تفاوت نرخ های گزارش نادرست در گزارش های ناخوشایند نارسایی درمانی بین داروهای متیل فنیدیت دوبار در روز منتشر شده در کانادا: تجزیه و تحلیل پایگاه های داده گزارش گیری رویدادهای ناخواسته

The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate—their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada.