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Dear Dr. Gottlieb,

As you inch closer to becoming the new head of the Food and Drug Administration, your list of challenges must be swelling. Here is one more item to add: Whether to insist on a stronger warning label for the antidepressant Paxil.


For the past decade, Paxil’s label has not carried any information indicating the drug poses a statistically significant risk of suicidal behavior for anyone over 25. Yet there is scientific evidence that such a risk is real (see table 16 on page 26). A jury in Chicago recently decided that that a label warning could have prevented the death of a 57-year-old man who killed himself while taking a generic version of Paxil.

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  • Agreed. Last month my husband took his own life. A happy, successful, larger than life person, who I know would have never contemplated suicide in his right mind. He had a loving wife, 2 kids, and a support system who he could have turned to if he was truly feeling this way. He wasn’t though…it was an impulsive decision and a mistake…one he can never take back. My husband had been taking Paroxetine (generic paxil) for years and just before he passed, had mentioned to a friend that he wanted to try to get off of it. Instead, he had a panic attack and his doctor put him on a second SSRI just about a month and a half before his death. I understand that there are side effects with any prescription, but how can we notify the general public of the potentially deadly side effects…instead of just saying oh, potentially suicidal thoughts may occur. How about saying, there are known associated suicides with these drugs? I can’t do anything to get my husband back, but I can help to bring awareness so that another family doesn’t have to deal with the heartache that I am going through right now.

  • Agree the damage has been done! Unfortunately in a fast passed “demanding from dawn to night” world, most overwhelmed afflicted prescribed patients would either disregard or not understand small print. Dear Doctor Gottlieb a bold visual symbol (Visual cliff) specific to the issue of induced feeling of suicide with a maximum days of use might save a few good people.

    Also take into consideration that Paxil is not the only drug with such adverse events. There are pain medicines that induce fear of falling, phobia and other type of side effects that could lead to undesired unconscious outcome.
    Only the strong and loved can sometimes seek help and maybe overcome such a adverse events, with additional medical intervention but some succumb in fear leaving their love ones behind.

  • This is only the tip of the iceberg on Paxil.
    Psychiatrists noticed significant problems with Paxil early on. To make up for the lost sales, Glaxo opted for a strategy to market Paxil to primary care physicians who would not be up to date in the kinds of experiences patients were having and treat it like “just another SSRI”.
    Over time, the problems finally caught up with Glaxo and many who took this drug. The tragedy is that many psychiatrists knew for years to only prescribe as a LAST resort, not first.
    This is a cautionary story of why Primary care physicians should stay out of the business of prescribing psych meds and certainly should not be authorizing refills long term.

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