cardiovascular, renal, and respiratory effects
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experimental studies
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What do federal regulations require extensive studies for?
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toxicology
teratogenicity mutagenicity carcinogenicity |
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What are experimental studies used to determine?
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MOA
Pk Pd properties of agent adverse effects |
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Who must approve the Investigational New Drug (IND) Application?
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FDA
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What includes complete description of drug and its properties?
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investigational new drug (IND)
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What does the IND include?
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results of all experimental studies
proposed clinical studies proposed study sites, investigators, protocols, methods, and analysis |
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gather information on drug safety, Pk in healthy human subjects (volunteers)
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clinical studies (phase 1)
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Pk analysis done to determine dosing for next phase
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clinical studies (phase 1)
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studies performed in human subjects with disease state in which IND is to be used
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clinical studies (phase 2)
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assess efficacy and safety and help establish dosage ranges for further studies; typically involve small number of patients
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clinical studies (phase 2)
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involve larger group of subjects and multiple clinical sites and investigators
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clincial studies (phase 3)
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designed to prevent investigator bias and often double blind and placebo controlled
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clincial studies (phase 3)
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compare efficacy and safety of new drug with that of other agents
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clincial studies (phase 3)
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outlines the properties of the drug and reports results of all experimental and clinical studies
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new drug application (NDA)
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contains proposed labeling of drug, clinical indications, dosing, etc.
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new drug application (NDA)
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involves gathering and analyzing voluntary reports of adverse effects; submitted by health care practitioners
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post-marketing surveillance
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federal legislation concerning drug product safety and efficacy in US
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Pure Food and Drug Act
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passed in response to sale of medications containing toxic and habit-forming ingredients
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Pure Food and Drug Act
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required accurate labeling of ingredients in drug products
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Pure Food and Drug Act
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saught to prevent the adulteration of drugs thru substitution of toxic ingredients for labeled ingredients
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Pure Food and Drug Act
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passed in response to tragic incident involving sulfanilamide and ethylene glycol
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Food, Drug, and Cosmetic Act
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made strides in requiring evidence of drug safety prior to its marketing
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Food, Drug, and Cosmetic Act
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FDA established to enforce this act
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Food, Drug, and Cosmetic Act
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legal authority given to drug product standards
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United States Pharmacopeia (USP)
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contains information on chemical analysis of drugs and indicates how much variance in content is allowed for each drug product
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Food, Drug, and Cosmetic Act
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outlines standard for tablet disintegration
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United States Pharmacopeia
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prohibits distribution of drug products that are adulterated, misbranded (mislabeled) or that do not have an approved NDA
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Food, Drug, and Cosmetic Act
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not meeting USP standards or not manufactured by "good manufacturing" practices
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adulterated products
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contain the name, dose, and quantity of ingredients and warnings against unsafe use
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drug product labels
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prompted by growing problem of heroin abuse
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Harrison Narcotic Act
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1st major drug abuse legislation in USA
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Harrison Narcotic Act
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sought to control narcotic use through use of tax stamps
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Harrison Narcotic Act
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prevented physicians from adminstering drugs to addicts as part of Rx plan
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Harrison Narcotic Act
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often called the Controlled Substance Act
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Comprehensive Drug Abuse Prevention and Control Act
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passed in response to prevalent drug abuse in the 1960s in adolescent and young adults
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Comprehensive Drug Abuse Prevention and Control Act
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included sedatives, stimulants, LSD, marijauna, and other hallucinogens
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Comprehensive Drug Abuse Prevention and Control Act
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classified abused drugs into 5 schedules based on their potential for abuse
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Comprehensive Drug Abuse Prevention and Control Act
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high potential for abuse, no legitimate medical use, possession prohibited
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Schedule I
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high potential for abuse; legitimate medical use; distribution legal, but inventories are controlled, there are record keeping requirements and prescription requirements
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Schedule II
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lower abuse potential; fewer restrictions on distribution
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Schedules III, IV, V
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required distributors, practitioners, and medical institutions to register with the DEA
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Comprehensive Drug Abuse Prevention and Control Act
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DEA is responsible for enforcing act
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Comprehensive Drug Abuse Prevention and Control Act
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unexpected, unintended effect of a drug that may lead to drug discontinuation, treatment with another drug, hospitalization, etc.
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adverse drug reaction (ADR)
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results from allergens, responsible for toxicities; range from skin rash to major organ toxicity
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hypersensitivity reactions
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results from the adverse interaction of antigens/antibodies
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allergic reaction
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immediate hypersensitivity reaction
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Type I Hypersentivity
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mediated by immune globulin (IgE) antibodies
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Type I Hypersentivity
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examples include urticaria, atomic dermatitis, anaphylactic shock
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Type I Hypersentivity
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mediated by immune complex
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Type III Hypersentivity
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antigen/antibody deposited in vascular endothelial system causing inflammation, lymph edema, and fever
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Type III Hypersentivity
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examples include sever drug induced vasculitis-Steven Johnson's syndrome
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Type III Hypersentivity
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delayed hypersensitivity reaction
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Type IV Hypersentivity
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mediated by sensitized lymphocytes
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Type IV Hypersentivity
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examples include ampicillin skin rash occurring with viral mononucleosis
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Type IV Hypersentivity
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cytolytic reaction mediated by IgG and IgM
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Type II Hypersentivity
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examples include hemolytic anemia and thrombocytopenia
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Type II Hypersenstivity
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unexpected reaction caused by genetically determined susceptibility
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idiosyncratic reaction
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examples include patients with glucose 6phosphate dehydrogenase deficiency-hemolytic reaction from primaquine
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idiosyncratic reaction
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caused by immunologic mechanism or via direct effect on hepatocytes
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hepatotoxicity
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may be detected by checking transaminase levels
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hepatotoxicity
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caused by hypersensitivity mechanism, leading to inflammation, stasis of biliary system
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cholestatic
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sometimes caused by toxic drug
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hepatocellular toxicity
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consider alternatives or frequent monitoring when these levels are 2x the upper limit
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elevated transaminase levels
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discontinue drug when these levels are 3x the upper limit
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elevated transaminase levels
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removed from market-excessive hepatic failure
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rezulin
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caused by many drugs, including ATBs
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nephrotoxicity
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What are 3 forms of renal toxicity?
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interstitial nephritis
renal tubular necrosis crystalluria |
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precipitation of insoluble drug in renal tubule
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crystalluria
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decrease clearance, increase plasma levels
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nephrotoxicity
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less common than renal toxicity; caused by cyclophosphamide hemorrhagic cystitis
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bladder toxicity
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some drugs cause respiratory depression
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pulmonary toxicity
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caused by Bleomycin, Amiodarone
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pulmonary fibrosis
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should have periodic x-rays and gas measurement to detect early signs of fibrosis
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pulmonary toxicity
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caused by anthracylines, such as doxorubicin (Adriamycin)
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cardiotoxicity
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HMG reductase inhibitors, such as Lovastatin (Mevacor)
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skeletal muscle toxicity
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skin rashes may include macular, papular rashes or urticaria (ie., antibiotics)
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dermatological toxicity
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a change in pharmacological effect of a drug that results when given concurrently with another drug
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drug interactions
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examples include PCN/Aminoglycosides, Quinolones/Antacids
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drug interactions
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What are 2 ways in which you might manage drug interactions?
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1. space out when you give the drugs
2. decrease dose of one |
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Adverse Effect: cardiac defects, cleft palate, growth retardation
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anticancer agents (antimetabolites)
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Adverse Effect: fetal warfarin syndrome
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Coumadin
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Adverse Effect: cervical adenocarcinoma
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Diethylstilbesterol (DES)
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Adverse Effect: fetal alcohol syndrome
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ethanol
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Adverse Effect: fetal hydantoin syndrome, cardiac defects, ear malformations
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phenytoin
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Adverse Effect: enamel hypoplasia, staining of teeth
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tetracycline
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Adverse Effect: deafness, heart defects, limb abnormalities
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thalidomide
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