In January of this year, the FDA approved a new drug for treatment of type 2 diabetes. Victoza (liraglutide) is a once-a-day injection that helps to control blood sugar levels. It is a glucagon-like peptide-1 (GLP-1) receptor agonist that promotes insulin production in the pancreas when digestion occurs.
The FDA says that Victoza should not be used as a first-line therapy for patients whose blood sugar is not controlled through diet and exercise.
There are some safety considerations associated with use of Victoza. Increased incidence of pancreatitis was noticed during clinical trials of the drug. Of 3,900 people tested on Victoza, seven developed pancreatitis. There was only one occurrence of pancreatitis, in patients using a different diabetes drug.
But more troubling is the apparent risk of medullary thyroid cancer that may be associated with use of Victoza. During clinical trials, mice developed this rare form of thyroid cancer when given 8 times the dose of Victoza. This may or may not indicate that thyroid cancer in humans is a risk. More testing is needed to determine that fact.
According to a press release from the FDA, "the agency is requiring the manufacturer of Victoza to conduct a 5-year epidemiological study using a large healthcare claims database to compare the development of thyroid cancer among patients with T2DM who use Victoza to those who are not using this medicine."
A 15 year study will also be initiated to monitor cases of thyroid cancer in people who take Victoza.
Why was this drug approved? The FDA believes that the benefits for people with type 2 diabetes outweighs the side effects of the drug. How do you feel about this? Hit the comment button below and tell us how you feel.
They think? That’s a new one!! Should I laugh now or later?
The benefits are worth the risk for long time type 2 sufferers
I was diagnosed over 20 years ago, I’ll wait 15 years for the results of the further testing, before I use it.
I’d sure like to see a cleaner bill of health for the drug, especially with the new info that maybe it is unwise to try to get blood sugars down to the 90-100 level for Diabetes II people.
I will wait until they can get some real information of the side effects & ets……
All medications should be evaluated on the basis of the effects of use compared to the effects of non use. Medications which give great advantages to a very large percentage of people compared to serious disadvantages to an almost trivial percentage of people should be allowed for use as a patient’s choice. A medication which greatly helps 85% of patients compared to death for 5 out of 100000 should not be taken off the market for everyone. It should be the patient’s choice.
I am type 2. I read the enclosed brochure before I took Victoza and I knew the risks, but the risks of continuing as I was, were worse. Since I have been taking Victoza my Glucose has come down 130 points in the fasting A.M. and almost 160 points before dinner, after eating breakfast and lunch (which is my main meal). This was almost immediate. So I have to say what Byetta, and Symlin didn’t do, Victoza has. I guess all medicines have a risk, but after my good results
I have to give this a chance and maybe after a time I can stop it. Thanks
I believe in being an informed consumer. I’ve had Type II for over 15 years and was put on insulin three years ago. I presently take Lantus and Novalog and maintain pretty good control. I appreciate the information regarding Victoza, but like all new drugs I would want to know all possible side effects (thyroid cancer? Yikes) in order to weigh my options. It should be the patient’s choice.
I couldn’t agree with Carlisle more!
“Apparent risk” of medullary thyroid cancer when mice were given 8x the dose; how many people were in the control group and what other risks did they present during the study; what ARE the benefits of this new drug – none presented – only the scary stuff noted. Does the “apparent” risk outweigh associated heart disease, vascular problems, gout, neuropathy?
I am 65 and was diagnosed with type 2 over 15 years ago. It seems that since people are living to be much older, the risk of cancer and other life threatening illnesses has increased dramatically. If your life expectancy were 55 or 60 then you would most likely be in a position to expire prior to ailments such as these. You might also be willing to risk taking questionable drugs to enjoy life more fully. However in this era, people should try to lower their risks as much as possible. Taking drugs that are risky just doesn’t seem to be worth it. If the majority of us who are afflicted with type 2 would lose weight and exercise more, we would stand a better chance of not suffering the lasting effects of diabetes. But that takes work! I know I should lose 65 – 70 pounds but I haven’t. I don’t have an answer other than we should be able to trust our Doctors. Oh, sure, there is risk in crossing the street, flying in an airplane, eating fast foods, electing a President, and a million other things these days. But I truly don’t think that there should be a medicine on the market that has not proven, beyond a doubt, that it is safe for human consumption or use. We place our trust and our lives in the FDA’s hands, maybe they should wise-up a bit.
Why even put the drug on the market with problems. The FDA is a joke and it’s all about greed and money. How about helping people. Why put something on the market when you know there are going to be problems and endanger peoples’ lives. Would the people at the FDA take this drug if they have diabetes? I doubt it. Just be honest with people.
BP
doesnot appear to be an improvement over the existing available drugs,hence,should be viewed with caution till further resultws are available.
As far as I know, there is not a single medication that does not have some kind of side effect. The decision has to be made as to whether you feel the benefits of the drug are worth the risks.
Because I already have a thyroid problem, I would want to wait and see what they are finding out about possible thyroid side effects. However, if this drug is the only thing that will help me, I might consider, in the future when I’m older, taking it. But that is me, personally. The same might not be true of anyone else, including other members of my family.
This is why patients need to be fully informed about a medication before they start taking it. Unfortunately, I find that doctors rarely say anything, leaving it up to the pharmacist. So, if you aren’t willing to take those risks, it means another trip back to the doctor.
This is unbelievable. My internist wanted me to
try it because it was once a day. Helllooo!
I am not a guinea pig ready for a trial. I will
wait another five years and see how safe it was!
Pidge
Since this is an injectable – why not just use insulin? Why take the risk. I am a Type LADA diabetic and when I was diagnosed I just went straight to insulin – after all – that is what your body uses anyway!
Supposedly, the “fear of needles” is what keeps many docs from prescribing insulin – also, people have to spend some time learning to adjust their dose depending on what they eat, activity levels, and illnesses, but come on…it’s not rocket science.
Every single drug that docs tried to get me to take instead has either been recalled, has a “black box” warning or some other bad outcome. Just do it the natural way and forget it.
Medullary thyroid carcinoma is rare and occurs in about 1 in 500,000 people. There were no victoza related thyroid cancers in the human or primate trials. The complications associated with uncontrolled diabetes is much higher.
Rodents have a higher propensity for this type of thyroid cancer. In fact rodents in the control group that did not receive Victoza, developed thyroid cancer. It is thought that this is because of a relatively high concentration of C-Cells in rodent thyroids which are very low or absent in human thyroids. The post above is also correct, Medullary Thryoid Cancer in humans is extremely rare with only about 600 cases per year.
It is interesting that omeprazole or Prilosec, the first proton pump inhibitor, produced stomach cancer in rodents. It is now over the counter.
I am 56 and was diagnosed with Type II nine years ago. I’ve been taking only Metformin (Glucophage) since Day i, and it has served me very well. My last HgA1c was 6.1. I know that many Type IIs eventually must use insulin. I hope that I don’t, but I also would not take this drug (Victoza) until more is known about it.
Insulin is a bad thing for diabetics. We as a group should be striving for increased insulin sensitivity instead of pumping more insulin into our all ready deaf system. By deaf I mean the cells do not want to handle it. The cells have backed off and disabled the mechanism that allows insulin to do its job. Nothing is said about the other side of the problem which is leptin.
I suggest this new drug be further tested for side effects BEFORE being released to the general public. I would be testing it on diabetic monkeys first not rodents. Some of our apes have a close resemblance body wise to us. Pigs also have a lot of the same organ chemistry as us. A good forensic lab would have a hard time telling the difference between pig flesh and human flesh. It is about 95-99% the same as human flesh. That alone makes it worth using pigs or apes as test subjects. They are closely related animals and would provide better accuracy on results. For that reason I minimize using pork products. They have too much in common and are rift with parasites.
Maybe the patent has run out on the less expensive drugs like metformin and glipizide. (they are dirt cheap and with fewer side effects.) Maybe we should be putting up a bounty to find a cure and put these expensive drugmakers out of business.
They say that with all new Drugs. Would they take it if they had Type 2 Diabetes. Maybe they should tell us if they have Diabetes when they are following trials.
Another killer diabetes drug hits the market. I’m trying to think of an appropriate name for FDA that can be printed on the internet. I was in the hospital a couple years ago with severe dehydration and they watched me for three days to make sure I wasn’t going into lactic acidosis. That was due to metformin and my doctor took me off of it, saying “that’s exactly what that drug will do.” It had been prescribed to me by another doctor. Now that I have moved the new doctor wants me to take Amaryl. It gave me horrible stomach pains. I quit it. The side effects are awful. I am furiously trying to control this by diet and trying hard to exercise as I know how fast your blood sugar can drop by just walking a lot. I will never take a diabetes drug for something that can be controlled by diet and exercise in the majority of people. I hate drug companies and am doing just fine with alternative medicine after years of personal research and communication with responsible physicians. If you are overweight then do the smart thing instead of asking for a pill because you have no discipline. I include myself in that sometimes as I love food, but allow myself one pig-out day a week. You will be astounded at the drop in your blood sugar readings when you lose only 10 pounds and do an exercise that you like. Everyone wants the easy way out, and to get you out of their hair and feel like they have performed their medical duties, the doctors just throw a prescription at you and you leave and drop by a fast food place on your way home then have pizza later that night and drink loads of pop. Again, I repeat, this works for the majority of people. People with serious physiological problems do need help to see what is going wrong in their body. But I don’t want to hear from the whiny little babies who have no self control or discipline to try to work things out themselves free.
I forgot to add this about Byetta:
“Novo Nordisk happy with Victoza launch as group sales climb
02 February 2010
Novo Nordisk has posted a solid set of figures for 2009, and says that the launch of its much-touted diabetes drug Victoza in Europe has been going very well.
Net profit climbed 12% to 10.77 billion kroner (about $2.02 billion), while sales were also up 12% to 51.08 billion kroner, with turnover at Novo’s diabetes division rising 12% to 37.50 billion kroner. The firm’s stable of modern insulin products, including Levemir (insulin detemir) and NovoRapid (insulin aspart) contributed 21.47 billion kroner, an increase of 24%. Human insulins slipped 4% to 11.31 billion kroner, although oral antidiabetic products, notably NovoNorm/Prandin (repaglinide), were were up 11% to 2.65 billion kroner.
Among the major products in Novo’s biopharmaceuticals business, sales of which climbed 11% to 13.58 billion kroner. NovoSeven (recombinant Factor VIIa) was up 11% to 7.07 billion kroner, while the growth hormone Norditropin increased 14% to 4.40 billion kroner.
As for Victoza (liraglutide), Novo’s once-daily human glucagon-like peptide-1 (GLP-1) analogue for type 2 diabetes, chief executive Lars Rebien Sorensen “is very encouraging”. The drug has been launched in Germany, the UK, Denmark, Ireland, Norway, Switzerland, the Netherlands, Greece and Sweden and feedback from healthcare professionals and patients has been positive, the company says.
In Germany, the GLP-1 class constitutes more than 3% of the total diabetes care market, Novo says, and Victoza has captured more than 52% of that from Amylin/Eli Lilly’s blockbuster Byetta (exenatide). Liraglutide has recently been approved in the USA and Japan.
Byetta Rejected By FDA Over New Formula
The U.S. Food and Drug Administration has declined, at least until more information is provided, to approve a new formula for the drug Byetta, which is taken to regulate diabetes. The FDA said it needs more information about the manufacturing process used by the drug’s makers, Eli Lilly and Amylin Pharmaceuticals. The government agency also wants to know how the companies will mitigate any health risk to consumers before approving the drug.
http://www.newsomelaw.com/blog/2010/03/25/byetta-rejected-fda-over-new-formula
Let’s not overlook this damaging news today from Saudi re Avandia
“The side effects that have been reported include bone fractures, congestive heart failure, risk of heart attacks, eye damage, and acute hepatitis. Saudi Arabia, specifically the Saudi Food and Drug Authority (SFDA), has the opinion that the side effects from Avandia outweigh the benefits received from taking the drug, and that there are other safer alternatives on the market for type-2 diabetes patients. While the drug will still be available on pharmacy shelves until sold, there will be no new shipments allowed for at least the next six months.”
Yes, I agree, taking any newly released drugs can be a huge risk… if I have to anything, I will always wait for it to be out for some time first and then I will then do a search for forums exactly like this and and see how people are responding to it.