Promoting Amphetamines for Over-Eating - What Could Possibly Go Wrong?

In this study, about 5% of patients given any dosage of Vyvanse had to discontinue its use because of adverse effects.  3/196 patients initially randomized to Vyvanse had serious adverse effects, and one patient died, apparently of an amphetamine overdose.  Oddly, the article declared that the one death, due to methamphetamine overdose, was thought by a study investigator not to be related to treatment with another amphetamine, lisdexamfetamine.  That makes little sense, given that in a randomized controlled trial, the presumption is that differences in groups given different treatments were caused by these treatments.In addition, patients given Vyvanse (lisdexamfetamine) had higher rates of various symptoms that are commonly associated with amphetamines, including insomnia, nausea, constipation or diarrhea, anxiety, feeling jittery, palpitations, and sleep disorder.This suggests that the relatively small apparent benefits of the drug must be weighed against rates of adverse events that are not negligible, especially given the short amounts of time patients were followed. So this study did not show that the benefits of Vyvanse clearly outweigh its harms. Finally, there were many problems with this trial that further cloud its validity, or applicability to patients (generalizability):-  Patients were diagnosed using DSM-4 criteria, rather than the new DSM-5 criteria-  Patients with any other psychiatric illness were excluded, limiting the applicability...
Source: Health Care Renewal - Category: Health Management Tags: clinical trials conflicts of interest deception evidence-based medicine FDA marketing Shire stealth marketing Source Type: blogs