December 2006 Update: FDA Plans to Extend Antidepressant Suicide Warning
Since 2004, antidepressants have had a black-box warning (the FDA's strongest warning) about an increased risk of suicidal thoughts and behavior in children and adolescents. In December 2006, the Food and Drug Administration federal panel recommended the agency extend the black box warning to alert patients and doctors that antidepressants can also increase the risk of suicidal thoughts and behavior in young adults in their late teens and early 20s. The recommendation to extend the antidepressant suicide warning to young adult patients came after the FDA's review of 372 clinical trials found a small but significant risk of suicidal thoughts and behavior among 18- to 24-year-olds who took antidepressants. The agency said that four of 1,000 patients were at increased risk.
November 2006 Update: Pregnant women are urged to avoid Paxil
According to an opinion published in the December 2006 issue of the Journal of Obstetrics & Gynecology, Pregnant women and those who plan to become pregnant should avoid taking the antidepressant Paxil if possible because of the risk of birth defects. The opinion comes nearly after a year the Food and Drug Administration and manufacturer GlaxoSmithKline reclassified the drug to reflect studies in pregnant women that showed the drug poses a risk to the fetus. Two studies of pregnant women who were taking Paxil during their first trimester have shown that their babies have as much twice the rate of heart defects. The American College of Obstetricians and Gynecologists also said the decision whether to treat pregnant women with SSRIs, a class of antidepressants that includes Prozac, Zoloft and Lexapro as well as Paxil, should be considered on an individual basis. However, reproductive-age women have the highest prevalence of major depressive disorders. The benefit to the mother of treatment with any of the drugs may outweigh the risk to the fetus. (Source: Associated Press)
March 2005 Update: FDA Orders Black Box Warnings On Antidepressants
The FDA ordered 14 antidepressant manufacturers to add "black box" labels warning that antidepressants can increase suicidal behavior in children. Black box labels are the strongest warnings the FDA can issue. The warnings say that about 2 in 100 children taking antidepressants are more likely to think about or try suicide because they're on the pills. The move to place the black box warnings comes five months after the FDA initially ordered them. The FDA has also ordered the antidepressant manufacturers to produce "medication guides" about proven risks and benefits of antidepressants, which will be given to everyone picking up antidepressant prescriptions.
Among the antidepressants to receive the new warnings are Prozac, Zoloft, Celexa, Paxil, and Wellbutrin - the most widely prescribed antidepressants to children.
Only Prozac has been approved to treat childhood depression, but the other drugs can be prescribed legally as an off-label use. Even Prozac causes a 50% higher risk of suicidal behavior in kids, according to an FDA analysis released last fall.
Food & Drug Administration Issues Public Health Advisory. In March 2004, the Food and Drug Administration (FDA) issued a Public Health Advisory asking the manufacturers of ten antidepressant drugs to include warnings on their drugs, cautioning physicians, their patients, and families and caregivers of patients, to closely monitor both adults and children with depression for worsening signs of depression or suicidal thoughts, especially at the beginning of treatment, or when the antidepressant drug doses are increased or decreased.
The antidepressant drugs which the FDA is reviewing for a possible increased risk of suicidal thoughts or behavior and to carry the proposed warnings, include: Prozac (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone); and Remeron (mirtazapine). The only drug that has received approval for use in children with major depressive disorder is fluoxetine (Prozac). Sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox) are drugs approved for the treatment of obsessive-compulsive disorder in pediatric patients.
The FDA also advises that patients taking the antidepressant drugs should be observed for certain other behaviors that are known to be associated with these drugs, such as anxiety, panic attacks, agitation, irritability, hostility, impulsivity, insomnia, severe restlessness, mania, and hypomania. Physicians are also advised to be particularly vigilant in patients who may have bipolar disorder.
The FDA's warning comes in light of several antidepressant studies in children, which suggest an increased risk of suicidal thoughts and actions in the children given antidepressants. Initial reports are unclear as to whether certain behaviors reported in these studies represented actual suicide attempts, or other non suicide-related, self-injurious behavior. The FDA states that It is still not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior.
Last year, British health authorities warned that long-suppressed research suggests certain antidepressant drugs might sometimes increase the risk of suicidal behavior in children and teenagers.
In a February 2004, dozens of anguished parents pleaded in an FDA meeting to add such warnings, recounting children and teenagers who committed suicide after starting the antidepressant drug therapy.
Update - FDA Issues Public Safety Alerts for Several Antidepressants. The FDA and the manufacturers of several popular antidepressant drugs recently notified healthcare professionals of important revisions to their drug warning labels.
Effexor - The FDA and Wyeth Pharmaceuticals alerted doctors that neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Doctors are also warned that, adult and pediatric patients with major depressive disorders, may experience worsening of their depression and/or the emergence of suicidal thoughts and behavior, whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants, including Effexor, be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or when the drug dosage either increases or decreases.
Serzone - The FDA and Bristol Meyers Squibb recently notified doctors of Serzone label revisions which advise doctors to to engage in a thorough risk-benefit analysis, including consideration of the risk of liver (hepatic) failure associated with Serzone treatment, when deciding among treatments available for depression. Furthermore, healthcare providers and consumers are warned about the need for close observation of patients being treated with antidepressants for worsening symptoms of depression, for the emergence of suicidality, and for the emergence of a variety of other symptoms that may indicate a worsening of the patient's condition.
Paxil and Welbutrin - The FDA and GlaxoSmithKline recently notified healthcare professionals of revisions to Paxil and Welbutrin labelling information. The revised label warns healthcare professionals to closely monitor patients with major depressive disorders for worsening signs/symptoms depression and/or the emergence of suicidal thoughts and behavior, whether or not they are taking antidepressant medications. The warnings also recommend that patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or when drug doses are either increased or decreased.
New York Lawsuit Against Drug Maker For Fraud
Lawsuits against pharmaceutical manufacturers for product liability and consumer protection have been traditionally been pursued in lawsuits brought by consumers or consumer groups. Perhaps indicating a trend for the future, the New York Attorney General, Eliot Spitzer, recently brought a lawsuit against drug maker GlaxoSmithKline under consumer protection laws for not disclosing clinical research. The New York lawsuit is seeking disgorgement of profits made by the drug maker for the sale of Paxil to children and adolescents.
The lawsuit accuses pharmaceutical giant GlaxoSmithKline of "repeated and persistent fraud" for concealing problematic issues of safety and efficacy when the company's blockbuster drug, Paxil, is used by children for treating depression. The lawsuit further alleges that Glaxo concealed data showing that in some clinical trials Paxil was less effective in children and adolescents than a placebo, and in some instances the drug could be more likely to cause suicidal feeling.
The lawsuit comes in the wake of reports citing the suppression of negative, unpublished antidepressant studies, and the inefficacy of antidepressant drugs in children and adolescents. In March 2004, the FDA issued a Public Health Advisory urging the manufacturers of antidepressant drugs to place warning on their drugs, cautioning doctors to monitor their patients for worsening signs depression or suicidal thoughts.