Healthy Skepticism Library item: 274
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Publication type: news
Starnes R.
Popular antidepressants can increase suicide risk, U.S. warns: Doctors, caregivers told to be vigilant when medication starts or dose changes
Ottawa Citizen 2004 Mar 23
Full text:
American doctors, families and caregivers have been warned to keep a close watch for suicidal tendencies among patients on some popular antidepressants.
The U.S. Food and Drug Administration has also called on drugmakers to change labels on 10 drugs. They want stronger warnings of the possible suicide risk associated with the pills.
Industry analysts suggest the global market for the 10 drugs may be worth $13.7 billion this year. They are Zoloft, Pfizer Inc’s $3.1 billion-a-year seller, Prozac, Paxil, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are known to affect the brain chemical serotonin.
Health Canada suggested yesterday drug companies selling antidepressants in this country already have to provide warning notices in all prescribing information. The department said it was in the middle of a review of antidepressants. Currently, there is no plan to demand sterner warnings on bottles. Twice last year, Canadian doctors were warned that a widely used antidepressant had been linked to a possible increased risk of suicidal thinking in children.
The manufacturer of Effexor wrote letters to about 40,000 doctors warning them to watch for “signs of suicidal ideation in children and adolescent patients prescribed the drug.”
Then the manufacturer of Paxil told doctors the drug should not be given to children under 18 “due to concerns of a possible increased risk of suicidal thinking, suicide attempts or self-harm.”
Neither drug has been approved for use in anyone under 18. But Paxil, Effexor and other drugs designed for adults are being prescribed “off label” to children and teenagers.
The FDA action is aimed at adult and pediatric use of pills to alleviate depression. But Girish Tyagi, a doctor and drug analyst with Thomas Weisel Partners in the U.S., says doctors are unlikely to stop prescribing the medicines.
“The suicide risk has been known for 10, 20 years,” he said.
The FDA is stressing it isn’t clear yet that the drugs actually do lead to suicide. But yesterday, it followed its advisers’ recommendation and issued a public health advisory putting doctors, patients, families and other caregivers on notice to be particularly vigilant for signs of worsening depression or suicidal thoughts at the beginning of antidepressant therapy or whenever the dose is changed.
Concern over drugs to treat depression has been gathering strength in the past 12 months. British health authorities sounded the alarm last year, saying long-suppressed research suggests certain antidepressants might sometimes increase the risk of suicidal behaviour in children and teenagers.
Because only Prozac has been proven to alleviate pediatric depression, Britain declared others — drugs called SSRIs and their close relatives — unsuitable for depressed youth.
The FDA issued a caution on pediatric use last year, but yesterday’s action — especially the addition of the warning on labels — goes significantly further.
It’s a difficult issue to sort out because depression itself can lead to suicide, and studies clearly show that antidepressants have helped many people recover from depression.
Despite that, dozens of anguished parents pleaded with the FDA in a meeting last month to add such warnings, citing preteens and teenagers who hanged themselves or slashed their wrists shortly after starting the antidepressants.
Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. But 109 patients experienced one or more possibly suicide-related behaviours or attempts, the FDA says.
The studies varied dramatically in what was considered suicidal behaviour, making a clear link difficult, FDA scientists say. For example, among 19 patients classified as cutting themselves, almost all were superficial, with little bleeding.
Worse, the youths most likely to commit suicide weren’t allowed into those studies, so existing data likely won’t settle the issue, the FDA’s scientific advisers have warned.
