Comments on: Psychiatric & Heart Risks With Vivus Diet Pill: FDA

By: adele

adele — Fri, 16 Jul 2010 04:46:34 +0000

Excuse me??? PCPs have less experience than psychiatrists?? Anonymous coward must be a psychiatrist, who is unaware of the many medications our patients take outside of the mental health arena. Geez give me a break!

By: keiner

keiner — Wed, 14 Jul 2010 09:04:53 +0000

“Qnexa is a combo treatment - it includes phentermine, which was part of the fen-phen cocktail”

When will they every learn? Deeply frustrating….

By: anonymous coward

anonymous coward — Wed, 14 Jul 2010 00:13:59 +0000

Well, duh!

As a bipolar/ADD patient who has taken topiramate and mixed amphetamine salts (not too different from phentermine) simultaneously, I find it hard to believe Vivus wouldn’t have figured these problems out when Qnexa was first conceived.

Topiramate by itself is a great weight loss product, but not so hot as a bipolar disorder treatment. Regarding cognitive issues, why do you think it’s known as “Dope-a-max”?

Most stimulants, including PSE, methylphenidate, et al are contraindicated for HTN patients and those with various heart problems.

Sheesh, you think somebody would have read some of the literature before going this far. Neither component is something to be taken lightly, no matter how badly one wants to lose weight. IMHO, Qnexa should be prescribed only by psychiatrists as they have more experience with drug combinations like this than PCPs do.

By: Salmon

Salmon — Wed, 14 Jul 2010 00:10:48 +0000

First the categories are not readily recognized and I believe are being phased out.

Second as for Category X this is for situations where the benefits during pregnancy clearly outweigh risks.

I doubt that this would be the case for a diet drug.

Even with pregnancy categories you still need to follow the law.

By: pharmavet

pharmavet — Tue, 13 Jul 2010 23:36:41 +0000

Salmon, why not just approve it with a Pregnancy Category X?

By: Salmon

Salmon — Tue, 13 Jul 2010 16:19:51 +0000

Don’t you think that similar precautions were likely in place during the studies and were more likely to have been actually followed than would occur in clinical practice?

Even so there were still 34 pregnancies out of an unknown number of subjects. I’ve worked on long term trials of psych drugs in schizophrenics and bipolar patients who are hypersexual and less likely to follow such instructions and yet have never seen such a high pregancy rate during clinical trials. (This appears to be several fold higher than anything I’ve ever seen.)

I would like to point out that regardless of our personal opinions on the proper course regarding approval, labeling, and risk mitigation, the FDA is still obligated to follow the law, which I have included below for convenience.

If the Secretary finds…

(2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; …

(4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; …

he shall issue an order refusing to approve the application.

By: pharmavet

pharmavet — Tue, 13 Jul 2010 14:19:06 +0000

Data from the UK show an 11-fold higher incidence of congenital oral cleft malformations in pregnant women who took topiramate compared with the background rate. Given the alarmingly high number of pregnancies in the present studies, I would only approve the drug with a black b warning requiring a black box warning that 1) pregnancy testing must be performed prior to starting the drug, and 2) women of childbearing potential must provide written informed consent attesting to two forms of contraception. This is along the lines for the Accutane warnings.

http://www.neurology.org/cgi/content/abstract/71/4/272