International journal of impotence research
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Int. J. Impot. Res. · Mar 2008
Review'Off-label' drug use: an FDA regulatory term, not a negative implication of its medical use.
As physicians continue to prescribe more and more drugs, plaintiff's attorneys in the wake of tort reform are attempting to carve out or create informed consent cases based on the Food and Drug Administration's (FDA) labeling requirements and the doctors' communications with their patients as it relates to those requirements. The theory of tort litigation revolves around whether the doctor disclosed to his patient the fact that he prescribed a drug in an 'off-label' manner, or for a purpose not approved by the FDA's testing process. This article argues that the doctor's decision to inform the patient of the 'off-label' status of the prescription is not relevant to the physician's standard of care for an informed consent case. ⋯ In fact, prescribing medication in an 'off-label' manner can constitute the standard of care in many cases. Third, a doctor's duty is to practice medicine and treat his patient, not inform the patient of the FDA's non-medically related labeling. Therefore, doctors should not be branded with the additional duty of disclosing non-pertinent information, such as the FDA's medically irrelevant distinction, to their patients.
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Pelvic surgeries are among the most common causes of organic sexual dysfunction in men and women. The impact of nerve-sparing surgery on potency has been well documented in radical prostatectomy. However, its impact on potency needs to be evaluated in other pelvic surgeries. ⋯ Currently available treatment options for the female sexual dysfunction include estrogens, androgens, phosphodiesterase inhibitors, and dopamine receptor antagonists. Initial reports regarding the role of early rehabilitation are encouraging and may become the part of routine practice in the management of ED after pelvic surgery. In this article, we summarize the sexual dysfunction following pelvic surgeries and their management.
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Priapism, in which penile erection persists in the absence of sexual excitation, is an enigmatic yet devastating erectile disorder. Current endeavors to manage the disorder suffer from a poor fundamental knowledge of the etiology and pathogenesis of priapism. These endeavors have remained essentially reactive, which commonly fail to avert its pathological consequences of erectile tissue damage and erectile disability, not to mention its psychological toll. ⋯ In addition, consistent with the hypothesis that dysregulative physiology of penile erection accounts for some presentations of priapism, several plausible molecular mechanisms influencing the functional state of the erectile tissue are discussed. Current progress in the field suggests prevention possibilities using androgenic suppressive therapy, adrenergic agonist therapies, and effectors of the nitric oxide-dependent erection regulatory pathway in the penis. New ideas for prevention may emerge from targeting molecular mechanisms involved in regulating erectile tissue function.
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Hypogonadism is an uncommon cause of erectile dysfunction. Unfortunately, hypogonadal states in adult males are difficult to diagnose on purely clinical grounds and it is necessary to seek biochemical support. The simplest way to establish the diagnosis of hypogonadism is by determination of serum testosterone levels. ⋯ In the absence of an adequate response, co-morbidities should be diligently sought out. In the absence of reliable guidelines for androgen administration to patients with erectile failure, a set of recommendations are provided. International Journal of Impotence Research (2000) 12, Suppl 4, S112-S118.
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Int. J. Impot. Res. · Mar 2000
ReviewOral phentolamine: an alpha-1, alpha-2 adrenergic antagonist for the treatment of erectile dysfunction.
Phentolamine mesylate is an alpha-1 and alpha-2 selective adrenergic receptor antagonist which has undergone clinical trials for erectile dysfunction treatment. Biochemical and physiological studies in human erectile tissue have revealed a high affinity of phentolamine for alpha-1 and alpha-2 adrenergic receptors. Based on pharmacokinetic studies, it is suggested that 30-40 min following oral ingestion of 40 or 80 mg of phentolamine (Vasomax), the mean plasma phentolamine concentrations are sufficient to occupy the alpha-1 and -2 adrenergic receptors in erectile tissue and thereby result in inhibition of adrenergic-mediated physiologic activity. ⋯ There were no severe adverse events. At 40 mg, 7.7% experienced rhinitis and fewer than 3.1% experienced any other side effect of treatment. Phentolamine is safe, well tolerated and efficacious for the treatment of erectile dysfunction.