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Query: UMLS:C0018681 (headache)
56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Safety and toleration of oral trovafloxacin has been assessed in Phase III trials in patients with acute lower respiratory tract infections. Patients were treated orally with either trovafloxacin 100 or 200 mg (n=881) or a comparator (500 or 1000 mg amoxicillin, or 625 mg amoxicillin/clavulanic acid; n = 593). Adverse events were recorded in 112 (12.7%) trovafloxacin- and 74 (12.5%) comparator-treated patients. Frequency of effects on the autonomic nervous, musculoskeletal, respiratory, special senses, urinary and reproductive systems was <1%. Photosensitivity reactions were not reported in trovafloxacin-treated patients. Central or peripheral nervous system adverse effects (headache and dizziness) were slightly more common in trovafloxacin-treated patients (4.4% vs 1.9%). Patients treated with comparators experienced gastrointestinal events more frequently (6.1% vs 8.3%). Comparable incidences of adverse events were reported in patients > or = 65-years-old. Most events were mild to moderate in severity. Treatment was discontinued because of an adverse event in 18 (2%) trovafloxacin- and four (0.7%) comparator-treated patients. Despite the high prevalence of risk factors, serious adverse events were rare and the mortality rate over the 35-day study period was low: trovafloxacin 0.8%, comparator agents 1.5%. Laboratory test abnormalities were recorded in less than 1% of patients in either treatment group.
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PMID:Safety of trovafloxacin in treatment of lower respiratory tract infections. 975 92

The safety profile of grepafloxacin has been characterized in a number of preclinical and clinical studies. Preclinical investigations have shown that its toxicologic profile is similar to that of other fluoroquinolones, and phase I studies in humans have confirmed these data. A photosensitivity study demonstrated equivalence with ciprofloxacin, and a study in elderly patients taking the highest clinical dose of grepafloxacin indicated that prolongation of the QTc interval by grepafloxacin was less than 2 ms, 15 times less than that observed in a study of erythromycin. In phase II and III clinical investigations conducted in the United States and the United Kingdom, safety data have been gathered from more than 3000 patients with either community-acquired pneumonia or acute bacterial exacerbations of chronic bronchitis. The most common adverse events with grepafloxacin 400 or 600 mg were gastrointestinal, such as nausea, vomiting, and diarrhea. The frequency of these adverse events was similar to that seen with ciprofloxacin. Significantly more patients reported a mild, unpleasant metallic taste with grepafloxacin than with ciprofloxacin, but <1% of patients withdrew from therapy because of this. Headache was observed significantly more often in ciprofloxacin-treated patients than in grepafloxacin-treated patients. Recent postmarketing data confirm the good tolerability and safety profile of grepafloxacin. These data, from a case-report study of more than 9000 patients in Germany, demonstrated that only 2.3% of patients reported adverse events when grepafloxacin was used in routine clinical practice. The most frequently reported events were nausea (0.8%) and gastrointestinal symptoms (0.4%). Dizziness was reported by only 0.3% of patients, and only 4 patients (0.04%) reported photosensitization. Adverse events did not appear to be either dose dependent or related to diagnosis. More than 400,000 patients world-wide have received grepafloxacin treatment. No new safety issues have arisen from the spontaneous-report data and, with the exception of rare reports of an unpleasant taste, the most commonly reported events have been the same as those seen in clinical studies. These data support grepafloxacin as a well-tolerated fluoroquinolone suitable for the treatment of community-acquired respiratory tract infections.
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PMID:Grepafloxacin: a review of its safety profile based on clinical trials and postmarketing surveillance. 1009 Apr 25

Urinary tract infection (UTI) is a common illness, with > or =30% of all women experiencing a UTI during their lifetime. Less than a decade ago, the standard therapy for acute uncomplicated UTIs involved treatment with > or =7 days of an antibacterial agent, but recent studies using a variety of newly introduced antibiotics, including the fluoroquinolones, have demonstrated that a 1- to 5-day treatment regimen can be equally effective. This randomized, double-masked, multicenter study was conducted to compare the efficacy and tolerability of a single dose of sparfloxacin with those of a 3-day regimen of sparfloxacin and a 7-day regimen of ciprofloxacin in the treatment of women with community-acquired acute uncomplicated urinary tract infection. A total of 1175 women were enrolled; 395 received sparfloxacin as a single 400-mg dose on day 1, 394 received sparfloxacin as a 400-mg loading dose on day 1 followed by 200 mg once daily for 2 additional days, and 386 received ciprofloxacin 250 mg twice daily for 7 days. Patients were comparable with respect to demographic characteristics and underlying conditions. A total of 954 patients were clinically assessable; 490 of these were also bacteriologically assessable. All patients treated were included in the tolerability analysis. Escherichia coli (75.4%), Klebsiella pneumoniae (4.9%), Enterococcus faecalis (4.6%), and Staphylococcus saprophyticus (4.1%) were the most commonly isolated organisms. In the all-treated population, clinical success was achieved 5 to 9 days after therapy in 91.8%, 92.2%, and 91.6% of patients in the single-dose sparfloxacin, 3-day sparfloxacin, and 7-day ciprofloxacin groups, respectively; bacteriologic success was observed in 91.7%, 92.6%, and 96.6% of those in the 3 groups. Sustained clinical success rates 4 to 6 weeks after therapy were 76.6%, 80.2%, and 79.5% in the single-dose sparfloxacin, 3-day sparfloxacin, and 7-day ciprofloxacin groups, respectively; sustained bacteriologic success rates were 80.7%, 90.1%, and 92.6%. The most common adverse events were nausea, headache, vaginal thrush, dizziness, and diarrhea; >92% of adverse events were mild or moderate in severity. The 2 drugs had comparable frequencies of adverse events, except for photosensitivity, which occurred in 3.3% of the 3-day sparfloxacin group, 1.3% of the single-dose sparfloxacin group, and 0.3% of the ciprofloxacin group (P = 0.005). The 3-day sparfloxacin regimen was effective and well tolerated. The initial response to single-dose sparfloxacin treatment was comparable to the response to the other 2 regimens, but the single-dose regimen proved less effective over time, with higher rates of clinical recurrence and bacteriologic relapse. Sparfloxacin provides an alternative to ciprofloxacin for patients with acute uncomplicated urinary tract infection who are not at risk for photosensitivity reactions or adverse events associated with a prolonged corrected QT interval.
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PMID:Comparison of sparfloxacin and ciprofloxacin in the treatment of community-acquired acute uncomplicated urinary tract infection in women. Sparfloxacin Multicenter Uncomplicated Urinary Tract Infection Study Group. 1044 Jun 21

Photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA)-induced protoporphyrin IX (PpIX) may have a role in the treatment of dysplastic Barrett's esophagus. Before ALA-induced PDT can be used clinically, optimum treatment parameters must be established. In this study of 35 patients, the issues of drug dosage, time interval between drug and light delivery and side effects of oral ALA administration are addressed. Spectrofluorometric analysis of tissue samples demonstrates that oral ALA administration induces porphyrin accumulation in esophageal tissues, with maximum levels at 4-6 h. High-performance liquid chromatography confirms the identity of this porphyrin as PpIX, and fluorescence microscopy analysis demonstrates that it preferentially accumulates in the esophageal mucosa, rather than in the underlying stroma. Side effects of ALA administration included malaise, headache, photosensitivity, alopecia, transient derangement of liver function, nausea and vomiting. Fewer side effects and less hepatic toxicity was seen with 30 mg/kg than 50 mg/kg ALA. In conclusion, oral ALA administration induces preferential PpIX accumulation in the esophageal mucosa, with peak PpIX fluorescence noted at 4 h and minimal systemic toxicity at a dose of 30 mg/kg.
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PMID:5-Aminolevulinic acid photosensitization of dysplastic Barrett's esophagus: a pharmacokinetic study. 1054 61

Photosensitivity is a typical feature of photosensitive epilepsy which is usually considered a form of idiopathic generalized epilepsy. Partial seizures featuring visual symptoms are rarely reported in photosensitive epilepsy. In this study, we describe 13 neurologically normal patients in whom daytime seizures were always induced by television and began with elementary visual hallucinations, followed frequently by vomiting, headache and then secondary generalization. Three patients additionally reported nocturnal seizures, which have not been described in previous studies. Two of these latter patients had generalized tonic-clonic seizures, the other always awoke from sleep and could describe typical visual hallucinations at the beginning of the seizure. EEG features included normal background activity and occipital spikes or spike-waves in all but two patients. Eight patients also showed generalized epileptiform activity during intermittent photic stimulation. Seizure frequency was low in all. Apart from two patients, who refused treatment, all patients received antiepileptic drugs. Only one patient continued to have rare seizures after treatment; in the others seizure control was achieved with monotherapy. We conclude that reflex occipital lobe epilepsy is an idiopathic form of the benign partial epilepsies, which may overlap with one another.
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PMID:Reflex occipital lobe epilepsy. 1098 3

This paper reviews the safety data for levofloxacin utilizing reports from clinical and post-marketing surveillance trials. The side effect incidence rates are 1.3% for nausea, 0.1% for anxiety, 0.3% for insomnia, and 0.1% for headache. No levofloxacin-related adverse events were reported at a rate higher than 1.3%, and most were lower. Four clinical trials were reported. Levofloxacin achieved superior clinical and microbiological results compared to ceftriaxone/macrolide combination, and was better tolerated. Results comparing IV azithromycin plus ceftriaxone versus 500 mg levofloxacin in hospitalised CAP demonstrated that levofloxacin performed better, with more adverse events associated with the comparators (levofloxacin 5.3%, comparators 9.3%). High-dose levofloxacin (750 mg) was also evaluated and found to be well tolerated. Surveillance data reported low ADR rates for levofloxacin: nausea 0.8%, rash 0.5%, abdominal pain 0.4%, and diarrhoea, dizziness, and vomiting 0.3%. Worldwide and US surveillance data confirmed that tendon rupture occurred in less than 4 per million prescriptions, taste perversion in less than 3 per million, convulsions in 2 per million, and photosensitivity, hepatitis, hepatic failure, QT prolongation, torsade de pointes or empyema all in less than 1 per million.
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PMID:Latest industry information on the safety profile of levofloxacin in the US. 1154 87

Amlodipine is a potent peripheral and coronary vasodilator with high selectivity for vascular smooth muscle, and is widely used in mild to moderate hypertension, chronic stable angina and vasospastic angina. Its most prevalent side effects are peripheral edema, flushing and headache. Cutaneous adverse reactions associated with amlodipine have been rarely reported. Herein, a male patient is described to develop oral mucosal and cutaneous hyperpigmentation one year after starting amlodipine, which became more noticeable with time. Although cutaneous hyperpigmentation was most prominent on the photoexposed areas, there was no history of previous photosensitivity, pruritus or flushing. To our knowledge, no case of oral and cutaneous hyperpigmentation associated with amlodipine has been formally reported up to date.
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PMID:Amlodipine associated hyperpigmentation. 1475 92

Voriconazole, a second-generation triazole, has recently been approved by the Food and Drug Administration (FDA) to treat invasive aspergillosis and refractory infections with Scedosporium apiospermum or Fusarium spp. The reported side-effects of voriconazole include visual changes, headaches, elevated hepatic enzymes, Steven-Johnson syndrome, toxic epidermal necrolysis, chelitis, photosensitivity, discoid lupus erythematosus and anaphylactoid infusion reactions. Pseudoporphyria was first described in association with nalidixic acid. It has the same clinical and histologic features as porphyria cutanea tarda (PCT) but is distinguished by normal porphyrin levels in the serum, urine and stool. We present the case of a patient who developed pseudoporphyria after receiving treatment with voriconazole.
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PMID:Pseudoporphyria as a result of voriconazole use: a case report. 1718 62

Clinical and paraclinical data (visual stress tests, electroencephalographic and cerebrovascular photic driving, visual evoked potentials) demonstrate that the concept of photosensitive headache is fully justified. The interictal hallmark of photosensitive cephalalgic patients is potentiation (or sensitization) instead of habituation. The aetiopathogenic mechanisms of photosensitive headache associate hypofunction of the biological clock and magnesium depletion. The new concept of headache due to photosensitive magnesium depletion seems justified. It appears logical to add the treatments of magnesium depletion and of photosensitivity to classical treatment of headache. Prophylactic magnesium treatment relies on atoxic nutritional magnesium supplementation in case of primary magnesium deficiency. Pharmacological doses of parenteral magnesium may be used but may induce toxicity. Therefore it is necessary to know the therapeutic index of magnesium compound used: the larger its value, the greater the safety margin. Treatment of photosensitivity uses various types of <<darkness therapies>>: darkness therapy through physiologic, psychotherapic, physiotherapic, pharmacologic stimulating techniques and substitutive darkness therapy through palliative treatment. Melatonin is only a partial substitutive treatment of photosensitivity. A new model of photosensitive magnesium depletion with potentiation should be a useful tool for discriminating the most efficient gent.
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PMID:Headache due to photosensitive magnesium depletion. 1610 Aug 49

The occipital lobe involvement in the pathogenesis of the migraine aura, frequent occurrence of photogenic stimuli as the provoking factors of a migraine attack, still unsatisfactory explanation of the relation between migraine and epilepsy have drawn our attention to the photosensitivity in the idiopathic headaches, particularly in the developmental period. Photosensitivity is detected in EEG as a paroxysmal response to intermittent photic stimulation. This reaction called a photoparoxysmal response (PPR) has to be regarded as genetically determined EEG-symptom and occurs in 1.3-1.4% of healthy individuals aged 6-18. The aim of the study was to compare the frequency and identify the type of PPR in idiopathic headaches in children: with migraine with aura, without aura and with tension-type headache as well as to find the possible correlation between PPR and migraine photogenic triggering factors in children and adolescents aged 7-18. In years 2001-2003 263 EEG records were performed in patients hospitalized because of idiopathic headaches: 77 with the diagnosis of migraine with aura, 112 - migraine without aura, 74--in tension-type headache. The Fisher exact test was used to compare the number of patients with positive PPR and those with photogenic triggering factors of a migraine attack. The frequency of PPR did not differ significantly in three types of idiopathic headaches and accounts for 7.8% in migraine with aura, 8.9%--migraine without aura and 6.7%--in tension-type headache. PPR was most frequent (17.6%) in a group of children under 12 years of age with migraine with aura. In the migraine with aura PPR had the form of the general paroxysmal of the spike, polyspike and wave in 11.8%, localized changes in the temporal-parietal-occipital region only in 5.9%. In 7/17 patients with migraine and PPR, photogenic stimuli were most frequent provoking factors for the migraine attack (in controls without PPR 10/100) (p<0,01). Frequent coexistence of PPR and photogenic provocation of the migraine attack in children and adolescents supports the theory about general cortical hyperexcitability in migraine.
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PMID:[Photosensitivity in children with idiopathic headaches]. 1641 65


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