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.
Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more
Subscribe for full-text access to content from 1998 forward and a host of useful features
Activate your current subscription (AMA members and current subscribers)
Purchase Online Access to this article for 24 hours
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
Instructions
Thank you for submitting a comment on this article. It will be reviewed by JAMA editors. You will be notified when your comment has been published. Comments should not exceed 500 words of text and 10 references.
Do not submit personal medical questions or information that could identify a specific patient, questions about a particular case, or general inquiries to an author. Only content that has not been published, posted, or submitted elsewhere should be submitted. By submitting this Comment, you and any coauthors transfer copyright to the journal if your Comment is posted.
* = Required Field
Disclosure of Any Conflicts of Interest* Indicate all relevant conflicts of interest of each author below, including all relevant financial interests, activities, and relationships within the past 3 years including, but not limited to, employment, affiliation, grants or funding, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued. If all authors have none, check "No potential conflicts or relevant financial interests" in the box below. Please also indicate any funding received in support of this work. The information will be posted with your response.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 5
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
and access these and other features:
Register Now
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.
Need assistance?
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.