October 26

FDA Asks Antidepressant drug companies to add Cautions on labels

FDA Asks Antidepressant drug companies to add Cautions on labels

Mon, 22 Mar 2004

The FDA has “requested” drug companies to put prominent warnings on the labels of 10 antidepressant drugs, “to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.” The warnings apply to children and adults.

The FDA did not clearly spell out that it is the drugs that most likely trigger suicidal and aggressive behavior. In clinical trials these high risk behaviors occurred in children taking the drugs, not those taking placebo.

By failing to identify the reasonable evidence linking the drugs to the high risk behavior, the FDA is shielding manufacturers from legal liability. Nevertheless, prescribing physicians will be on notice that these drugs are not benign–as they had been led to believe. They will have a clue that antidepressants should not be prescribed like a panacea.

The FDA has given in to public pressure after compelling testimonies of grieving families at a public advisory committee hearing (February 2). In that sense this is a victory for those who have for years advocated for drug warnings. FDA’s advisory committee was persuaded by the credible testimonies. The testimonies corroborated the analyses of independent experts that found reasonable evidence linking antidepressants to increased risks of harm to self and others.

The FDA continued to deny a problem existed until the concealed, unpublished evidence uncovered in court proceedings reached the public arena. In fact, FDA’s chief counsel filed an Amicus Curiae brief stating that Pfizer, manufacturer of Zoloft (one of the antidepressants that will now have to carry a warning) the FDA would prohibit the company from putting a warning label about the potential suicide risk because that would be “misbranding.”

The FDA has failed to provide leadership. FDA officials are passing the buck and playing for time by turning the clinical trial data that was in its possession for over a decade to Columbia University for “re-analysis.” Why did the FDA fail to do its own analysis over the years and report the findings?

Conflict of interest is the major reason for the concealment of evidence not favorable to drug manufacturers. Concealment of the evidence has led to unwarranted and risky prescribing of antidepressant drugs and has resulted in preventable suicides. The public good will be served only when all clinical trial data is publicly available for independent analysis and validation. Columbia is one of the major stakeholders in psychiatric drug research and its faculty has been in the forefront of publishing unsupportable “positive” reports that misinformed doctors by stating that antidepressants were “safe and effective” for children. What credibility will an analysis by stakeholders in the industry have?

Why does the FDA not accept the finding of its own independent medical expert who has analyzed the data? Dr. Andrew Mosholder analyzed the data and corroborated the findings of Dr. David Healy and the analysis of the British Medicine authority.

Contact: Vera Hassner Sharav
Tel: 212-595-8974
veracare ahrp org

FDA Talk Paper
March 22, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Issues Public Health Advisory on Cautions for Use of Antidepressants in Adults and Children The Food and Drug Administration today issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

FDA has been closely reviewing the results of antidepressant studies in children, since June 2003, after an initial report on studies with paroxetine (Paxil), and subsequent reports on studies of other drugs, appeared to suggest an increased risk of suicidal thoughts and actions in the children given antidepressants. There were no suicides in any of the trials. On close examination of the initial reports, it was unclear whether certain behaviors reported in these studies represented actual suicide attempts, or other self-injurious behavior that was not suicide-related.

FDA has initiated a full review of these reported behaviors by experts in such evaluation. However, it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior. The agency is advising clinicians, patients, families and caregivers of adults and children that they should closely monitor all patients being placed on therapy with these drugs for worsening depression and suicidal thinking, which can occur during the early period of treatment. The agency is also advising that these patients be observed for certain behaviors that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania, and that physicians be particularly vigilant in patients who may have bipolar disorder.

FDA is asking manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. It should be noted that the only drug that has received approval for use in children with major depressive disorder is fluoxetine (Prozac). Several of these drugs are approved for the treatment of obsessive-compulsive disorder in pediatric patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the United States.

These interim actions follow recommendations made by FDA’s Psychopharmacologic Drugs and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committees, which met on February 2, 2004. The advisory committee members advised FDA that the labeling should draw more attention to the need to monitor patients being treated with certain antidepressants.

FDA has previously noted (in Public Health Advisory and a Talk Paper T03-70 published Oct. 27, 2003) the possible finding of increased suicidal thinking or behavior, but emphasized that it was not clear that the drugs caused such events and additional analyses were being done to allow FDA to seek more definitive answers.

The Public Health Advisory containing the new label warnings and cautions is available online at http://www.fda.gov/cder/drug/antidepressants/default.htm.

Later this summer, FDA plans to update the Advisory Committees on the results of the expert analyses and its own analyses of the pediatric suicidality data.

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