Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

This paper summarizes all postmarketing safety surveillance data collected by Solvay Pharmaceuticals, Inc. (Marietta, Georgia), between 1989 and 1996 for Estratest and Estratest HS (half-strength). These oral esterified estrogens--methyltestosterone combination products have been marketed in the United States since 1964 for the treatment of moderate-to-severe vasomotor symptoms associated with menopause in patients whose symptoms have not been relieved by estrogens alone. Between 1989 and 1996, more than 1 million woman-years of exposure occurred. The safety profile contained in this paper is based on a cumulative total of 568 individual cases comprising 863 adverse events (AEs). The proportions of AEs associated with the use of Estratest (575 events; 66.6%) and Estratest HS (288 events; 33.4%) were commensurate with the proportions of individual reports of adverse experiences for the two formulations (369 reports [65.0%] and 199 reports [35.0%], respectively). The rank order and percentage of types of AEs reported were also similar. The cumulative volume of reports was relatively low given the extent of exposure. Despite the limitations inherent in spontaneous postmarketing surveillance, the safety profile derived from this assessment does not indicate a significant safety concern with Estratest or Estratest HS. No deaths were reported, and no adverse findings indicative of the need for more comprehensive surveillance or concern on the part of the medical community or consumers were observed. Reports of cancer, cardiovascular disease, thromboembolic phenomena, and hepatic dysfunction were few and were assessed as not related to treatment with Estratest or Estratest HS; reports of drug overdose, drug-drug interaction, and birth defects were rare (4 of 863 events; 0.5%). The most commonly reported AEs were those known to be associated with estrogen therapy (weight gain, headache, nausea, and vasodilatation) and androgen treatment (alopecia, acne, and hirsutism). Twenty-three (4.0%) of the 568 cases reported had at least one event that was regarded as serious, and 53 (6.1%) of the total 863 AEs were regarded as serious. The findings indicate that Estratest and Estratest HS are safe when used as directed and that the marginal increase in risk associated with androgen coadministration can be managed with appropriate patient selection and monitoring, as stated in the package insert for these compounds.
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PMID:Safety surveillance of esterified estrogens-methyltestosterone (Estratest and Estratest HS) replacement therapy in the United States. 938 94

The performance of the monthly injectable contraceptive, Cyclofem, was evaluated in an introductory trial involving 3183 women recruited from family planning centers in Brazil, Chile, Colombia, and Peru. A total of 29,676 women-months of use were accumulated during up to 2 years of follow-up. No pregnancies occurred during the study period. Discontinuation rates per 100 women in the first year ranged from 3.4 in Brazil to 8.1 in Colombia for amenorrhea and from 5.1 in Chile to 9.2 in Brazil for menstrual disturbances. The discontinuation rate for other medical reasons (primarily headache, weight gain, and acne) ranged from 7.8 in Brazil to 26.3 in Colombia and for personal reasons from 17.2 in Chile to 23.5 in Brazil. First-year continuation rates ranged from 42.3 in Colombia to 52.0 in Chile. In the second year of use, continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. Upon receiving these results, national regulatory authorities in the 4 participating countries approved Cyclofem registration. Acceptance of injectable contraception, which currently entails administration of the method by a service provider and travel to a clinic, could be improved in developing countries by training in self-administration.
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PMID:Introductory study of the once-a-month, injectable contraceptive Cyclofem in Brazil, Chile, Colombia, and Peru. 949 68

The contraceptive safety and efficacy of long-term use of the oral contraceptive Belara (30 mcg ethinyl estradiol and 2 mg chlormadinone acetate) were assessed in an open, noncontrolled phase III study. Of particular interest was the effect of the anti-androgenic activity of this formulation on clinical signs of androgenization. Belara was taken by 1655 German women (mean age, 25.9 years), for a total of 22,337 cycles. A total of 12 pregnancies occurred, yielding a theoretical Pearl index of 0.269 (95% confidence interval, 0.109-0.600). No withdrawal bleeding occurred in 1655 cycles (7.4%), while spotting was documented in 2565 (11.5%) and breakthrough bleeding in 786 (3.5%). After 12 cycles of use, acne on the face/neck improved in 64.1% of affected women and completely disappeared in 53.4%. Seborrhea improved after 12 cycles in 67.9% of affected women and was cured in 58.0%. Side effects included headache (37.4%), nausea (23.1%), breast tenderness (21.7%), and vaginal discharge (19.4%). Of the 62 serious adverse events reported by 59 women, only the 2 cases of deep venous thrombosis could be linked to Belara use. Overall, these findings suggest that Belara is a well-tolerated oral contraceptive with minor side effects comparable to those associated with use of other low-dose pills.
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PMID:Efficacy and safety of the new antiandrogenic oral contraceptive Belara. 958 37

Side effects are a common occurrence in the use of subdermal contraceptive implants (Norplant); approximately 70% to 80% of women using the device report abnormal uterine bleeding, headaches, acne, mastalgia, nervousness, appetite changes, and weight gain. Local implant site reactions range from 0.4% to 4.7%, with pain being the most common. Other insertion site complications include infection and implant expulsion. Only three cases have been described in the literature concerning implant site-related neuropathy, involving the sensory branch of the musculocutaneous nerve (lateral cutaneous nerve) in two cases and the antebrachial cutaneous nerve in the third case. We believe our report is the first case of an axonal loosing motor and sensory ulnar neuropathy associated with the removal of a subdermal contraceptive implant (Norplant). We review insertion site complications and their most likely causes. Also, we discuss alternative removal techniques for difficult-to-remove implants.
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PMID:Ulnar neuropathy associated with subdermal contraceptive implant. 974 65

Since 1986, Thailand's National Family Planning Program has included the Norplant 6-capsule implant system. The present paper reports the results of a 3-year Phase III clinical trial of the newly developed 2-rod system (Norplant-2). A total of 140 women (mean age, 29 years), in Bangkok, were enrolled and 103 women completed 3 years of method use. The continuation rates at 1, 2, and 3 years were 93.9%, 89.2%, and 82.8%, respectively. There were no accidental pregnancies during the 3-year study period. The 3-year cumulative termination rate was 7.2% for personal reasons (e.g., divorce, husband underwent vasectomy), 4.6% for medical reasons (e.g., acne, headache, pain at the implant site), and 3.8% for menstrual irregularities. A total of 125 acceptors underwent Norplant removal either during or at the end of the study period. The incidence of difficult removals was 8%. In most of these cases, the difficulty involved rod breakage. The average time required for removal was 3.4 minutes. These findings indicate that Norplant-2 is a safe, effective, acceptable contraceptive method appropriate for inclusion in Thailand's family planning program. The potential for fragmentation of the rods during removal requires careful monitoring, however.
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PMID:Experience of Thai women in Bangkok with Norplant-2 implants. 986 3

This paper presents the 5-year randomized study on the performance of levonorgestrel rod (LNG) and Norplant contraceptive implants in 1198 women in 7 centers. In the first 4 years, no pregnancies occurred. At 5 years, the cumulative pregnancy rate was 1/100 users or less for each regimen. Annual discontinuation rates averaged 11-12/100 users, corresponding to a 5-year continuation rate of 55.1/100 for rods and 53.0/100 for capsules. Mean annual discontinuation rates for menstrual disturbances were 3.5/100 for rod and 4.2/100 for capsule implants. Reasons for discontinuation of use were vaginal spotting or bleeding, irregular bleeding, headache, weight gain and acne. Proportional hazard regression models established that family formation variables, age, parity, and desire for another child, recorded at admission, significantly affected discontinuation rates for major decrement categories and for all reasons combined. Mean rod removal time was half that of Norplant. Complications of rod removal were at a lower rate. This study concludes that there is an extremely high contraceptive effectiveness for LNG rod and Norplant implants; however, LNG rod implants were more preferable than Norplant for its relative ease in removal.
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PMID:The performance of levonorgestrel rod and Norplant contraceptive implants: a 5 year randomized study. 988 17

This integrated analysis evaluates nonmenstrual adverse events, blood pressure, and body weight changes during the use of the single-rod etonogestrel-containing contraceptive implant, Implanon; these aspects are compared for Implanon and Norplant, the six-capsule implant containing levonorgestrel. Overall, 47% of Implanon users had drug-related adverse events, whereas in the comparative studies the figure for those using Implanon (61%) was slightly lower than that for Norplant users (69%). In all Implanon studies, 12 of 1716 women (0.7%) were affected by serious adverse events that were considered drug related. In comparative studies three of the 689 Implanon users (0.4%) and one of 689 Norplant users (0.1%) had such experiences. The most frequently reported drug-related adverse events were acne, breast pain, headache and weight gain. The adverse events that most often caused discontinuation of Implanon were weight gain and acne. The development or aggravation of acne was a frequent adverse event (in 18.5% of Implanon and 22.3% of Norplant users in the comparative studies) but individual studies indicated that there were also many subjects whose acne improved during implant use. There were gradual increases in body weight over time but these may be only partly attributable to implant use and partly attributable to normal increases over time.
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PMID:An integrated analysis of nonmenstrual adverse events with Implanon. 1550 85

Prolactinomas are the most common pituitary tumors. Hyperprolactinemia is characterized by increased production of prolactin, often leading to reproductive dysfunction and galactorrhea. Prolactinomas may also cause male-factor infertility by producing hypogonadism. In addition, if large, they can produce neurologic symptoms by mass effect in the sellar area. The diagnostic evaluation first requires exclusion of other causes of hyperprolactinemia, such as pregnancy, primary hypothyroidism, numerous medications, and miscellaneous causes. The second step in the diagnostic evaluation is to perform a head scan, preferably an MRI. This is essential in order to exclude a "pseudoprolactinoma" which would require surgery. Following diagnostic evaluation, the next step is to determine whether a patient with hyperprolactinemia has an indication for therapy, such as a macroprolactinoma (tumor >1 cm), hypogonadism (risk of osteoporosis), infertility, significant galactorrhea, acne, hirsutism, or headache. The treatment of choice for nearly all patients with hyperprolactinemic disorders is medical. In most cases, dopamine agonists (bromocriptine, pergolide, cabergoline) are extremely effective in lowering serum prolactin, restoring gonadal function, decreasing tumor size, and improving visual fields. The main limitation is side effects, particularly nausea or orthostatic dizziness. The newest dopamine agonist, cabergoline, can be given just once or twice a week, is more effective in normalizing prolactin and restoring menses than bromocriptine, and is significantly better tolerated. However, it is not yet recommended as first-line therapy for patients seeking fertility, because adequate safety data in pregnancy are not available. For the infrequent patient unable to tolerate, or resistant to, medical therapy, neurosurgical transsphenoidal resection may be necessary, particularly if the patient has a large lesion jeopardizing the optic chiasm. Hyperprolactinemia is a rewarding disorder to manage because patients typically respond well to medication, with restoration of menses and fertility.
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PMID:Hyperprolactinemia. 1033 64

A 15-year-old girl, who had been treated with minocyclin for acne for 2 months, was admitted for investigation of headache, nausea and papilledema. A space-occupying lesion was ruled out by computerized brain tomography. The diagnosis of benign intracranial pressure (pseudo-tumor cerebri) was made because of elevated cerebrospinal fluid pressure with normal biochemistry and cytology. Tetracyclines, especially minocyclin, commonly used for treating acne in adolescents, can cause benign intracranial pressure.
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PMID:[Benign intracranial hypertension following minocycline]. 1090 33

Despite limited understanding of therapeutic aetiopathogenesis of ulcerative colitis and Crohn's disease, there is a strong evidence base for the efficacy of pharmacological and biological therapies. It is equally important to recognise toxicity of the medical armamentarium for inflammatory bowel disease (IBD). Sulfasalazine consists of sulfapyridine linked to 5-aminosalicylic acid (5-ASA) via an azo bond. Common adverse effects related to sulfapyridine 'intolerance' include headache, nausea, anorexia, and malaise. Other allergic or toxic adverse effects include fever, rash, haemolytic anaemia, hepatitis, pancreatitis, paradoxical worsening of colitis, and reversible sperm abnormalities. The newer 5-ASA agents were developed to deliver the active ingredient of sulfasalazine while minimising adverse effects. Adverse effects are infrequent but may include nausea, dyspepsia and headache. Olsalazine may cause a secretory diarrhoea. Uncommon hypersensitivity reactions, including worsening of colitis, pancreatitis, pericarditis and nephritis, have also been reported. Corticosteroids are commonly prescribed for treatment of moderate to severe IBD. Despite short term efficacy, corticosteroids have numerous adverse effects that preclude their long term use. Adverse effects include acne, fluid retention, fat redistribution, hypertension, hyperglycaemia, psycho-neurological disturbances, cataracts, adrenal suppression, growth failure in children, and osteonecrosis. Newer corticosteroid preparations offer potential for targeted therapy and less corticosteroid-related adverse effects. Azathioprine and mercaptopurine are associated with pancreatitis in 3 to 15% of patients that resolves upon drug cessation. Bone marrow suppression is dose related and may be delayed. The adverse effects of methotrexate include nausea, leucopenia and, rarely, hypersensitivity pneumonia or hepatic fibrosis. Common adverse effects of cyclosporin include nephrotoxicity, hypertension, headache, gingival hyperplasia, hyperkalaemia, paresthesias, and tremors. These adverse effects usually abate with dose reduction or cessation of therapy. Seizures and opportunistic infections have also been reported. Antibacterials are commonly employed as primary therapy for Crohn's disease. Common adverse effects of metronidazole include nausea and a metallic taste. Peripheral neuropathy can occur with prolonged administration. Ciprofloxacin and other antibacterials may be beneficial in those intolerant to metronidazole. Newer immunosuppressive agents previously reserved for transplant recipients are under investigation for IBD. Tacrolimus has an adverse effect profile similar to cyclosporin, and may cause renal insufficiency. Mycophenolate mofetil, a purine synthesis inhibitor, has primarily gastrointestinal adverse effects. Biological agents targeting specific sites in the immunoinflammatory cascade are now available to treat IBD. Infliximab, a chimeric antibody targeting tumour necrosis factor-or has been well tolerated in clinical trials and early postmarketing experience. Additional trials are needed to assess long term adverse effects.
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PMID:Comparative tolerability of treatments for inflammatory bowel disease. 1108 48


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