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VIVUS Inc. Message Board

  • solarman35again solarman35again Jul 14, 2010 1:13 PM Flag

    Ok class, let's go over the adverse effects of QNEXA


    The review, posted on the agency’s Web site, did raise various questions about Qnexa's risks, particularly possible suicidal thoughts, problems with thinking, birth defects, speeding heart rates and acid buildup.

    Because Qnexa might be widely used — including off-label use by people who are not obese but might want to shed a few pounds — the F.D.A. pays extraordinary attention to possible side effects. And some of the drugs in the past have had big safety problems, most notably the fen-phen combination, part of which was withdrawn from the market for damaging heart valves.

    Thomas Wei, an analyst at Jefferies & Company said the agency’s review “leaves us incrementally more cautious.’’ Pointing to the numerous safety questions, he wrote, “We are concerned that the totality of the debated issues will leave the panel uncomfortable with the prospect of such widespread patient exposure in the obesity indication.’’

    There were five safety issues highlighted in the F.D.A. review that the advisory committee will be asked to discuss. Most related to topiramate:

    Birth defects: Some women taking topiramate for epilepsy have given birth to children with cleft lips and other problems. Even though women taking Qnexa in the trial were supposed to use two forms of contraception, 13 children were born.

    “If approved, the person-years of exposure to PHEN/TPM among women of child-bearing age will be enormous,’’ Dr. Eric Colman, deputy director of the agency’s metabolic and endocrine drug division, wrote in a memorandum to committee members.

    Psychiatric problems: Topiramate and other epilepsy drugs have warnings about suicidal thoughts. The review noted that four to seven times as many patients on the high dose of Qnexa as on the placebo dropped out of the trial for side effects related to anxiety, depression or disturbed sleep.

    Cognitive decline: Topiramate is known to cause confusion, memory lapses or problems in concentrating or speaking. In the trial, 7.8 percent of patients on the high dose of Qnexa had such problems, compared with 1.7 percent taking a placebo.

    To be cont'd...

    This topic is deleted.
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    • All the discussion about side effects in the original post were in regards to past history with topiramate.

      The dose of topiramate used in the middle dose of Qnexa is 46 mg, which is quite a bit lower than the 200-800 mg/day prescribed as monotherapy for epilepsy. Unless you've got citations to the contrary, it remains speculative at best and possibly even disproven already that the dosage used in Qnexa has any significant side effect liability whatsoever.

      • 1 Reply to namisgr
      • There's a part in the briefing document or memorandum where some lady with a long history of depression who was on a cocktail of prescription meds ordered some supposed "topamax" off the internet and had an adverse reaction (psycosis I think it was). Gee that has me scared haha. QNEXA IS SAFE AND WILL GET APPROVED!

    • The side effects are serious compared to the cure. If this is the only life-saving drug, I can understand how these effects can be overlooked. But come on people, we are talking about an "obesity" drug that 1) there are others; 2) people don't need this drug by living healthier (diet and exercise); 3)

    • Remember your posts just a couple of weeks ago about how everyone actually gained 17 pounds on Qnexa???????


      You were laughed off the board like the clown that you are.

      Now scurry along board troll.

    • EXCELLENT POST! I got burned badly by Intermune so I've learned to pay more attention to posts on the message boards like yours that discuss side effects that could lead to denial than to the guys who write articles that suggest approval!

      • 2 Replies to ttango2200
      • check my posts on ITMN, I said many times that FDA will reject ITMN because of biased clinical trial results (biased efficacy).
        this time efficacy is not a problem (BTW it's very rare happens) and side effects are not so terrible = positive panel voting and FDA approval.
        I mistake very seldom, so this time I'm positive with 90% probability (ITMN was 90% negative).
        Not a pumper, just player.

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