Editorials Respond to FDA Advisory Committee Recommendation on Antidepressants

Several recent editorials responded to a decision on Tuesday by an FDA advisory committee to recommend that all antidepressants include a black box warning -- the strongest warning issued by the agency -- to inform consumers that the medications can cause suicidal thoughts and behavior in patients ages 18 and younger (Kaiser Daily Health Policy Report, 9/15). Summaries of the editorials appear below.

• Akron Beacon Journal: The "controversy" over the use of antidepressants in children "further points to a fundamental problem in the process by which the federal government tests and approves drugs for use by children," a Beacon Journal editorial states. "The larger issue is the need for drugs that have been tested and approved specifically for children," the editorial states, adding that because medications often are tested only in adults, physicians "have little option but to prescribe the drugs, with modifications for children," off-label. The editorial concludes, "In the absence of drugs labeled for pediatric use, the FDA must ensure that drug manufacturers provide explicit information on the risks of any drugs that might be used for children" (Akron Beacon Journal, 9/15).
  
  
• Cincinnati Enquirer: Recent concerns about the effect of antidepressants in children represent "medical science unfolding at its messiest" and require "caution but not an immediate rejection or embrace of antidepressants for children," according to the Enquirer. The editorial concludes, "Antidepressants in use today have been developed for and tested on adults. We need research aimed at children and a clean, objective space -- free of drug company marketing and FDA stalling -- to view it in" (Cincinnati Enquirer, 9/16).
  
  
• Denver Post: The recommendation to include a black box warning on all antidepressants is a "prudent move," but the "key issue is the fear that the warnings might needlessly deter prescribing the drugs for people who need them," a Post editorial states. The editorial continues, "The 'black box' warnings are a good idea, but the most effective safeguard probably is for families and physicians to be vigilant about watching for signs of undesirable side effects from antidepressants in young patients," adding, "It would be a tragedy for youngsters to suffer from depression because fear prevents them from getting they medication they need to improve their lives" (Denver Post, 9/16).
  
  
• Long Island Newsday: "The recent controversy over antidepressants, children and suicide is really about trust," a Newsday editorial states. "Sick people have to trust their doctor's judgment about the drugs they take. Doctors have to trust the information they get from drug companies. The public has to trust government regulators to ensure that drugs on the market are safe and effective," the editorial states, adding, "Unfortunately, for depressed children, that critical trust has been squandered. Washington has to find a way to get it back." The editorial recommends a public registry of clinical trial results, concluding, "When it comes to powerful drugs of any kind, and the complex pluses and minuses inherent in their use, doctors and the public need all the information they can get" (Long Island Newsday, 9/16).
  
  
• Los Angeles Times: The FDA advisory committee "made a tough but correct call Tuesday," a Times editorial states, adding that researchers "have yet to make the case that, for all children, the drugs' risks outweigh their benefits." According to the editorial, at a "minimum, the FDA should promptly require drug companies to put prominent warning labels on the medications, strong enough to make doctors and parents think twice." The editorial adds that actions by FDA to conceal related clinical trial results "should spur demand for more public scrutiny." In addition, the editorial states that "prominent health leaders, such as the surgeon general, should draw attention to the fact that primary care doctors have increasingly prescribed antidepressants for children without explaining their risks and limitations to parents," who should work to educate themselves about the risks and benefits of the medications (Los Angeles Times, 9/16).
  
  
• Miami Herald: FDA "should follow a panel's recommendation to warn doctors and patients in strong terms that some children and teens who take antidepressants might try to commit suicide," a Herald editorial states, adding that the agency advisory committee "made the right call." Several organizations have called for public disclosure of all clinical trial results, and FDA "should follow suit," the editorial adds. "Most over-the-counter drugs include long lists of potential side effects. The FDA should require no less from drug companies that produce antidepressants. Anything less than full disclosure is a threat to public health," the editorial concludes (Miami Herald, 9/16).
  
  
• New York Times: The recommendation from the FDA advisory committee is "quite right" and "every bit as depressing as the original warnings raised months ago," a Times editorial states. "There is remarkably little evidence that most of the pills are effective in treating depression in such young patients and increasing evidence that they can lead to suicidal thoughts and behavior," the editorial continues. "What patients, parents and doctors most need is not just a warning but the clearest possible guidance as to which of these drugs are safer and more effective than the others," the editorial concludes (New York Times, 9/16).
  
  
• San Francisco Chronicle: The recommendation from the FDA advisory committee was "long overdue," and the agency should have "aggressively investigated antidepressants earlier," according to a Chronicle editorial. "Anxious parents and prescribing doctors would have benefited from a thorough study," the editorial states, adding, "That work has finally been done, but its tardy arrival has undercut the agency's reputation" (San Francisco Chronicle, 9/15).
  
  
• USA Today: The recent "controversy" over antidepressants indicates that "withholding information can be more damaging to drug companies than making full disclosure that helps parents and physicians make wise choices about treatment," a USA Today editorial states. The editorial recommends a public registry of clinical trial results to help address the issue. "The foot-dragging over releasing the results on antidepressants shows that patients can't depend on voluntary compliance by the industry," the editorial states, adding, "Mandatory disclosure of relevant information on all prescription drugs is the soundest course -- especially when life or death is at stake" (USA Today, 9/15).