The author addresses the issue of using drugs for unapproved indications in the U.S. He comments on the "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical ...
Prolonged Grade 4neutropeniaandthrombocytopeniaoccurred in two pediatric patients withAMLwho received an unapproved formulation of midostaurin in combination with chemotherapy, including anthracyclines, fludarabine, and cytarabine; these two patients were coadministered an azoleantifungal(a strong CYP3A4 inhibitor...
e.g., at night. This represents an incidence of 0.0038 deaths per patient-year. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained deaths in patients with epilepsy not receiving...
¹⁹To attack such figures was to defend an orthodoxeschatology,not to obscure beliefin the End. Similar thingscan be seen 150years later,when StBoniface led the con-demnation of the unapproved holyman Aldebert,‘aprecursor of Antichrist’,who at-tracted people by offering quick absolution ...
U.S. lets drugmakers advise doctors on unapproved usesL. RichwineThe American Journal of Managed Care
Manufacturer's warning regard- ing unapproved uses of misoprostol. N Engl J Med 2001;344:61Friedman MA. Manufacturer's warning regarding unapproved uses of misoprostol. N Engl J Med. 2001;344:61.Friedman M. Manufacturer's Warning Regarding unapproved uses of Misoprostol. N Eng J Med 2001:344...
unapproved uses. When prescribing NEURONTIN, carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., self-dose escalation and drug-seeking behavior). The abuse potential of gabapentin has not been evaluated in human ...
Avoid concomitant use of strong CYP3A4 inducers by use of an alternate concomitant medication with no or minimal enzyme induction potential. VOTRIENT is not recommended in patients who cannot avoid chronic use of strong CYP3A4 inducers [seeDRUG INTERACTIONS]. ...
Food and Drug Administration (FDA) on the distribution uses of unapproved prescription drugs and medical devices to physicians and journals referencing such uses. The agency attempted to prevent the discussion of the uses in case of persuasive data in medical textbooks. FDA retained the right to ...
Proposal published on dissemination of information on unapproved uses.States the United States Food and Drug Administration (FDA) published a proposed rule for implementing provisions of the Modernization Act of 1997.NightingaleStuartL.JAMA: Journal of the American Medical Association...