Prescription drugs declared “one of the most significant perils to human health” by British medical journal
by: Earl Garcia
Wednesday, March 15, 2017
butor to the soaring rates of serious, disabling or fatal injuries, according to a 2011 study published in the British Journal of Medicine. Data from the Institute for Safe Medication Practices showed that anticoagulants dabigatran and warfarin were the most frequently identified medications that were reported to the FDA, suggesting that treatments designed to inhibit blood clots top the health risk index among prescription drugs. Nine other drugs were also shown to meet five criteria for clinically-relevant injuries associated with drugs.
The FDA received a total of 179,855 reports of serious, disabling and fatal drug interactions in the U.S. in 2011, a significant 9.4 percent increase (15,386 more cases) from 2010. The federal agency received the highest number of direct calls for the anticoagulants dabigatran and warfarin at 817 and 490, respectively.
Dabigatran was approved in 2010 for the prevention of stroke among patients with atrial fibrillation. Both manufacturer and direct FDA reports showed that the prescription drug was associated with nearly 4,000 serious domestic health conditions in 2011, surpassing many other regularly monitored prescription drugs. Dabigatran was the most commonly reported anticoagulant for hemorrhage, acute renal failure, stroke and liver failure.
Warfarin, on the other hand, is a generic drug that was approved in 1954, and has since become a staple in anticoagulation therapy. The generic prescription drug accounted for 1,106 reports in 2011, including 72 deaths. Warfarin requires regular laboratory assessment to optimize dosing. It also interacts with numerous other treatments.
Other prescription drugs listed were levofloxacin, carboplatin and lisinopril. These prescription drugs each accounted for more than 300 direct reports to the FDA.
Various prescription drugs were also attributed to many direct FDA reports regarding lawsuits filed by injured patients. Metoclopramide tops the list with 11,450 cases filed against its manufacturer. Metoclopramide is used in the treatment of acid reflux and nausea. The drug is tied to irreversible movement disorders.
Oral contraceptives Yaz and Yasmin were hit by 8,354 lawsuits in 2011. The drugs contain synthetic progestin, and are linked to higher odds of blood clots.