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Query: UMLS:C0036572 (seizures)
 80,221 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The clinical trial development programme of mirtazapine (Org 3770), performed in Europe and the United States, demonstrated an outstanding safety profile of this compound. The evaluation of the safety was based on data from all patients who took at least one dose of study medication during studies comparing mirtazapine with placebo, amitriptyline or other active comparators. A general indication of mirtazapine's safety is the significantly lower percentage of patients (65%) who complained of any adverse clinical experiences compared with the placebo- (76%) or amitriptyline-treated group (87%). Moreover, drop-out rates due to adverse clinical experiences were significantly lower than in the amitriptyline-treatment group. Mirtazapine has virtually no anticholinergic, adrenergic or typical selective serotonin reuptake inhibitor (SSRI) side effects. The only significantly higher incidences versus placebo were seen in the adverse clinical effects of drowsiness (23% versus 14%), excessive sedation (19% versus 5%), dry mouth (25% versus 16%), increased appetite (11% versus 2%) and weight increase (10% versus 1%). These complaints were typically mild and transient in nature, and decreased over time despite increased doses of mirtazapine. In contrast, significantly higher incidences of headache (5% versus 10%) and weight decrease (2% versus 6%), symptoms commonly seen in depressed patients, were recorded in the placebo-treated patients. Also, typical SSRI adverse events, such as nausea, vomiting, diarrhoea and insomnia, and symptoms of sexual dysfunction were registered less frequently in mirtazapine-treated patients than in the placebo-treated patients. Approximately 10% of the mirtazapine-treated patients in the clinical trial programme were older than 65 years. The pattern of adverse clinical experiences seen in this group of patients is fully in line with that seen in the overall patient population. The analysis of vital sign indices, i.e. blood pressure and heart rate, showed that no changes occurred with mirtazapine treatment; this pattern was fully comparable to that seen with placebo. Furthermore, very low incidences of clinically relevant changes in laboratory indices, such as the liver enzymes alanine aminotransferase and aspartate aminotransferase or neutropenia, were recorded in each treatment group. Mirtazapine has a very low seizure-inducing potential: only one case was recorded in a patient with a history of seizures during previous treatment with clomipramine. The low seizure-inducing potential combined with a lack of cardiotoxic properties allows safety in an overdose of mirtazapine, even in elderly patients. The only symptom seen in the patients taking an overdose of mirtazapine alone or in combination with other drugs was excessive but transient somnolence, which resolved spontaneously within a few hours. In conclusion, the new antidepressant mirtazapine offers clinicians a unique combination of strong efficacy and good safety.
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PMID:Safety of mirtazapine: a review. 893 8

Nefazodone hydrochloride is a phenylpiperazine antidepressant with a mechanism of action that is distinct from those of other currently available drugs. It potently and selectively blocks postsynaptic serotonin (5-hydroxytryptamine; 5-HT) 5-HT2A receptors and moderately inhibits serotonin and noradrenaline (norepinephrine) reuptake. In short term clinical trials of 6 or 8 weeks' duration, nefazodone produced clinical improvements that were significantly greater than those with placebo and similar to those achieved with imipramine, and the selective serotonin reuptake inhibitors (SSRIs) fluoxetine, paroxetine and sertraline. The optimum therapeutic dosage of nefazodone appears to be between 300 and 600 mg/day. Limited long term data suggest that nefazodone is effective in preventing relapse of depression in patients treated for up to 1 year. Analyses of pooled clinical trial results indicate that nefazodone and imipramine produces similar and significant improvements on anxiety- and agitation-related rating scales compared with placebo in patients with major depression. Short term tolerability data indicate that nefazodone has a lower incidence of adverse anticholinergic, antihistaminergic and adrenergic effects than imipramine. Compared with SSRIs, nefazodone causes fewer activating symptoms, adverse gastrointestinal effects (nausea, diarrhoea, anorexia) and adverse effects on sexual function, but is associated with more dizziness, dry mouth, constipation, visual disturbances and confusion. Available data also suggest that nefazodone is not associated with abnormal weight gain, seizures, priapism or significant sleep disruption, and appears to be relatively safe in overdosage. Nefazodone inhibits the cytochrome P450 3A4 isoenzyme and thus has the potential to interact with a number of drugs. Further long term and comparative studies will provide a more accurate assessment of the relative place of nefazodone in the management of major depression. Nonetheless, available data suggest that nefazodone is a worthwhile treatment alternative to tricyclic antidepressants and SSRIs in patients with major depression.
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PMID:Nefazodone. A review of its pharmacology and clinical efficacy in the management of major depression. 921 Oct 88

Jimson weed (Datura stramonium, a member of the Belladonna alkyloid family) is a plant growing naturally in West Virginia and has been used as a home remedy since colonial times. Due to its easy availability and strong anticholinergic properties, teens are using Jimson weed as a drug. Plant parts can be brewed as a tea or chewed, and seed pods, commonly known as "pods" or "thorn apples," can be eaten. Side effects from ingesting jimson weed include tachycardia, dry mouth, dilated pupils, blurred vision, hallucinations, confusion, combative behavior, and difficulty urinating. Severe toxicity has been associated with coma and seizures, although death is rare. Treatment consists of activated charcoal and gastric lavage. Esmolol or other beta-blocker may be indicated to reduce severe sinus tachycardia. Seizures, severe hypertension, severe hallucinations, and life-threatening arrhythmias are indicators for the use of the anticholinesterase inhibitor, Physostigmine. This article reviews the cases of nine teenagers who were treated in hospitals in the Kanawha Valley after ingesting jimson weed. We hope this article will help alert primary care physicians about the abuse of jimson weed and inform health officials about the need to educate teens about the dangers of this plant.
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PMID:The dangers of jimson weed and its abuse by teenagers in the Kanawha Valley of West Virginia. 927 42

During the autumn of 1995, the National Poisons Information Centre was contacted about several cases of poisoning with Jimson weed (Datura stramonium). Five cases are described here. Upon admission to hospital the patients had moderate to severe anticholinergic symptoms, such as mydriasis, sinus tachycardia, agitation, dry mouth, urine retention, fever, hypertension, hallucinations and seizures. Owing to their agitated behaviour, gastrointestinal decontamination was impossible. Repeated doses of physostigmine (2-3 mg) administered intravenously reversed the anticholinergic features without side-effects. In the most severe case, physostigmine was needed for 18 hours (total dose; 25.5 mg). The patients recovered in a day or two, but mydriasis persisted in many cases.
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PMID:[Poisoning with Jimson weed. Five cases treated with physostigmine]. 932 14

Coricidin products seemed to be one of the over-the-counter medications being reportedly abused by adolescents, as observed from the Texas Poison Center Network data. This retrospective chart review investigated the occurrence of abuse, developed a patient profile, and defined the clinical effects resulting from the abuse of Coricidin products. Data collected from the Texas Poison Center Network Toxic Exposure Surveillance System database included human exposures between 1998 and 1999, patients > or = 10y old, intentional use or abuse, and single substance ingestion of I of the tablet formulations of Coricidin. Thirty-three cases from 1998 and 59 cases from 1999 were reviewed. Of these cases, 85% met the inclusion criteria. Of the 7 medications searched, only 4 substances were coded for: Coricidin D, Coricidin D (long acting), Coricidin D (cold, flu & sinus) and Coriciding HBP. These contain a combination of dextromethorphan hydrobromide, chlorpheniramine maleate, phenylpropanolamine hydrochloride, and acetaminophen. Of the 78 cases, 63% were male and 38% were female. The mean age was 14.67 years, 77% being between 13 to 17 years old. Eighteen different symptoms were reported: tachycardia 50%, somnolence 24.4%, mydriasis and hypertension 16.7%, agitation 12.8%, disorientation 10.3%, slurred speech 9%, ataxia 6.4%, vomiting 5.1%, dry mouth and hallucinations 3.9%, tremor 2.6%, and headache, dizziness, syncope, seizure, chest pain, and nystagmus each 1.3%; 12.8% of the calls originated from the school nurse. The incidence of abuse reported increased 60% from 1998 to 1999. This worrisome trend suggests increased abuse of these products.
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PMID:A possible trend suggesting increased abuse from Coricidin exposures reported to the Texas Poison Network: comparing 1998 to 1999. 1204 73

Sustained-release bupropion (bupropion SR) was first launched in the US in 1997 as an aid to smoking cessation and has since been launched in many other countries. Adverse events associated with the use of bupropion SR at the recommended dosage of 150mg twice daily in clinical trials most commonly included insomnia, headache, dry mouth, nausea and anxiety; insomnia and anxiety are also recognised as symptoms of nicotine withdrawal. Only insomnia and dry mouth occurred significantly more frequently with bupropion SR than with placebo. Relative to placebo, no significant changes in mean values for heart rate, blood pressure or routine laboratory parameters have been reported in smokers using bupropion SR alone in clinical trials. When bupropion SR was compared with a nicotine transdermal patch in a clinical trial, insomnia predominated in the bupropion SR group, while dream abnormalities were more common in smokers using the nicotine patch. Bupropion SR and the nicotine transdermal patch in combination can be used safely (with appropriate monitoring) as an aid to smoking cessation. Infrequent but clinically important adverse reactions to bupropion SR include seizures and hypersensitivity reactions: in controlled clinical trials of bupropion SR (300 mg/day), where smokers were carefully screened for risk factors for seizure, the incidence of both seizures and severe hypersensitivity reactions was approximately 0.1% for each event. In order to avoid a risk of seizure of greater than 0.1%, smokers should be screened for predisposing risk factors and adhere to the manufacturer's dosage recommendations (maximum daily dose of 300mg). Thus, bupropion SR is generally well tolerated, as seen by the low discontinuation rate due to an adverse event in clinical trials (6 to 12%). The most common adverse events (insomnia and dry mouth) are generally transient and often resolve quickly without therapeutic intervention; they can be managed if necessary by a reduction in bupropion dose.
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PMID:Tolerability and safety of sustained-release bupropion in the management of smoking cessation. 1210 35

Cigarette dependence is recognised as a life-threatening disorder which can be treated by behavioural support and/or medication. Bupropion hydrochloride sustained-release (Zyban trade mark, GlaxoSmithKline) is licensed in many countries including the US, Canada, UK, Australia and continental Europe to aid smoking cessation. The usual recommended dose is 150 mg b.i.d. taken for 7 - 14 days prior to the quit date, and then 6 - 8 weeks afterwards (figures vary across countries). Evidence from seven double-blind, placebo-controlled, randomised trials shows that it improves success at staying off cigarettes for at least 12 months by 9 - 10 percentage points. Taking into account estimates of subsequent cessation and relapse patterns in treated and untreated smokers, and the improvement in life-expectancy of smokers who manage to stop, the estimated cost/life/year saved from an episode of use of the medication is approximately UK pound 1000 or US$1500. Bupropion has CNS stimulant properties; the common side effects are dry mouth and sleep disturbance. Rare but serious side effects are anaphylactic/hypersensitivity reaction and seizure (both estimated at 1 in a 1000). The drug is contraindicated in patients with hypersensitivity to the drug or its metabolites, any seizure disorder, eating disorder, severe hepatic cirrhosis, history of bipolar disorder or in patients taking monoamine oxidase inhibitors. Extreme caution is advised where there are any predisposing factors that may reduce the seizure threshold. Bupropion sustained-release and nicotine replacement therapies are both considered as first-line treatments to aid smoking cessation. Ideally patients should also enrol in a structured behavioural support programme to boost their chances of success.
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PMID:Bupropion SR for smoking cessation. 1266 16

The advent of bupropion hydrochloride sustained release (Zyban) has heralded a major change in the options available for smoking cessation pharmacotherapy. Bupropion is a selective re-uptake inhibitor of dopamine and noradrenalin which prevents or reduces cravings and other features of nicotine withdrawal. Bupropion is a useful oral and non-nicotine form of pharmacotherapy for smoking cessation. For this review a total of 221 papers were reviewed plus poster presentations. This review examines in detail original clinical trials on efficacy, categorised according to whether they were acute treatment trials in healthy smokers; studies in specific populations such as people with depression, chronic obstructive pulmonary disease (COPD) or cardiovascular disease; or relapse prevention studies. Overall, these studies in varying populations comprising over four thousand subjects, showed bupropion consistently produces a positive effect on smoking cessation outcomes. The evidence highlights the major public health role that bupropion has in smoking cessation. The methodological issues of published clinical trials reporting one year outcomes were examined in detail including: completeness of follow-up; loss to follow-up; intention to treat analysis; blindness of assessment; and validation of smoking status. The review discusses contraindications, adverse effects, dose and overdose, addictive potential, and the role of bupropion in reducing cessation-related weight gain. Bupropion combined with or compared to other pharmacotherapies (nicotine patch; nortriptyline) is considered. Impressive evidence exists for the use of bupropion in smoking cessation among difficult patients who are hard-core smokers such as those with cardiovascular disease, chronic obstructive pulmonary disease (COPD) and depression. Bupropion reduces withdrawal symptoms as well as weight gain and is effective for smoking cessation for people with and without a history of depression or alcoholism. Serious side effects of bupropion use are rare. The major safety issue with bupropion is risk of seizures (estimated at approximately 0.1%) and it should not be prescribed to patients with a current seizure disorder or any history of seizures. In clinical trials of bupropion for smoking cessation no seizures were reported. Allergic reactions occur at a rate of approximately 3% and minor adverse effects are common including dry mouth and insomnia.
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PMID:Review of bupropion for smoking cessation. 1285 Sep 7

Bupropion hydrochloride is a monocyclic antidepressant which is used in a slow-release formulation as a smoking cessation aid. Its side effects include insomnia and dry mouth with seizures occurring in 1 in 1000 patients. In overdose, it can cause tachycardia, conduction defects and convulsions. It is, however, effective in smoking cessation in approximately 20% of patients and may be more effective if combined with nicotine replacement therapy. The key question is whether the risks associated with the drug are justified by the obvious benefits to health from smoking cessation.
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PMID:Zyban-- is there a cause for concern? 1290 29

Citalopram is a highly selective serotonin reuptake inhibitor (SSRI) that has been prescribed to >30 million patients in >70 countries. The purpose of this focused overview is to summarize the data from well-controlled clinical trials and published literature relative to the safety of citalopram in patients with depression and depressive symptoms. This overview is based mainly on 3 sources: (1) data from clinical trials sponsored by Forest Laboratories, (2) published clinical studies, and (3) case reports. Both pharmacokinetic and pharmacodynamic interactions were scrutinized, as were data on special populations and safety concerns. The available data suggest that citalopram 20-60 mg once daily is safe for patients with depression. Few drugs appear to interact with citalopram in a clinically meaningful way. Well-designed short- and long-term trials demonstrate an overall safety/side effect profile consistent with other SSRIs. The more frequent adverse events (nausea, somnolence, dry mouth, increased sweating) are mainly transient, mostly mild to moderate in severity, and observed consistently across studies at rates similar to other SSRIs. Analysis of laboratory values, ECG, and vital signs revealed no unusual findings. Only a small, clinically unimportant reduction in heart rate was observed, similar to that seen with other SSRIs. Citalopram treatment did not increase risk of suicide, overdose, seizure, or arrhythmia. Thus, the pharmacodynamic, pharmacokinetic, and safety profiles of citalopram demonstrate that it is safe for use in adults with depression and depressive symptoms, including the elderly and patients with mild to moderate renal and hepatic disease.
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PMID:Overview of the safety of citalopram. 1456 52


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