Wednesday, May 23, 2007

Who ever reads the package inserts?

The Package Insert from Wyeth for the antidepressant Effexor: In addition to the Black box warning at the beginning, on page 38 includes "homicidal ideation" and "impulse control difficulties". For those of us not in the know, ideation means "The formation of ideas or mental images." Let's see how they present it (added emphasis our own):

Nervous system -

Frequent: amnesia, confusion, depersonalization, hypesthesia, thinking abnormal, trismus, vertigo;

Infrequent: akathisia, apathy, ataxia, circumoral paresthesia, CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, manic reaction, myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech, stupor, suicidal ideation;

Rare: abnormal/changed behavior, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, delusions, dementia, dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barre Syndrome, homicidal ideation, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, libido increased, motion sickness, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes increased, torticollis.
And then there is this bit from the FAQ at the end:

2. How to Try to Prevent Suicidal Thoughts and Actions

To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.

Whenever an antidepressant is started or its dose is changed, pay close attention to your child. After starting an antidepressant, your child should generally see his or her healthcare provider:

· Once a week for the first 4 weeks
· Every 2 weeks for the next 4 weeks
· After taking the antidepressant for 12 weeks
· After 12 weeks, follow your healthcare provider's advice about how often to come back
· More often if problems or questions arise (see Section 3)

You should call your child's healthcare provider between visits if needed.

3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant

Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:

· Thoughts about suicide or dying
· Attempts to commit suicide
· New or worse depression
· New or worse anxiety
· Feeling very agitated or restless
· Panic attacks
· Difficulty sleeping (insomnia)
· New or worse irritability
· Acting aggressive, being angry, or violent
· Acting on dangerous impulses
· An extreme increase in activity and talking
· Other unusual changes in behavior or mood

Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.
I'm sure we all feel much safer now.

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