FDA Issues Public Health Advisory on Antidepressants

The US Food and Drug Administration recommends that all patients (children and adults) beginning treatment with antidepressant drugs especially Selective […]

The US Food and Drug Administration recommends that all patients (children and adults) beginning treatment with antidepressant drugs especially Selective Serotonin Uptake Inhibitors (SSRI’s) or when changing their dosage, be closely monitored for “worsening depression and suicidality,” according to a March 22 Public Health Advisory.  Manufacturers of the drugs Prozac (fluoxetine), Zoloft (sertraline), Paxil (paroxetine), Luvox (fluvoxamine), Celexa (citalopram), Lexapro (escitalopram), Wellbutrin (bupropion), Effexor (velafaxine), Serzone (nefazodone), and Remeron (mirtazapine) have been asked to include that warning in their labeling.

The Advisory lists other potential side effects of these antidepressants, including “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania.”  The Agency urges particular vigilance in “patients who may have bipolar disorder.”

Untreated depression is widely recognized as a leading cause of suicide, and many patients do benefit from medication.  If one particular medication proves ineffective, doctors typically prescribe another, often successfully.  FDA cautions that it is not yet clear whether antidepressants contribute to suicidal thoughts, “worsening symptoms could be due to the underlying disease or might be a result of drug therapy.”  Patients disappointed with medication results should seek medical attention, as there are other options.

These options include an older class of antidepressants known as tricyclics.  While doctors may see Selective Serotonin Uptake Inhibitors (SSRI’s) as the latest, greatest treatment, the UK’s Cochrane Review concluded:  “There are no clinically significant differences in effectiveness between [SSRI’s] and tricyclic antidepressants.  Treatment decisions need to be based on considerations of relative patient acceptability, toxicty and cost.”

FDA advises particular caution, “_ at the beginning of treatment, or when the doses are changed with either an increase or decrease _,” recommending, “if a decision is made to discontinue treatment, certain of these medications should be tapered rather than stopped abruptly.”

“WARNING: Withdrawal can often be more dangerous than continuing on a medication,” writes Ann Blake Tracy, PhD.  Tracy, the Director of the International Coalition for Drug Awareness (ICFDA), has authored a book titled, Prozac: Panacea or Pandora.  Tracy strongly urges patients not to discontinue antidepressants “cold turkey.”

Tracy’s book addresses new generation SSRI’s, which work by increasing levels of serotonin.  An ICFDA Position Paper Tracy authored raises another potential risk.  “There is an alarming connection between alcoholism and the various prescription drugs that increase serotonin.”  “[M]any other patients who had no previous history of alcoholism have continued to report an ‘overwhelming compulsion’ to drink while using these drugs.”

Tracy goes on to hypothesize on the cause of the connection between SSRI’s and excessive drinking.

“Could it be that because these drugs have such a strong adverse effect upon the pancreas [Manufacturer’s warnings include such side effects as hypoglycemia, diabetes and pancreatitis] they are producing a potent disruption in the body’s blood sugar balance?  This would in turn cause a ‘craving’ for alcohol as the body reaches out for a ‘quick fix’ to raise the blood sugar level thus triggering a vicious self-perpetuating cycle as the alcohol pushes the blood sugar level even lower after the brief high it produces.  This means that those suffering a tendency toward alcoholism or any other blood sugar disorder would suffer the most disastrous repercussions of Prozac, etc., (including psychosis, suicidal ideation and violence) much faster than most,” writes Tracy.

Research conducted at Sweden’s Goteborg University concluded,  “Half the women with ADA (alcohol dependence/abuse) also had a depressive disorder, and 25 percent of the women with depressive disorders also had ADA.”

Major depression is a serious illness treated with powerful drugs.  Given that both the disease and its treatment affect one’s mood and thought process, patients need to be armed with information about side effects and options, including the older class of tricyclic antidepressants.

Suzanne Vogel Scibilia, M.D., a psychiatrist and member of NAMI’s Board of Directors, testified at an FDA hearing on antidepressants and children on February 2, 2004. She stated that “With so many children and adolescents being prescribed psychotropic medications, we need research and science to help guide the safe and effective use of these medications.”  Dr. Vogel also urged that we “address the critical need to ensure that all children and adolescents with mental illnesses have access to evidence-based assessments and interventions – with quality clinical care as an integral part of all aspects of the service delivery system.”

Medications to treat depression are effective, but the side effects need to be monitored. To learn more, log onto the following websites: Food and Drug Administration at http://www.fda.gov; International Coalition for Drug Awareness at http://www.drugawareness.org; http://www.nami.org or search keyword “depression” for clinical research abstracts.

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