My fasting glucose level has increased in the last month. I've been taking my meds as directed and my diet has remained the same. I've been injecting Byetta for nearly two years (twice a day). My husband saw that there is a class action suit against the manufacturer because of side effects, damage to the pancreas. I did some reserch on line and found there are all kinds of side effects, damage to the kidneys, liver and G.I. issues.
The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit.
The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for thatendpoint.
I used Byetta for a long time and I am not an expert or medical person. You are best to get the information from your doctor. Before I started using Byetta, I had to take classes from a nurse on how I had to inject Byetta into my stomach. It was prescribed by my Doctor. Byetta has side effects reported by some people but I had no problems with it other than the expense. It does give you a feeling of fullness and it has a nickname (Spit).
shutdown did not affect the timeline for approval. The PDUFA decision date for sofosbuvir is December 8 or 9 depending on where you look. The overall tone of this document is very encouraging for a swift approval. As a genotype 2 hoping for the all oral treatment ASAP this is very good news.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371877.pdf?
I have been put on Lantus, which is working well, but now he (the doctor) has also put me on Byetta. I read all the warnings, and I asked the pharmacy, and they both told me the side effects are nausea, diahrrea, upset stomach and possible life threatening pancreatis.
This bothers me, as my stomach upsets easily, but what I really want to know is how many of you have been on it and what your reactions were? Also, is the chance of being allergic to it very high?
I would really like some help with this. Byetta has been wonderful so far, and I've lost 30 lbs, yay! But now I've developed insomnia - terrible, only 3 hours of sleep a night insomnia, which has never bothered me before. If I skip my second Byetta shot for the day, I can usually get a full night's sleep. So that's certainly a clue that I may not be able to take the full two doses of Byetta a day.
Vertex has begun the application process for approval with the fda. The process should be completed by the end of this year with approval coming shortly after that. The results are promising and I believe the fda is going to put it on the fast track for approval. My doctor told me 6 months ago it will be probably be ready by the end of 2010. Like pcds says though, there is no way to know for sure. It may be sometime in 2011 before it is available.
Hang in there!
I see that this is under juvenile diabetes, which I know even less about. But, Byetta is remarkable for a lot of folks, and there are two newer, similar, products available also.
I actually started on Victoza about 3 months ago. I had to change to Byetta in about 2 weeks (finished Victoza sample and insurance would only pay for Byetta). I developed nausea at the smaller dose of Victoza, and never used the larger dose. The nausea was unchanged with the change of meds.....and I have lost a LOT of weight (29 pounds). But the nausea started within a day or two of starting it. At least for me.
For example, when a patient is proven to be so severely ill that he cannot wait for drug approval, how does the FDA and the manufacturer know for sure if the toxcity of the drug is due to the drug or the severe illness of the patient? It is possible that the drug would be perfectly safe for a Stage 2 patient but not a patient with late Stage 4. In the drug companies eyes, this is not in their best interest when they want to get a drug approved.
Recommended
