International journal of impotence research
-
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.
-
Int. J. Impot. Res. · Mar 2008
Comparative Study Clinical TrialEfficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men.
The study objective was to evaluate the efficacy of changing testosterone gel preparations among suboptimally responsive hypogonadal men. The records of all hypogonadal men on gel (Testim or Androgel) testosterone replacement therapy (TRT) were reviewed to identify men who underwent a brand substitution in gel TRT due to initial suboptimal response. Total and free serum testosterone levels and the presence of hypogonadal symptoms (ADAM) were compared pre- and post-gel substitution. ⋯ A change in testosterone gel preparation among initially unresponsive hypogonadal men is justified prior to abandoning or considering more invasive TRT. Changing from Androgel to Testim offers hypogonadal men the potential for improved clinical and biochemical responsiveness. Changing from Testim to Androgel is indicated to eliminate or minimize unwanted side effects.