FDA Announces Investigation Into Revlimid, Thalidomide, And Secondary Cancers
The U.S. Food and Drug Administration (FDA) earlier today issued a formal announcement that it is investigating the safety of the multiple myeloma treatments Revlimid and thalidomide.
The investigation is being carried out due to clinical trial results that suggest Revlimid may increase the risk of secondary cancer in patients taking the drug for extended periods of time.
The announcement confirms a Beacon news update last week that reported evidence that an investigation of Revlimid was underway (see related Beacon news).
Today's FDA statement says that the agency is "aware of results from clinical trials ... that have found that patients treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug."
For this reason, the FDA "is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review."
The announcement adds that the FDA recommends that patients now taking Revlimid should continue taking the drug as prescribed by their physician, and that the FDA currently believes "the benefits of Revlimid continue to outweigh the potential risks."
One somewhat unexpected development found in the FDA announcement is news that the agency also is investigating thalidomide (Thalomid) and whether it, too, may be linked to increased rates of secondary cancer. This investigation is being carried out, the FDA said in its statement, because Revlimid and thalidomide are chemically very similar to one another.
The FDA did not report or suggest, however, that the agency has any evidence at this time that thalidomide may increase rates of secondary cancer in multiple myeloma patients.
In a statement to the Beacon regarding the FDA announcement, a spokesperson for Celgene, the company that markets both Revlimid and thalidomide, said that Celgene "will continue to provide any information needed to complete the [FDA's] review and, as before, will also look toward the presentation of further data at medical meetings this summer."
More data on Revlimid and its potential link to increased rates of secondary cancer are expected to be presented at the upcoming International Myeloma Workshop in May and the American Society of Clinical Oncology meeting in June.
The full text of the FDA announcement is available at the FDA website.
A complete compilation of Beacon articles with information on the Revlimid safety controversy is available here.
Related Articles:
- Nelfinavir Shows Only Limited Success In Overcoming Revlimid Resistance In Multiple Myeloma Patients
- FDA Approves Once-Weekly Dosing And Revised Safety Information For Kyprolis
- Revlimid, Velcade, and Dexamethasone, Followed By Stem Cell Transplantation, Yields Deep Responses And Considerable Overall Survival In Newly Diagnosed Multiple Myeloma
- Two Darzalex Clinical Trials Halted; Little Impact Expected On Drug’s Use In Multiple Myeloma
- Adding Clarithromycin To Velcade-Based Myeloma Treatment Regimen Fails To Increase Efficacy While Markedly Increasing Side Effects
Dear Beacon Editorial Staff:
I would love to know "who" at FDA will be investigating and their connection to the pharmas or if they are federally employed scientists. If you have the chance to get that data sometime in the future. I would imagine that they are FDA scientists, coupled with industry researchers who are not conducting new studies but looking at existing data? Clarification on this process would be of great interest to me and perhaps some of your other readers as well.
If the FDA wants to eliminate the use of something that causes cancer, then eliminate the use of cigarettes.
The benefits of Revlimid use far outweigh the elimination of its use. I have used Revlimid for almost 3 years. I also had a stem cell transplant in July 2010. Last year, I ran the Marine Corps Marathon, and 10 days from today, I will be running the Boston Marathon. And I'm 65 years old. Thank God for Revlimid! "The proof of the pudding is in the eating."
The "proof" proverb literally says that you won’t know whether food has been cooked properly until you try it. Or, putting it figuratively, don’t assume that something is in order or believe what you are told, but judge the matter by testing it; it’s much the same philosophy as in "seeing is believing" and "actions speak louder than words". Revlimid has been tested. It works. Now let's all work towards a cure.
Cytoxan, melphalan, radiation, cisplatin etc etc are all highly mutagenic and carcinogenic. The purported carcinogenicity of revlimid and thalidomide, if any at all, is far below the carcinogenic potential of these older agents, which are still in use.
This makes you wonder how much time and energy went into finding out how safe Revlimid was during the early years of studying the long term affects before initially approving it for use....
Now that Revlimid had been used for years treating not only Multiple Myeloma, but Amyloidosis, and some other illnesses as well with a great deal of success. The FDA finds out NOW that secondary cancer development is a safety concern that should be looked into.....
How many years did they know that cigarettes caused cancer before Big Tobacco was finally told to stop so many of their practices when it came to the safety of Tobacco use....
I recently looked at a copy of Life magazine from 1944. It had an advertisement for cigarettes that said more doctors prefered this brand of cigarettes over other brandse because of a smoother taste and long lasting flavor....
I'll bet they knew about the harmful affects of cigarettes even back then, but somehow this information was not getting out to the general public....
One can't help but wonder who knows what about the safety of so many products and how Big Business plays into the decisions as to what gets out to the public and what does not......
How may lifes have been lost since the begining of time because the biggest factor of all was/is "The Almighty Dolar" ....
It makes me sick to think about what may really be going on as far as the "TRUTH GOES" ....
I had a stem cell translplant Feb/09 and have been on Revlimid ever since. I have had no problems with it whatsoever. My labs and Cat-scans have all come out great. Yes the cancer had damaged some of my nerves, but thats due to the cancer and not the revlimid. Like someone else said the good of revlimid overweighs the bad. I suppose it might also have to do with the person itself and the severity of their situation.
What information or documentaion do you have that the Cancer damaged the nerves and not the drugs used to treat it.
Your post is the first I've ever read about the Cancer causing nerve damage. Can you document any articles to back that statement.
My doctors, as well as everything I've read have always indicated that drugs such as Revlimid and especially Velcade are the real causes.
I don't doubt what you have posted, I would just like to know where this information came from.
Any information you can provive to document this would be greatly appreaciiated.
I've been on Revlimid for 3 years with great success, but but my neurapathy has gotten a lot worse. I also understand that the nerve damage from Vecade and Revlimid is permanent.
I've always been told it's the treatment and not the cancer that causes the neuropathy. Can you give any specifics ?
Thanks.....
John,
I believe if you check with your oncologist, he/she will tell you that peripheral neuropathy among myeloma patients is most often associated with the treatment that myeloma patients receive. Generally, it's either the Velcade or thalidomide that patients receive that causes the neuropathy.
However, your oncologist also will probably tell you that myeloma itself can cause neuropathy. It doesn't do it in all myeloma patients. But it can be a side effect of the disease. And, if you think about, it's not that surprising, given how the disease can change the chemistry of a patient's blood, and how that, in turn, could affect the nerves in your body.
The Wikipedia article on myeloma specifically lists neuropathy as one of the potential neurological side effects of myeloma. Here's the text of that section of Wikipedia article on myeloma; see, in particular, the last part of the paragraph:
"Neurological symptoms - Common problems are weakness, confusion and fatigue due to hypercalcemia. Headache, visual changes and retinopathy may be the result of hyperviscosity of the blood depending on the properties of the paraprotein. Finally, there may be radicular pain, loss of bowel or bladder control (due to involvement of spinal cord leading to cord compression) or carpal tunnel syndrome and other neuropathies (due to infiltration of peripheral nerves by amyloid). It may give rise to paraplegia in late presenting cases."
Hope this helps,
Terry
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