“…21 Interestingly, dextromethorphan hydrobromide is typically used as a nonnarcotic antitussive in cough medicines, 22 and quinidine sulphate is used as an antiarrhythmic. 23 Although the EMA guidelines stating that monotherapy comparisons should be conducted in the clinical trial, Nuedexta was authorized per a trial comparing the combination to placebo 21 and for the reasoning of improving a patient’s quality of life. 21 Another example includes the lidocaine/prilocaine Plethora product developed for premature ejaculation, which was authorized without a comparison to lidocaine and prilocaine on their own.…”
With off-label use, profitability, and reimbursement threatening the development of FDCs, it is the patients who end up suffering the most. The industry, regulatory bodies, and patients need to unite for the successful development of new FDCs.
“…21 Interestingly, dextromethorphan hydrobromide is typically used as a nonnarcotic antitussive in cough medicines, 22 and quinidine sulphate is used as an antiarrhythmic. 23 Although the EMA guidelines stating that monotherapy comparisons should be conducted in the clinical trial, Nuedexta was authorized per a trial comparing the combination to placebo 21 and for the reasoning of improving a patient’s quality of life. 21 Another example includes the lidocaine/prilocaine Plethora product developed for premature ejaculation, which was authorized without a comparison to lidocaine and prilocaine on their own.…”
With off-label use, profitability, and reimbursement threatening the development of FDCs, it is the patients who end up suffering the most. The industry, regulatory bodies, and patients need to unite for the successful development of new FDCs.
“…In adults, paroxysmal ventricular tachycardia has been observed in association with nearly all types of heart disease 33 as well as in persons with no evidence of cardiac abnormality other than the bouts of rapid heart action. 34 Although a few examples of supraventricular tachycardia associated with congenital cardiac anomalies have been recorded 35 and Faxen 36 reported that Bjerlov had observed a case of paroxysmal tachycardia in a patient with bundle branch block and a congenital septal defect, a review of the literature has disclosed no instance of ventricular tachy¬ cardia occurring in a patient with congenital heart disease, and case 1 is believed to be the first recorded example of such an association. Inas¬ much as this patient had an interventricular septal defect, it is inter¬ esting to note that in some instances of ventricular tachycardia occurring in patients with myocardial infarction the lesions were found to involve the septum.37…”
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