Gene/Protein Disease Symptom Drug Enzyme Compound
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A review of the safety and tolerability of fluvoxamine in worldwide marketing studies involving 24,624 patients, predominantly receiving fluvoxamine treatment in uncontrolled studies in depression, has been conducted. There was a marked preponderance of female patients and patients aged between 30 and 50 years. The majority of patients were treated for 6 weeks, with the most frequent modal total daily dose being 100mg. The greatest proportion of adverse experiences occurring, by COSTART body system, affected the digestive system (24.1%), the nervous system (23.7%), and the body as a whole (15.3%). The only adverse experience with an incidence greater than 10% was nausea (15.7%), with somnolence (6.9%) and asthenia (6.2%) as the next most frequent experiences. Notably, the rates of agitation and anxiety were only 1.4 and 1.3%, respectively. The incidences of adverse experiences increased with age, and were slightly higher in females than males. 15.1% of patients discontinued treatment prematurely as a result of adverse experiences, principally nausea, dizziness, vomiting, somnolence, abdominal pain, and headache. The overall incidence of serious adverse events associated with fluvoxamine treatment was 2.5%, and the incidence of overall suicidality, including suicidal ideation, overdose, and intentional overdose as well as attempted and completed acts of suicide, was remarkably low at 0.8%.
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PMID:Review of fluvoxamine safety database. 137 74

Nonsalicylate, nonsteroidal anti-inflammatory drugs (NSAIDs) can be divided into 4 chemical classes: acetic acids, fenamic acids, oxicams and propionic acids. Most NSAID overdoses result in a benign outcome. Of 50,614 exposures reported to poison centres in the United States in a 2-year period, 131 (0.26%) had a major outcome, with 10 deaths. Despite the generally mild effects reported in large patient series, isolated case reports have documented serious toxicity, such as seizures, hypotension, apnoea, coma and renal failure. The majority of these consequences occur after ingestion of substantial quantities by adults attempting suicide. Rarely, with ibuprofen and piroxicam, children who ingest small amounts in accidental exposure develop serious toxicity. Typical signs and symptoms of NSAID overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness. Seizures are rarely documented across all NSAID classes, with the exception of mefenamic acid (where seizures occur in over one-third of cases), or following massive ingestion of other agents. Drugs in the propionic acid group have produced metabolic acidosis, respiratory depression and coma in severe cases. Ibuprofen is the agent with the most published data on overdose, probably because it is available without a prescription in many countries. Symptoms are unlikely after ingestion of 100 mg/kg or less, and are usually not life-threatening unless more than 400 mg/kg is ingested. There is some relationship between plasma concentrations and the potential for development of symptoms, but plasma concentrations have no impact on treatment decisions. Treatment of NSAID overdose is entirely supportive. Recent trends in emergency department procedures regarding gastric decontamination are evolving towards the recommended administration of activated charcoal without gastric emptying in patients presenting more than 1 hour after ingestion, although gastric lavage, followed by administration of activated charcoal, may be advisable in patients who present earlier. Home administration of syrup of ipecac is still recommended if treatment is given shortly after ingestion, with a few exceptions: for example, ipecac is contraindicated after ingestion of mefenamic acid or ibuprofen in amounts greater than 400 mg/kg. Urine alkalinisation and diuresis have been recommended to enhance the elimination of NSAIDs, based on a pKa in the range of 3 to 5. However, because the drugs are universally highly protein bound, with little unchanged renal excretion, this technique is not likely to be beneficial. Haemodialysis is also unlikely to enhance elimination, but may be required if oliguric renal failure develops. Multiple dose activated charcoal may be useful in enhancing elimination of NSAIDs with long half-lives, such as piroxicam and sulindac.
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PMID:Toxic effects of nonsteroidal anti-inflammatory drugs in overdose. An overview of recent evidence on clinical effects and dose-response relationships. 219 51

Safety aspects were compared in 2203 patients given moclobemide and 1214 who received other antidepressants or placebo. A total of 2294 adverse events were reported by patients on moclobemide, mainly subjective symptoms (28.6%). Adverse events such as dry mouth, tremor, sweating, dizziness and constipation occurred much more frequently among 681 patients treated with various tricyclic antidepressants than in the 694 moclobemide patients with whom they were compared. Among 271 placebo-treated patients there were 287 adverse events, compared with 386 events in the 285 moclobemide patients in the same studies. Hypertensive episodes or food-drug interactions were reported by 19 patients on moclobemide and 5 on other antidepressants, but in only 2 of the former was ingestion of cheese a possible cause of headache. The assessment of tolerance on moclobemide was essentially the same as for placebo. Of the 1401 moclobemide patients in the electronic database, only 3.2% stopped treatment prematurely because of poor tolerance; the rates were higher for tranylcypromine, nomifensine, desipramine, clomipramine, amitriptyline and imipramine. During treatment, 6 patients attempted suicide with moclobemide alone (950-2000 mg) or together with imipramine (300 mg and 1200 mg). None of the intoxications was life-threatening.
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PMID:Moclobemide (Ro 11-1163) safety in depressed patients. 224 78

Data is reviewed on premenstrual symptoms which have been related to high suicide and accident rates, employment absentee rates, poor academic performance and acute psychiatric problems. A recent study of healthy young women indicated that 39% had troublesome premenstrual symptoms, 54% passed clots in their menses, 70% had cyclical localized acneiform eruptions and only 17% failed to experience menstrual pain. Common menstrual disorders are classified as either dysmenorrhea or the premenstrual syndrome. Symptoms for the latter usually begin 2-12 days prior to menstruation and include nervous tension, irritability, anxiety, depression, bloated breasts and abdomen, swollen fingers and legs, headaches, dizziness, occasional hypersomia, excessive thirst and appetite. Some women may display an increased susceptibility to migraine, vasomotor rhinitis, asthma, urticaria and epilepsy. Symptoms are usually relieved with the onset of menses. While a definitive etiological theory remains to be substantiated, symptomatic relief has been reported with salt and water restriction and simple diuretics used 7 to 10 days premenstrually. Diazapam or chlordiazepoxide treatment is recommended before oral contraceptive therapy. The premenstrual syndrome may persist after menopause, is unaffected by parity, and sufferers score highly on neuroticism tests. Primary or spasmodic dysmenorrhea occurs in young women, tends to decline with age and parity and has no correlation with premenstrual symptoms or neuroticism. Spasmodic or colicky pain begins and is most severe on the first day of menstruation and may continue for 2-3 days. Treatment of dysmenorrhea with psychotropic drugs or narcotics is discouraged due to the risk of dependence and abuse. Temporary relief for disabling pain may be obtained with oral contraceptives containing synthetic estrogen and progestogen but the inherent risks should be acknowledged. Both disorders have been correlated to menstrual irregularity. Amenorrhea in many women may be precipitated by simple psychological events such as leaving home, while severely stressful events produce a higher incidence. Unless a physiological factor such as malnutrition is operating, menses usually recur spontaneously within a few months. Amenorrhea is a constant feature of anorexia nervosa and may precede related attitudes toward eating and body weight. This syndrome is best regarded as a chronic and often severe neurotic disorder requiring combined physiological and psychological treatment, although some evidence exists to indicate an endocrine disorder. Extensive basic research is needed on the complex relationship between the neuroendocrine system and emotion.
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PMID:Premenstrual symptoms. 473 36

Panic disorder is a chronic illness that affects at least 3 percent of the population. Panic disorder is associated with significant morbidity and an increased risk of suicide. Patients generally present with multiple somatic and psychologic complaints, including heart palpitations, chest pain, tremor, shortness of breath, choking, nausea or abdominal distress, dizziness, derealization, fear of losing control or going crazy, fear of dying, paresthesias, chills or hot flushes, headache, diarrhea, insomnia, chronic fatigue, anxiety and depression. To make the correct diagnosis, these symptoms must be evaluated carefully since they also occur with serious cardiovascular, pulmonary, endocrinologic and neurologic disorders. Many effective treatments are available, including tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, benzodiazepines such as alprazolam and clonazepam, and psychotherapy.
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PMID:Panic disorder. 748 99

Drugs part in traffic accidents is not well known. We attempted to specify it taking out of pawn the adverse effects which could be liable: drowsiness; consciousness lose; dizziness; eye-sight troubles; hallucinations, hearing troubles; drunken feelings, behaviour modification; propensy to suicide, interference with alcohol. Drugs involving such effects were indexed; their therapeutic indications and their chemical structure were taking into account. Statistical classical count allowed us to quantify relative importance of this ten adverse effects category. Multivariate analysis worked out structuration this undesirable effects into 97 different profiles by the mean of the Minimum Spanning Tree method and established proximity links between the 409 active principles recorded. This results are reported here.
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PMID:[Multiparameter approach to undesirable effects of drugs that may represent risk for the automobile driving]. 821 19

Psychogenic pain, disturbances of gait and stance, sensory symptoms, dizziness, and psychogenic seizures have been found to be the most common conversion symptoms in neurology clinics. A retrospective analysis of 18 patients suffering from pseudoseizure "status" is presented in this study. All of the patients fulfilled the DSM-III-R criteria of conversion disorder. However, 5 of them had concomitant major depression, 6 suffered from bulimia nervosa, and 7 met the criteria for substance abuse. On Axis II, 10 cases of borderline personality disorder, 2 cases of antisocial personality disorder, and 3 cases of histrionic personality disorder were diagnosed. The majority of the patients had attempted suicide and other forms of self-destructive behavior. The findings suggest that patients with pseudoseizure "status" suffer from severe affective imbalances and disturbed impulse control.
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PMID:Pseudoseizure "status". 919 24

The atypical antipsychotic agent clozapine is associated with a lower propensity for extrapyramidal symptoms than classical antipsychotic agents. The pharmacokinetics of clozapine are affected by wide interpatient variability and a potential for drug interactions. Some studies have shown a relationship between plasma concentrations, duration of treatment and antipsychotic clinical response. Clozapine (mean 274.2 mg/day; n = 490) had a greater preventive effect on suicidality among patients with schizophrenia or schizoaffective disorder at high risk for suicide than olanzapine (mean 16.6 mg/day; n = 490) in a randomised, rater-blinded, multicentre study (p < 0.05; a 22-24% improvement). Other prospective noncomparative trials of the effects of clozapine on suicidal ideation or attempts endorsed these results, while results from retrospective trials are equivocal. Clozapine is commonly associated with sedation, hypersalivation, tachycardia, dizziness, constipation and orthostatic hypotension. Agranulocytosis, diabetes mellitus and weight gain may also occur.
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PMID:Clozapine: in prevention of suicide in patients with schizophrenia or schizoaffective disorder. 1266 98

Duloxetine (Cymbalta(R)) is a potent serotonin and noradrenaline (norepinephrine) reuptake inhibitor (SNRI) in the CNS. It is indicated for the treatment of generalized anxiety disorder (GAD) as well as other indications. In patients with GAD of at least moderate severity, oral duloxetine 60-120 mg once daily was effective with regard to improvement from baseline in assessments of anxiety and functional impairment, and numerous other clinical endpoints. Longer-term duloxetine 60-120 mg once daily also demonstrated efficacy in preventing or delaying relapse in responders among patients with GAD. In addition, duloxetine was generally well tolerated, with most adverse events being of mild to moderate severity in patients with GAD in short- and longer-term trials. Additional comparative and pharmacoeconomic studies are required to position duloxetine among other selective serotonin reuptake inhibitors and SNRIs. However, available clinical data, and current treatment guidelines, indicate that duloxetine is an effective first-line treatment option for the management of GAD. Duloxetine is a potent and selective inhibitor of serotonin and noradrenaline transporters, and a weak inhibitor of dopamine transporters. It has a low affinity for neuronal receptors, such as alpha(1)- and alpha(2)-adrenergic, dopamine D(2), histamine H(1), muscarinic, opioid and serotonin receptors, as well as ion channel binding sites and other neurotransmitter transporters, such as choline and GABA transporters. It does not inhibit monoamine oxidase types A or B. The pharmacokinetics of duloxetine in healthy volunteers were dose proportional over the range of 40-120 mg once daily. Steady state was typically reached by day 3 of administration. Duloxetine may be administered without regard to food or time of day. Duloxetine is highly protein bound and is widely distributed throughout tissues. It is rapidly and extensively metabolized in the liver by cytochrome P450 (CYP) 1A2 and 2D6, and its numerous metabolites, which are inactive, are mainly excreted in the urine. The mean elimination half-life of duloxetine is approximately 12 hours. Duloxetine is a substrate for CYP1A2 and CYP2D6 and a moderate inhibitor of CYP2D6. Concomitant use of duloxetine and potent CYP1A2 inhibitors should be avoided and duloxetine should be used with caution in patients receiving drugs that are extensively metabolized by CYP2D6, particularly those with a narrow therapeutic index. Duloxetine was effective in the short-term treatment of patients with primary GAD of at least moderate severity. In four randomized, double-blind, placebo-controlled, multicentre, phase III trials, duloxetine 60-120 mg once daily for 9 or 10 weeks was significantly more effective than placebo with regard to the primary endpoint of mean change in Hamilton Anxiety Rating Scale (HAM-A) total score from baseline to study endpoint. In addition, all other endpoints were generally improved from baseline to a greater extent with duloxetine 60-120 mg once daily than with placebo. Duloxetine also improved patient role functioning (assessed using Sheehan Disability Scale global impairment functioning scores), health-related quality of life and patient well-being compared with placebo. Duloxetine was effective in patients with GAD who were aged >/=65 years. Pooled results of data from the two short-term efficacy trials that also included an active comparator arm showed that the mean change in HAM-A scores with duloxetine relative to placebo were of the same magnitude as those with venlafaxine extended release versus placebo. Duloxetine 60-120 mg once daily was also more effective than placebo in preventing or delaying relapse in responders to duloxetine in a longer-term study. In this study, patients with GAD received duloxetine during a 26-week, open-label, acute treatment phase and responders were then randomized to continue on duloxetine or receive placebo during a 26-week, double-blind, continuation phase. Time to relapse was significantly longer in duloxetine recipients than in placebo recipients. In addition, significantly fewer duloxetine recipients than placebo recipients relapsed during the double-blind phase of the trial and more duloxetine recipients achieved remission. Short- (9-10 weeks) and longer-term (52 weeks) treatment with duloxetine 60-120 mg once daily was generally well tolerated in patients with GAD, with the majority of adverse events being of mild to moderate severity. Nausea, dry mouth, headache, constipation, dizziness and fatigue were among the most common treatment-emergent adverse events. The adverse event profile of duloxetine did not differ with dose or treatment duration. Significantly more patients receiving short-term duloxetine than placebo discontinued treatment because of an adverse event, with nausea being the only event that resulted in significantly more treatment discontinuations in duloxetine recipients than in placebo recipients. Serious adverse events were uncommon with both short- and longer-term duloxetine treatment. Two episodes of attempted suicide and one episode of completed suicide occurred in duloxetine recipients during the 24-week open-label phase of a longer-term trial. No deaths or suicides were reported in any of the short-term trials. Discontinuation-emergent adverse events, most commonly nausea and dizziness, occurred in up to one-third of duloxetine recipients in the short-term trials.
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PMID:Duloxetine: a review of its use in the treatment of generalized anxiety disorder. 1948 Apr 70

A 52-year-old man was found dead in his bed. He had financial and psychosocial problems like separation from his wife and children or unemployment due to alcoholism. Under treatment of disulfiram he was presently abstinent from alcohol. As he had suffered from epileptic seizures and dizziness, he received valproic acid and the vasodilator naftidrofuryl, respectively. Autopsy showed no morphologic cause of death. Chemical analysis of blood revealed concentrations for valproic acid and disulfiram in the therapeutic and above the therapeutic range but far below the lethal level, respectively. No ethanol was found. However, the very high concentration of 7500 microg/L naftidrofuryl in whole blood was considered as cause of death, and the most probable manner of death seemed to be suicide. To our knowledge, this is the first reported case of a fatal poisoning with naftidrofuryl.
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PMID:Fatal intoxication with naftidrofuryl. 1952 May 96


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