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Which of the following statements related to adverse drug reactions (ADRs) is correct?

A. Drugs seldom exert their beneficial effects without also causing ADRs - this therapeutic dilemma lends credence to the statement that there are no “absolutely” safe biologically active agents. B. With the exception of overdose, an ADR is defined as “a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.” C. The FDA has one of the most rigorous approval requirements in the world to authorize the marketing of new drugs; however, clinical trials cannot, nor are they expected to uncover every potential ADR. D. All of the above.

All of the following statements related to ADRs are correct EXCEPT which one?

A. In order to have a 95 percent chance of detecting an ADR with an incidence of 1 in 1,000 subjects, a population of 30,000 would have to be exposed to a drug. B. The term "side effect," as used in the past, described not only negative (unfavorable) reactions; but, at times, concurrent positive (favorable) effects as well – the term should not be regarded as synonymous with ADRs. C. ARDs may be explained by one of five mechanisms: (1) “on-target” adverse reactions, (2) “off-target” adverse reactions, (3) cytotoxic reactions, (4) immune-mediated reactions, and (5) idiosyncratic reactions. D. A drug or drug class may produce toxic or adverse reactions by one or several of mechanisms of ADRs.

Which of the following statements related to “on-target” mechanisms of ADRs is correct?

A. An “on-target” ADRs may occur when a drug interacts with its intended receptor in the intended tissue. B. An “on-target” ADR may also occur when a drug interacts with its intended receptor, but in an unintended tissue. C. Local anesthetic agents intended to block sodium channels in neuronal tissues at the site of its administration with high plasma levels can cause sodium channel blockade in the heart. D. All of the above.

Which of the following statements related to “off-target” mechanisms of ADRs is correct?

A. An “off target” ADR can occur when a drug interacts with an unintended receptor either in an intended or in an unintended tissue. B. An example of an “off-target” ADR is when a β₂-adrenergic receptor agonist used to treat asthma also interacts with β₁-adrenergic receptors in the heart. C. An example of an “off-target” ADR uncovered during post-marketing period, which resulted in the withdrawal of the drug from the market, occurred when terfenadine, an H₁-histamine receptor blocking agent also interacted with unintended receptors (potassium channels) in an unintended tissue (heart). D. All of the above.

All of the following statements related to cytotoxic mechanism of ADRs specific to APAP toxicity are correct EXCEPT which one?

A. When APAP undergoes oxidation by CYP450 isoenzyme 2E1 into N-acetyl-p-benzoquinoneimine (NAPQI), this highly reactive metabolite is conjugated into APAP-glucuronide and APAP-sulfate. B. When glutathione stores are depleted, NAPQI accumulates and attacks cellular and mitochondrial proteins in the liver, which may lead to hepatic fibrosis or necrosis. C. Moderate doses of a toxic drug or metabolite activate mechanisms that result in programmed cell death (apoptosis) and tissue fibrosis. D. High doses of a toxic drug or metabolite activate mechanisms that lead to uncontrolled cell death and tissue necrosis.

All of the following statements related to “on-target,” “off-target,” and cytotoxic ADRs are correct EXCEPT which one?

A. “On-target,” “off-target,” and cytotoxic ADRs have a pharmacokinetic or a pharmacodynamic basis. B. “On-target,” “off-target,” and cytotoxic ADRs, with the exception of overdose, are precipitated by drug-drug, drug-food, drug-herbal, and drug-disease interactions with therapeutic doses of a drug. C. The risk of ADRs depends on the margin of safety between the dose of a drug required for efficacy and the dose that causes ADRs. D. When the margin of safety is small, ADRs result primarily from overdose; when the margin of safety is large, ADRs may manifest at therapeutic doses.

Which of the following statements related to pharmacokinetic drug-drug interaction is correct?

A. The plasma level of a drug depends on the dosage administered and the drug’s rate of absorption, distribution, metabolism, and clearance. B. Pharmacokinetic processes may be altered, i.e., induced or inhibited by drug-drug interactions. C. The interaction between opioid analgesics and APAP is an example of a pharmacokinetic drug-drug interaction affecting the absorption of APAP. D. All of the above.

All of the following statements related to pharmacodynamic drug-drug interactions are correct EXCEPT which one?

A. The intended or unintended effect produced by a given plasma level of a drug may result from chronic use of a drug or the presence of one or more drugs. B. Pharmacodynamic ADRs are the result of receptor alterations, and pharmacological, physiological, and chemical drug-drug interactions. C. The interaction between NSAIDs and antihypertensive agents is an example of a pharmacological drug-drug interaction. D. An example of a beneficial pharmacodynamic drug-drug interaction is illustrated by the interaction between phentolamine mesylate and epinephrine.

Which of the following statements related to drug-food and drug-herbal interactions is correct?

A. Nutrients can act as mechanical barriers and protect the gastric mucosa from irritants; but they can also prevent drug-access to mucosal surfaces and reduce or slow the absorption of some drugs. B. Components of grapefruit inhibit CYP450 isoenzyme 3A4 and increase the plasma level of a number of drugs; for example, it can significantly enhance the anticoagulant effect of warfarin. C. Ginkgo biloba inhibits platelet function; its use with acetylsalicylic acid (ASA), other nonsteroidal antiinflammatory agents (NSAIDs), and clopedigrel, which also interfere with platelet aggregation, increases the risk of bleeding. D. All of the above.

All of the following statements related to cytotoxic ADRs are correct EXCEPT which one?

A. Depending on the severity of the toxic insult cytotoxicity may manifest as apoptosis, i.e., uncontrolled cell death. B. Apoptosis is genetically directed self-destruction of DNA-damaged cells and, may lead to fibrosis. C. If the toxic insult is severe, programmed cell death cannot be accomplished and the cells undergo necrosis. D. Necrosis is characterized by autolysis of damaged cells, inflammation, and damage to nearby healthy tissues.

Which of the following statements related to overdose is correct?

A. Generally, with overdose, the effects of drugs are exaggerated, ADRs become more pronounced, and other, unexpected reactions may be observed. B. Nearly half of all opioid overdose deaths are related to prescription opioid analgesics, often in combination with alcohol and sedatives. C. An opioid overdose can reliably be identified by the presence of three clinical signs and symptoms referred to as the “opioid overdose triad”: (1) pinpoint pupils (miosis), (2) unconsciousness, and (3) respiratory depression. D. All of the above.

All of the following statements related to ADRs affecting oral tissues are correct EXCEPT which one?

A. Xerostomia (ranked #28) and taste disturbances (ranked #30) are among the 30 most common ADRs identified with the top 200 drugs dispensed by U.S. community pharmacies. B. Stomatitis and ulcerative stomatitis represent cytotoxic reactions to topically applied agents, e.g., LAs; or may result from the systemic administration of cytotoxic drugs, e.g., antineoplastic agents. C. Antibacterial and corticosteroid therapy is often complicated by superinfection with candidal organisms in oral tissues. D. A common ADR related to bisphosphonates is medication-related osteonecrosis of the jaw precipitated by dentoalveolar trauma.

Which of the following statements related to ADRs affecting the gastrointestinal system is correct?

A. Nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, and anorexia are among the 30 most common potential ADRs associated with therapeutic dosages of the top 200 drugs dispensed by U.S. community pharmacies. B. The ulcerogenic effect of NSAIDs is well established and is attributable to inhibition of prostaglan¬din synthesis. C. Of particular concern to oral healthcare providers should be the patient complaining of lower abdominal pain, acute diarrhea with blood in the stool that is currently taking or has been prescribed in the recent past clindamycin or a broader spectrum penicillin or cephalosporin. D. All of the above.

All of the following statements related to ADRs affecting the liver and biliary system are correct EXCEPT which one?

A. During the past decade APAP has been identified as the leading cause of acute liver failure (ALF) in the United States and up to 50% of APAP-related cases of ALF are due to unintentional overdose. B. Clinical signs and symptoms of APAP overdose include nausea, vomiting, abdominal pain, anorexia, and a few days later, elevated bilirubin presents as jaundice. C. The FDA formally withdrew from the market all prescription combination analgesics containing more than 650 mg of APAP per unit dose. D. APAP, 650 mg per dose, q4h, may still be prescribed.

All of the following statements related to ADRs affecting the ears are correct EXCEPT which one?

A. Dizziness is the most common potential ADR associated with therapeutic dosages of the top 200 drugs dispensed by U.S. community pharmacies. B. Dizziness is an imprecise term describing various related sensations such as faintness, a feeling of impending syncope; light-headedness; and a feeling of imbalance. C. Vertigo is described by patients as noise in the ears such as buzzing, ringing, roaring, whistling, hissing, or pulsating. D. Potentially ototoxic drugs prescribed by dentist include antibiotics such as metronidazole, clindamycin, and macrolides.

Which the following statement related to ADRs affecting the cardiovascular and respiratory systems is correct?

A. Common drugs that produce postural hypotension include diuretics, α₁ and β₁-receptor blockers, nitrates, digitalis, ACE-inhibitors, and calcium channel blockers. B. Macrolide antibiotics are known to cause cardiac arrhythmias characterized by prolongation of the QT interval, palpitations, hypotension, and chest pain. C. Dyspnea may be caused by drugs prescribed by dentists such as opioids and NSAIDs. D. All of the above.

Which of the following statements related to ADRs affecting the urinary system is correct?

A. The chronic use of NSAIDs can lead to direct nephrotoxicity called analgesic nephropathy, related to the inhibition of prostaglandin synthetase resulting in reduced glomerular blood flow and acute renal failure. B. Urinary incontinence is the involuntary loss of urine - diuretics, alcohol, and caffeine increase urine production leading to increased frequency, urgency and nocturia. C. Opioid analgesics also can cause urinary retention, and like psychotropic drugs such as benzodiazepines, antidepressants, and antipsychotic agents may affect incontinence by blunting awareness to void. D. All of the above.

All of the following statements related to ADRs affecting the neuropsychiatric system except which one?

A. Somnolence, sleepiness or drowsiness, is a symptom characterized by a state of strong desire for sleeping or sleeping for unusually long periods. B. Insomnia is a symptom characterized by difficulty in falling to sleep or to stay asleep - drug-related insomnia may be associated with chronic use of drugs or result from drug withdrawal such as opioid analgesics of benzodiazepines. C. Dietary causes of depression include caffeine and monosodium glutamate (Chinese-restaurant syndrome). D. Anxiety is the distressing experience of dread and foreboding; unpleasant emotional experience characterized nervousness, uneasiness, and fear.

All of the following statements related to ADRs affecting the peripheral and central nervous systems are correct EXCEPT which one?

A. Primary headache may be a symptom of exposure to monosodium glutamate (MSG); analgesic overdose; caffeine withdrawal; and treatment with nitrates. B. Symptoms of tardive dyskinesia include oral dyskinesia, i.e., involuntary muscle movements characterized by continual chewing, intermittent darting of the tongue (fly fishing) and lip-smacking, pursing, or puckering. C. Drugs associated with paresthesia include LAs, long-term exposure to nitrous oxide, mercury poisoning, led poisoning, anticonvulsant drugs; and withdrawal of benzodiazepines. D. Drugs that can increase heat production, i.e., cause fever, include amphetamines, cocaine, general anesthetics, and antipsychotic agents.

All of the following statements related to ADRs affecting the endocrine/metabolic system are correct EXCEPT which one?

A. Increased rates of insulin absorption associated with increased skin temperature, heavy exercise, anxiety, infection, and pain lead to hypoglycemia. B. Insulin and/or oral hypoglycemic agents in the absence of adequate intake of carbohydrates lead to hypoglycemia. C. Glutamate-related manifestations of hypoglycemia include twitching, tremor, anxiety, nervousness, sweating, pallor, cold and clammy skin, and mydriasis. D. Neuroglycopenic manifestations include fatigue, weakness, lethargy, paresthesia, headache, reduced mental capacity, impairment of action and judgment, focal or generalized seizure, and coma.

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Adverse Drug Reactions - Part I
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Adverse Drug Reactions - Part I
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