Public concern about serious toxicities from marketed drugs approved by the US Food and Drug Administration (FDA) has led to suspicion of both the pharmaceutical industry and the FDA.1 This has caused the FDA to issue severe, black-box warnings about antidepressant use; however, this action may have been taken based on inadequate grounds.2
The central problem is that the current faulty system cannot even detect rare but severe toxicities nor can it detect those that appear late in the use of medication or those that occur during off-label use.3 Furthermore, premarketing clinical trials do not address issues related to possible toxicities due to drug interactions or comorbid illnesses. It is often not recognized that there is no basis from information gained in clinical trials for the original indications that lead to legal off-label use for other indications, nor is the pharmaceutical sponsor responsible for checking on such use. Whether FDA warnings, such as black boxes, that recommend increased monitoring (largely of false-positives)4 or suggest that drug withdrawals actually improve the public health remains unknown.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 6
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.