FDA Investigation of Lantus Cancer Risk Inconclusive

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After a year and a half review, FDA officials indicate that they are unable to confirm a link between the insulin drug Lantus and an increased risk of cancer. However, investigators said they are also unable to rule-out a possible cancer link. 

On January 12, the FDA issued a drug safety communication update regarding its ongoing safety review of Lantus. In the update, the FDA said that the agency’s review of a number of studies and trials has not yet resulted in an ability to conclude that Lantus increases the risk of cancer. However, the review is still ongoing.

Lantus (insulin glargine) is a once-a-day injection that slowly releases insulin into the blood over time. Manufactured by Sanofi-Aventis, it has the second largest share of the diabetic drug treatment market and brought in $3.45 billion in worldwide sales last year. The drug was approved for diabetes treatment in 2000.

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The FDA has been investigating the human insulin analog since July 2009, after four different observational studies suggested an increased risk of cancer with the use of Lantus. However, the FDA said it was limited in its ability to review the studies due to how they were designed and carried out and the data that was available for analysis. A fifth five-year clinical trial comparing Lantus to Neutral Protamine Hagedorn (NPH) did not show an increased risk of cancer.

The studies referenced by the FDA involved analysis of German and Swedish insurance databases, looking at the incidence of cancer among diabetics using Lantus insulin. The study data suggested that low doses of Lantus may increase the risk of cancer 9% and high doses may increase the risk 31%. However, similar databases in Scotland and the U.K. showed no significant cancer risk increases, and the editors of the journal Diabetologia, which published the studies, and the European Association for the Study of Diabetes cautioned that the results were inconclusive.

Patients have been urged by the FDA to not stop their insulin therapy without consulting a physician. Uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects, and patients are advised to contact their doctors if they have concerns about the medicines they are taking.

Tags: Cancer, Diabetes, Insulin, Lantus, Sanofi-Aventis
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5 Comments

Carol
My husband was taking Lantus and developed a tumor in his Pancreas. They removed the tumor and then it showed up in his Liver. He died after 12 months. I am just now hearing these things about Lantus. Makes me wonder if this had something to do with his cancer.I am sure there are a lot of payoffs to keep things like this under wraps. If this was a cause of his cancer it makes me very mad. He will not get to see his grandchildren grow up and we will be without him for the rest of our lives. It”s not fair to have a medicine that is supposed to keep you alive but ends up causing you to lose your life instead!
Sheare
My Mom, who didn’t smoke, drank only a glass of wine at night, and generally cooked and ate far more healthfully than even I do, was diagnosed with a two tumors on her liver, a tumor in each lung and had some bone involvement as well. Leaving aside the fact that her primary care doctor treated her for a bleeding ulcer when she was already at Stage IV and never caught it, I am convinced that it was the Lantus which gave her the cancer, and I am also convinced it is the Lantus that made the cancer so aggressive and quick. And yes, Brenna, someone in the FDA is pocketing funds from big Pharma, and I am including Sanofi. Why not? They’ve already caved to Big Pharma on restricting vitamin use and sales because hey, why do anything naturally if they can give you a subsitute? Listen, I am not anti-medication, I take Wellbutrin to help with fibromyalgia, but listening to the list of potential side effect on the television ads makes me wonder what the hell is going on. And you are right, it’s the lobbyists. I saw a wonderful political cartoon where our elected representatives were drawn with a lobbyist hand inside their backs, making them move and talk. And I’m not even talking about any one political party; as far as I’m concerned, they are all happily serving their corporate masters so said corporate masters can screw the public. I have never understood the mindset of profit at any cost, and hope I never do. But I’m so angry that my mom had to die so quickly and in so much pain that I’m doing research to find out if there’s any possibility of suing the creeps. It won’t bring Mom back, but it will make us feel better that just maybe, it won’t happen to as many people in the future.
Brenna
My dad was taking Lantus as well and was diagnosed with pancreatic cancer and passed away 3 months later. The Swedish study indicated that lantus splits and multiplies the cancer cell. So for someone who is in remission with other forms of cancer like in my dads case (he had a non aggressive form of prostate cancer that was treated 8 years prior with radioactive seeds) what lantus does is it attacks those cancer cells. Anyone in the medical community will tell you that once the cancer cell is present you are always at risk of it returning, in knowing that there are oversees studies that indicate a link between lantus and cancer why would my dads nurse practitioner prescribe this drug. What is more suspicious is that the nurse practioner stopped prescribing lantus to all her patients. And what is even more suspicious is that lantus accounts for 10 % of Sanofi-Adventis’ annual profits, can someone please tell me that the FDA is getting kick backs from lobbyist in the pharmaceutical industry? This would explain alot considering they haven’t started accumulating there own data here in the US only data that is provided by previous studies in other countries. Why? Its definately not for the lack of reported DEATHS associated with this drug in there own back yard. Sadly it would not be the first time lobbyist had an impact on what is tolerated by the government look at all the risks and proven cancer causing additives in cigarettes yet because there is a huge monetary return they slap a warning label on a pack and turn a blind eye. This is outrageous lives are being lost here and we are not being protected!!! If there is an attorney or law firm that wants to take this case please contact me. If I do not here from anyone through the below form submission I will be open to talk with any attorney who posts a comment. Thank you
Norma Jean
My husband died nine months ago as a result of pancreatic cancer. From the start, I suspected his use of Lantus as having a direct connection. I find it laughable that the FDA has trouble suspecting a connection: after all, 50% of the studies they investigated showed a significant relation to Lantus use and cancer. Sometimes you just know something because the evidence is too strong to deny it. My husband experienced lots of side effects that were associated with his Lantus…we just didn’t know about them until it was too late. We assumed he was experiencing “illness”, not “side effects”. The fact that his “symptoms” culminated in the cancerous pancreatic tumor that cost him his life is not likely to lack ties to a drug that is so closely associated with pancreatic function. Like the man said: some evidence is too strong to be called circumstantial, as when one finds a trout in the milk.
jim
I have used lanuts since diagnosis 5 years ago. I had a pancreatic cancer issue ..Is this part of the problem with lantus.

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