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Spencer Osborne is founder of Satellite Standard Group [SSG], and a partner of Sirius Buzz (http://siriusbuzz.com/). Sirius Buzz covers the satellite radio industry as well as companies that do business in this sector. Sirius Buzz provides information and opinion to readers with an interest in... More
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  • Belviq Adverse Events 14 comments
    Jun 27, 2014 2:42 PM | about stocks: ARNA

    The data from July 1st through September 30th (Q3 of last year) is finally up in a readable fashion from FDAble.com. This would represent the adverse events related to prescription sales of about 48,000 scripts. There were 8 events involving the name Belviq, and 1 event involving the name lorcaserin.

    Below are the events:

    • In case 9519128 Belviq was identified as the primary suspect. The patient was a 73 year old female. The patient complained of abasia, asthenia, balance disorder, a decrease in blood glucose, dry mouth, dysphonia, fatigue, fear, hypophagia, impared driving ability, and polydypsia.
    • In case 9524869 Belviq was identified as the primary suspect. The patient was a 46 year old female. The patient complained that the drug was ineffective and headche.
    • In case 9438727 Belviq was identified as the primary suspect. The patient was female. The patient complained that the drug caused a disturbance in attention, caused a euphoric mood, and made her feel drunk.
    • In case 9456691 Belviq was identified as the primary suspect. The patient was a 72 year old male. The patient complained of abnormal dreams, back pain, cough, depression, dizziness, dry mouth, fatigue, head ache, and insomnia.
    • In case 9460819 Belviq was identified as the primary suspect. The patient was a 49 year old female. The patient complained of aggression, agitation, anger, confused state, depression, disturbance in attention, facial spasm, headache, nausea, suicidal ideation, blurred vision and vomiting.
    • In case 9472852 Belviq was identified as the primary suspect. The patient was a 52 year old male. The patient complained of euphoric mood.
    • In case 9535951 Belviq was identified as the primary suspect. The patient was a 54 year old female. The patient complained of asthenia, confusional state, coordination abnormal, disturbance in attention, fatigue, headache, musculoskelatal stiffness, abnormal thinking, and blurred vision.
    • In case 9549531 Belviq was identified as the primary suspect. The patient was female and required hospitalization. The patient complained of increased blood pressure and paraesthesia.
    • In case 9490915 Belviq was identified as a secondary suspect. The patient was a 39 year old female. The patient complained of abdominal discomfort, chest discomfort, dizziness, dyspnoea, fatigue, feeling abnormal, headache, insomnia, nausea, and pruritus.

    Disclosure: The author is long ARNA.

    Stocks: ARNA
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Comments (14)
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  • umuddafadda
    , contributor
    Comments (19) | Send Message
     
    8 out of 48,000----a 16/thousandth%...is that right? I'll take that.
    27 Jun, 04:21 PM Reply Like
  • Spencer Osborne
    , contributor
    Comments (7543) | Send Message
     
    Author’s reply » Um....

     

    During the same period Qsymia had about 11 out of 120,000 for perspective
    27 Jun, 04:25 PM Reply Like
  • sharinky
    , contributor
    Comments (166) | Send Message
     
    If you are going to attempt to compare Belviq side effects to Qsymia side effects it would be good for you to go on and list them so people can see a comparison of the seriousness of the side effects. Just quoting a number does not show the whole story.
    28 Jun, 09:55 AM Reply Like
  • Spencer Osborne
    , contributor
    Comments (7543) | Send Message
     
    Author’s reply » Sharinky....

     

    I was not comparing side effects. Side effect lists are shown on the label of each.

     

    This subject has been discussed for a while with many people under the false impression that there have been n adverse events for Belviq. Of course, if anyone took the time to sort the raw data they would know that these existed already. The only thing we did not have was the plain text of it.

     

    Both Belviq and Qsymia fare much better than victoza, which had about 300 reports in the same quarter. Very soon we will get the raw data for October, November, and December. I imagine that it will take several weeks for FDAble to get the data to plain English.

     

    As Dax said below, I generated this piece because I had quite a few people say that I was lying when I said that there were about 8 reports in the raw data.

     

    In terms of adverse events, I think that Belviq and Qsymia are and will be in a similar neighborhood. Both can be safely used by the vast majority of patients.
    29 Jun, 09:57 PM Reply Like
  • daxtrdr
    , contributor
    Comments (259) | Send Message
     
    Don't think there is anything particularly interesting about the adverse events thus far. I know why this instablog was generated, however. On another board someone mentioned that Belviq had no, zero events compared to Qsymia which obviously had some. This generated quite a buzz. I was quick to point out to the poster that it may be because FDAble has a lag in reporting events. Sure enough it turns out there is a substantial lag and the fact that Belviq had been on the market for less than a year and that Qysimia had been on the market for longer, explained why Belviq had none and Qsymia had some adverse events. But, the buzz was that Belviq had ZERO events and this was supposed to be wonderful, however, I think anyone who really thinks about it would conclude that this would be impossible.

     

    That being said, I don't think what has been reported is material in any way. The events are relatively minor and reek of the smell of "free lunch" chasers in my opinion.
    28 Jun, 10:22 AM Reply Like
  • P Man
    , contributor
    Comments (1199) | Send Message
     
    Changes in mood, thinking, headache, dry mouth, etc., are not generally considered severe or serious adverse events and are not that uncommon for AE reporting. I would imagine that in all cases, once the drug was stopped, the patients went back to their baseline condition.

     

    Being hospitalized for increased BP is possibly a little more serious, but one out of 48,000 is not any cause for concern.

     

    Not sure why this was posted, really.
    29 Jun, 11:19 PM Reply Like
  • Spencer Osborne
    , contributor
    Comments (7543) | Send Message
     
    Author’s reply » Pman....

     

    I agree that the number of adverse events is minimal. It has been known by some for a while now that there were 8 or 9 events. For a new drug with an unknown mechanism of action, seeing minimal adverse events is good news.

     

    The raw data for q4 of 2013 should be out soon, and we will then have 6 months of data.
    30 Jun, 07:20 AM Reply Like
  • Spencer Osborne
    , contributor
    Comments (7543) | Send Message
     
    Author’s reply » Readers....

     

    For Qsymia there have been 30 reports in what equates to about 275,000 scripts sold. The ratio is 1 in every 9,167.

     

    For belviq, the number are 9 reports out of about 48,000. The ratio is 1 in every 5,334.

     

    It is still quite early with Belviq, but the number of adverse reports for either drug is very low.
    30 Jun, 09:22 AM Reply Like
  • izlowe
    , contributor
    Comments (8) | Send Message
     
    People have more adverse events than this to aspirin. 12 events per 10,000 persons.
    30 Jun, 12:44 PM Reply Like
  • Spencer Osborne
    , contributor
    Comments (7543) | Send Message
     
    Author’s reply » izlowe....

     

    We could go from drug to drug to drug. All drugs have adverse events.

     

    As I have stated, the number of adverse events for Belviq and Qsymia seems to be pretty low, which is good for both companies.
    30 Jun, 12:54 PM Reply Like
  • jakes101
    , contributor
    Comments (757) | Send Message
     
    How do we really know? Many don't complain so we don't know. It does not mean squat...just some more data.

     

    It surely does not mean that the number of adverse events for B and Q were low, we don't know that. How many will mention or complain about a euphoric mood...seriously!

     

    What we only know is that there were few REPORTED, that's about. We can not conclude much more than that.
    3 Jul, 07:50 PM Reply Like
  • Spencer Osborne
    , contributor
    Comments (7543) | Send Message
     
    Author’s reply » Jakes...

     

    Having a low number of reported adverse events is a good thing.
    5 Jul, 11:32 PM Reply Like
  • jakes101
    , contributor
    Comments (757) | Send Message
     
    Spencer,

     

    Agreed, it is a good thing. The method is flawed, hence the lack of excitement.

     

    Unemployment keeps going down, the numbers are improving...this is a good thing. But.... we all know the method is flawed and that many many have given up looking for work or are working under the table, so we don't count them. Minimal excitement.

     

    If everyone was required to fill out a form for Belviq with any side effects they had, I assume the numbers would be quite higher.

     

    Regardless, it is good news, I guess. Yay.
    6 Jul, 05:51 PM Reply Like
  • P Man
    , contributor
    Comments (1199) | Send Message
     
    The method may be flawed, but it's the same method used for all drugs. So by comparison, the Belviq numbers are still quite low.

     

    Same with unemployment. You say the method is flawed (I would disagree with you), but either way, it's the same method that's used over time. So, it should be used from a comparative point of view, to other time frames.
    8 Jul, 01:54 PM Reply Like
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