A drug causes hundreds of deaths and millions of ADEs

• Published in: Drug Topics 2017-07, Vol.161 (7), p.32
• Main Author: Hamm, Nicholas
• Format: Magazinearticle
• Language: English
• Subjects: Antiarthritic agents; Arthritis; Drug approval; Drug stores; FDA approval; Heart; Patient safety; Pharmaceutical industry; Pharmacists; Researchers; Rheumatoid factor; Studies
• ISSN: 0012-6616; 1937-8157

[...]when warnings have not been issued yet, how can a pharmacist help? A recent investigation by STAT found reports of over hundreds of deaths caused by unlabeled side-effects on the R A medication Actemra (tocilizumab).1 Actemra hit the market in 2010 and many were excited for its apparent benefits over other RA medications. [...]the drug's manufacturer, Roche, saying of a 62-year-old woman's heart attack "The company assessed fatal myocardial infarction as related to (Actemra)." When researchers at the FDA were debating the decision to approve Actemra, they feared that it could be a repeat of Vioxx, another arthritis drug that seemed safe in short-term trials but ended up causing problems with more widespread and longer use. Researchers at the Yale School of Medicine recently found that nearly one in three drugs approved between 2001 and 2010 had major safety issues after approval.2 Part of the problem the STAT investigation found is that many health- care providers have little idea how to handle a patient's complaints that they are having a health problem connected to a drug they are taking. Most of the time the patient is wrong, but what about when the patient is right? A pharmacist should remember that...