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Friday, October 8, 2010

Open Letter to the FDA

Dear FDA,

It is with great concern that I write this. I am baffled by the approval of Victoza (liraglutide) injectable for the treatment of Type 2 Diabetes. In the pre-clinical trials it gave rats and mice cancer. The rate of cancer increased with increased doses and prolonged use. Did you not see this in the paperwork submitted by the drug company or did you choose to ignore it and just put a warning in the packaging?

Are you f*cking kidding me? Were we at a loss of options for Type 2 Diabetes treatment that you were like "F*ck it, let's give them cancer so the last thing they will be worried about is diabetes!" Was that the great and wonderful solution for diabetes: cancer???

I urge medical practitioners and patients not to use this medication. In the past we have found that certain chemicals and medications that give rats and mice cancer also give people cancer. It is only a matter of time before we start seeing predatory lawsuit commercials touting the tag line "Did you or anyone you know get cancer or die from cancer while being treated with Victoza? You may be eligible for monetary compensation! Call XX Predatory & Pals Law Firm today!"

Every time I fill a prescription for Victoza a little piece of my soul withers and dies because I know I am contributing to a greater evil than diabetes and putting a patient's life in danger. These patients are not going to see their doctor for a little throat swelling, soreness, or problems swallowing because they will discount it as something from their acid reflux or some seasonal virus that just won't go away so that by the time they do see their doctor for the tumor that has been churning around in their endocrine system and spitting off little pieces of itself to the rest of the body it will be hard to treat.

I urge you to pull this drug from the market before anyone dies! I hope you realize that by approving this drug each and every life lost because of it IS YOUR FAULT! Fix this mistake before it causes irreparable damage to families across this nation!


Big N Tasty RPH


KB said...

OMG, I feel like a murderer now.

Anonymous said...

You're really wrong about this, and I don't understand your agitation. Victoza causes a certain kind of thyroid cancer in a low percentage of rats at very high doses, but the fact is the very low risk of a very treatable and rarely life-threatening cancer is small compared to the benefits of this drug and compared to the far more serious risks of untreated high blood pressure, high blood sugar, low blood sugar, and obesity.

I found your blog because I am eager to read about Victoza and was searching on the web. I have been taking it for a month and it has changed my life. I hope to take it indefinitely. Why are you over-reading the warnings? Do some homework and relax. You are helping the people to whom you dispense it!

Big 'N Tasty RPH said...

There are so many different first, second, and third line therapies available to treat Type 2 Diabetes that have been out for more than a decade in the general population and are proven safe that it seems wreckless and irresponsible to even introduce the potential for cancer in a patient that is already at the pinnacle of future health problems.

Anonymous said...

I have to agree with the other anonymous post. It's quite obvious that you don't know all the facts. For starters, the name for this drug is liraglutide, not liraglutinide. Additionally, rats and mice are already at an increased risk of this type of cancer. I did a lot of research before I started taking this drug, including talking at length with my endo and DNE. I agree with my doctor and nurse (as well as the FDA) that the benefits of Victoza FAR outweigh the risks.

And the drugs you speak of that have been out for over a decade? Are you referring to glyburide and drugs like it? I had horrible hypoglycemia on that drug, which by itself is extremely dangerous not to mention horrible to experience, and it only works for a short time before it whips the pancreas until it no longer functions at all.

Stop spreading unnecessary fear. It's misinformation like this that keeps people from taking the medicine as prescribed and causes even more damage. If you feel so strongly about diabetes, counsel your patients on the benefits of physical activity and a healthy diet. Put your energy there rather than into spreading fear.

Anonymous said...

PS it's reckless, not wreckless. FYI.

Big 'N Tasty RPH said...

Let me know how many years it takes for your tumor to grow.

Anonymous said...

I don't think this type of back and forth with patients is appropriate, mainly because patients would not be expected to contribute anything more than a testimonial to their short-term personal experience with the drug, and all we as pharmacists could respond would be able to say to that would be 'yep, that's how you feel about it.'

When patients say they researched it, they looked into its use, not comparing the therapy to what else is available, nor comparing it to drugs with similar mechanisms of action. 'I took it for x days, and it has changed my life.' is a pretty standard patient endorsement, meaning zilch. 'Do some homework and relax' is always an ominous statement.

Pharmacists have been in the business of developing a 'gut feel' about drugs for a long haul by the time they graduate, through pre-pharmacy contemplative days, pharmacy school student life, the internship, externship, and whatever else experience is required and then after graduation and working.

With other drugs in the same therapeutic class available, I seriously doubt that the drug company can get away with a mere Black Box warning this time, if cancer is associated with use of the drug. Even though Prilosec overcame the carcinoid tumor association.

Thyroid cancer is nothing to sneeze at, nor is use of any drug which increases chances for cancer. Healthcare information for the prescriber states clearly, "Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise."

I smell a Novo-Nordisk 'rat' in some of the anonymous commenters.

Another pharmacist

Anonymous said...

I personally have only dealt with the Victoza on a couple of occasions and just getting the doctor to send proper dosing directions seems a large hurdle, so I doubt they have read all of the fine print about what the potential side effects may be. The drug reps do their job and the prescriptions end up in the pharmacy-straight and simple. Good for you Big 'n Tasty for trying to educate the public, even though it appears they don't want it.

Big 'N Tasty RPH said...

Victoza has not been studied enough in people to be released to the general public. The first five years of a new drug's release to the general population will have the highest number of deaths and complications that cause it to be withdrawn from market because it was released too soon. This drug should have been studied for at least 10 more years before being released to the public. I have a terrible feeling about this one and I was right about Meridia, which has finally been withdrawn from the market. I would rather be skeptical and have a drug studied for several more years than watch people suffer or die because it was approved too soon.