This topic contains 24 replies, has 9 voices, and was last updated by WV_narcoleptic 3 weeks, 5 days ago. This post has been viewed 3625 times
- August 4, 2017 at 12:26 pm #2584
I’m hoping people will share their experiences with Xyrem (Sodium Oxybate) openly. It’s a controversial medication manufactured by a controversial company.
It seems to be considered a wonder drug by some and a nightmarish experience to others. I don’t have a particular stance for or against the medication but do believe pharmaceutical companies should accurately report side effects. Unfortunately post marketing research appears to be rubbish on Xyrem. These are some excerpts from a study on Xyrem related fatalities and Jazz failing to report adverse effects:
The results of a post-marketing safety study indicated 30 fatalities had occurred in patients prescribed sodium oxybate from 2002 through early 2008, although most were determined to be unrelated to the medication.
In a report filed with the U.S. Securities and Exchange Commission, Jazz Pharmaceuticals recently revealed the central pharmacy failed to report the deaths of 74 additional patients who received sodium oxybate between 2003 and 2010 and were not reported to the FDA.
It is also troubling that the actual number of deaths is unknown because a well-recognized flaw of passive reporting systems is their reliance on physicians to voluntarily report serious AEs, including fatalities. Studies indicate underreporting of AEs by physicians ranges from 86-96%, including serious and fatal events.
Based on the failure noted above, 3rd party surveillance by a non-stakeholder should become the standard and be the rule for mandated risk management programs. Jazz Pharmaceuticals should conduct a prospective study using active surveillance rather than passive physician reporting.
The full text can be found below.August 4, 2017 at 2:52 pm #2591
I have no idea if my Xyrem prescriber gave the full list of my side effects to Jazz Pharmaceutical. This list is LONG i.e., sweats, anxiety, tremor, high blood pressure (160/100), high resting heart rate (108), absolutely no appetite for food, and a strange feeling right where my liver is. I called the Xyrem REMS program and dropped out of taking Xyrem.
Prescribers themselves don’t want Xyrem to fail with their patients especially if it’s a kind of “last resort” medication so I’m guessing that when their patients drop out of the REMS program they tend to underreport or maybe even not report at all the side effects patients had on Xyrem.
I can only speak for myself and Xyrem proved to be a powerful and DANGEROUS medication. While I was on it I called the REMS program repeatedly about the side effects. What I don’t know is whether they report side effects to the FDA or the prescriber does such reporting. I’m sure this drug has killed people. I could have had a stroke or heart attack myself while on it.
Sleepyhead.August 4, 2017 at 4:24 pm #2592
@eleuthero it’s likely no one reported it.
You can report side effects directly here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.homeAugust 4, 2017 at 4:31 pm #2593
I reported my side effects to SDS. The woman on the phone was very dismissive, said it was probably something else I was taking. I doubt she did anything as far as reporting those issues up the chain of command.
My current jam: Anathema - SpringfieldAugust 4, 2017 at 7:55 pm #2594
What I like about this forum IS the honesty, no one here judges and I think that is important as we try to find the best ways to deal with this illness.
That being said I would remind everyone that if you are considering this medication I recommend speaking with others who have used the drug. Of course Jazz is going to try and shield themselves and I am sure under reporting is a problem. Both Jazz and SDS exist to sell their product just like any other pharmaceutical company.
I think we all need to keep in mind that nearly all of the medications prescribed for this condition can be and are deadly if not properly prescribed with careful attention to detail and thorough investigation into interactions and contraindications to other medications which we take.
Look, taking any medication is a crapshoot, especially if we have not taken the medication before or if we are new to pharmaceuticals in general. Don’t forget folks penicillin still kills hundreds of patients every year.
Just my 2 centsAugust 4, 2017 at 8:22 pm #2595
I agree with your assessment Natdoc.
On the other hand, it would be helpful if there was a third party phone number, e-mail address or website where reactions to ANYTHING could be reported and hopefully acknowledged. Reporting to Jazz or your Doctor or the FDA are not uninterested third parties because they benefit from suppressing bad reactions. FOLLOW THE MONEY.
Who will speak for us?August 4, 2017 at 11:03 pm #2596
You are absolutely right, there should be a non biased citizen watch group to monitor adverse events. All pharmaceutical companies who peddle their products in this country should have to be registered and should also have to subscribe to this board. Likewise all hospitals in order to maintain JCAH accreditation must subscribe. Failure to report events would result in severe penalties such as fines and suspension of accreditations.
I am sure this would be a massive undertaking and most likely result in arguments on capital hill. I don’t think the pharmaceutical companies or hospitals would agree voluntarily.
Ahh well back to realityAugust 5, 2017 at 9:25 am #2605
The thing that worries me about Xyrem is the underreporting and dismissive attitude of the nursing hotline. Time and time again I’ve seen posts about pwn complaining about excessive sweating, tachycardia, anxiety, and so on. When people call the hotline, they seem to be told, it’s impossible and has to be something else. I think these events are very likely going unreported.
Most of the literature suggests Xyrem is very well tolerated by most patients but this doesn’t seem to reflect reality. I believe the official figure for excessive sweating is .4%, which is very likely total nonsense. Tachycardia also seems quite prevalently complained about. If Jazz is failing to report 2 of every 3 deaths, the chances of accurate reporting of other side effects is extraordinarily low.
I’m not wanting the drug to be taken off the market but I believe openly discussing side effects and risks with accurate information is extremely important for patient safety. I’m also concerned that in animal studies chronic use seems to cause permanent brain damage, particularly in the areas of the brain responsible for memory.
The side effects profile of Xyrem after it’s worn off is remarkably similar to that of a potent cns stimulant. Based on my experience, it acted like a pseudostimulant. I could barely sleep four hours on it but was wide awake, yet still felt deeply sleep deprived. I felt crazy on it and like something was killing me. I had two MRIs performed the first showed no abnormalities. The second showed white matter lesions consistent with MS. It could entirely be coincidental, but more research needs to be performed on the safety of the medication by independent researchers. Jazz has clearly failed to live up to their legal obligations.
With virtually all medication, if you experience side effects, you’re told to discontinue. However with Xyrem, you’re told to tough it out, which is what I did and it ended disastrously for me. The program is setup in such a way that increases the risk of the medication.
Again, I’m not for or against it but I’d like better independent monitoring. I’m thrilled it works well for some pwn. But the way the medication is reported and frequently prescribed needs to be seriously overhauled.August 5, 2017 at 1:21 pm #2612
@natdoc totally agree regarding honest and respectful discussion on here. I respect your opinions a great deal. I was hesitant to start this thread because I was concerned it might cause divisiveness. I’m sure you’ve seen Xyrem change lives and that’s awesome. Ultimately I think healthcare professionals want the same thing patients do, successful outcomes. When healthcare professionals aren’t receiving accurate accounts of adverse effects, it’s a disservice to both patient and professional.
Unfortunately when huge sums of money are involved, companies don’t always act ethically. Jazz has a poor track record but sadly so do most pharmaceutical companies. Xyrem sounds great on paper. It seems much safer and better to improve sleep as a treatment than to dose people with powerful stimulants, which is how it’s marketed. I’m just skeptical that’s how it actually works based on the side effects profile and my personal experience.
I posted a separate thread for Xyrem success stories to balance it out and to encourage people to post those as well.
Anyway I hope no one takes anything on here personally or in any way hostile. I respect differing opinions.August 5, 2017 at 9:17 pm #2633
I think everyone here is aware of how dangerous pharmaceuticals are, that is why they are never my first option for treating sleep disorders. Lets face it folks there are only a couple sleep disorders that are not environmental in nature. We were not born with sleep disorders we have grown into them, and although I certainly can’t prove it, my belief is that narcolepsy may have an environmental component.
Sunlight, Diet, Lifestyle and exercise. I use certain teas and herbs to consolidate sleep and others to boost the immune system. If I use pharmaceuticals my first option is low dose naltrexone, I seem to have good response with this regimen. I do have many folks currently using xyrem as well as stimulants also. ANY adverse event in my opinion is a reportable event, we are never going to truly know the success rates of medications without true and honest exchange. Unfortunately we don’t have that so I urge anyone who is taking medication for this illness if something out of the ordinary is occurring do your homework talk to someone even here on these forums if need be, but DO NOT continue taking a medication you are uncomfortable with
Sorry for the long rantAugust 6, 2017 at 4:06 pm #2640
If ranting on here is something you have to apologize for, I’ll be doing hail Marys until the end of time.
I think the evidence supports your environmental theory, natdoc. People born with narcolepsy have a mutation in an orexin receptor but that’s unbelievably rare. The streptococcus infection connection is pretty strong for n+c. Vitamin D deficiency is linked to other autoimmune diseases so that could play a role too.
Then there’s the weird fatty acid/choline metabolic genetic variant association. I’m just speculating but because other beta oxidation defects can cause increased oxidative stress and neurological damage, some cases could have a strong link to lifestyle. Some case studies have suggested sodium oxybate intolerance is the result of a genetic metabolic disorder. It’s interesting stuff!December 16, 2017 at 11:37 am #4186
Hi Jason. I came across your page as I was specifically google searching metabolic issues and Xyrem. I have 25+ auto-immune related issues including a metabolic issue. My doctor’s office is trying to invalidate my narcolepsy diagnosis for the sole reason of my struggles with Xyrem and stimulants. They have gone as far as to say my overnight and MSLT must be “false positives” as that is the only accepted explanation to them as to why the medication is not working. The lack of cooperation from this office has also caused my disability attorney to drop my case. This whole situation is absurd! So I’m trying to pull together my own research and evidence. My genesight testing has confirmed that my genetic makeup does not respond to stimulants. I am trying to find something to support my belief that my metabolic issues are also effecting Xyrem.
Your last thread post on 8-6-17, you mentioned, “Some case studies have suggested sodium oxybate intolerance is the result of a genetic metabolic disorder.” If you still check this forum or get an email alert, could you please send me links for those studies? I’ve not been able to find any so this would be much appreciated!!December 16, 2017 at 11:58 am #4188
I should clarify, I have only been able to find ONE genetic metabolic diagnosis (called succinic semialdehyde dehydrogenase deficiency) that says should not take Xyrem. I do not have that condition but I do have other metabolic disorders. I can’t find any articles about other metabolic disorders and Xyrem effectiveness tho. Are you aware of others?December 16, 2017 at 12:16 pm #4191
That’s ridiculous that they are like, “the treatment doesn’t work so you must be a fake pwn”. Stimmies and Xyrem give so many people issues. It could be a metabolic issue with me, as I know I have Gilbert’s so other liver enzyme issues might be possible. Alternatively, I also think some ppl’s neurochemistry doesn’t respond well to being gamed with stimulants or Xyrem.
My current jam: Anathema - SpringfieldDecember 16, 2017 at 12:35 pm #4193
Oh believe me, if I shared all the details, the entire N community would be angry as well! The GeneSight testing supports my stimulant issue as that test includes ADHD medication. Unfortunately, there isn’t a test for Xyrem. I wish I had the PhD brain to be able to comprehend the scientific parts of being able to take my genetic info and somehow make a connection to Xyrem, basically do the job that my doctors are refusing to figure out for me. I requested and picked up my records last week. Even their notes contradict themselves. I’ll be filing a grievance as soon as I can get it all together. I have also made my new attorney aware of all of this. Now if I could just find a genius who can put this genetic and Xyrem connection together for me, that would be awesome!
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