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Doctors report 2 cases of the deadly skin cancer developing in patients taking Tysabri
By Amanda Gardner
Posted 2/6/08
WEDNESDAY, Feb. 6 (HealthDay News) -- Almost immediately after a 46-year-old woman with multiple sclerosis received her first dose of the drug Tysabri, a mole that had been on her shoulder for years suddenly took on a dangerous new character. It turned out to be a melanoma that spread like wildfire. The woman now has just a few months to live.
At almost the same time, a 45-year-old woman who also has multiple sclerosis developed melanoma in her retina after receiving several doses of Tysabri. She had a family history of melanoma and also had atypical moles on her body; the mole on her retina went back at least nine years.
Although these are just two -- albeit dramatic -- examples, the authors of a letter in the Feb. 7 issue of the New England Journal of Medicine are cautioning doctors who care for MS patients to keep this potential risk in mind.
"Neurologists who have patients who report a family history of melanoma or have funny moles should send them to a dermatologist first. Don't just start them on drugs [Tysabri]," said Dr. John Thomas Mullen, co-author of the letter and a surgical oncologist with Beth Israel Deaconess Medical Center, in Boston.
"I can't say it's cause-and-effect definitively because it's just an observation, but the first patient had had that mole forever. She took the drug and almost instantaneously the lesion changed," added Mullen, who saw both patients.
"We don't know if the two are related right now," said Patricia O'Looney, vice president of biomedical research at the National Multiple Sclerosis Society. "There are so many people taking Tysabri, we should go forward with caution... One should always consult with their doctor and go over their personal family history and decide what is best."
Tysabri (natalizumab), a monoclonal antibody that helps treat autoimmune disorders such as MS and Crohn's disease, has had a clouded history. It first received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy.
In June 2006, the FDA allowed the drug back on the market but with strict conditions governing its use.
Just last month, the FDA approved Tysabri to treat people with a moderate to severe form of Crohn's disease.
But there is basic science to support Mullen's observations.
One of the participants in an earlier study of Tysabri had developed (and subsequently died of) a metastatic melanoma that appeared as soon as he got his first dose of the drug, Mullen said.
And in a study done before Tysabri received FDA approval, melanomas in mice that were given the drug had an increased tendency to detach from the primary tumor and spread.
Tysabari may have a dampening effect on the immune system that encourages the formation of the potentially deadly skin cancer, the letter stated.
And now that Tysabri has been approved for people with Crohn's disease, more people may be at risk, although those with no family history of melanoma and no moles probably don't need to worry, Mullen said.
"Doctors should ask for a family history of melanoma and do a quick skin check," he said. "Tysabri isn't the only drug in our arsenal. You could give the patient something else if you were concerned about that."
Shannon Altimari, a spokesperson for Biogen Idec Inc., which in partnership with Elan Corp. markets Tysabri, has confirmed that another MS patient, a man who received treatment in clinical trials prior to the drug’s FDA approval, has also developed melanoma.
However, according to him, the manufacturers of the drug have no current plans of putting the caution notice on Tysabri's label warning doctors and patients of the possible risk of melanoma in patients with atypical moles or a family history of melanoma.
Joined: May 04, 2006 Posts: 3300 Location: Mid-Michigan
Posted: Fri Feb 08, 2008 8:35 am Post subject:
I'm not sure what they're trying to prove with that article. Out of the thousands of people on Tysabri, a couple experienced melanoma and there is no strong reason to believe that Tysabri has anything to do with it?
That might be a lower incidence than you would expect in the general population.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Joined: May 26, 2004 Posts: 1337 Location: London, ON, Canada
Posted: Fri Feb 08, 2008 8:43 am Post subject: Re: Biogen has no plans to let anybody know
batpere wrote:
I'm sure Harry will not be surprised by this and it has me concerned what else they are not passing on.
Surprised...No...saddened...Yes!
A couple of people involved with MS research that I've met over the years in dealing with this lousy disease, told me that it would be highly likely that this kind of problem with Tysabri would surface over time. After all, we are dealing with a very powerful drug that alters the way the immune system works.
What makes me sad about this is that MS patients have again been subject to the roller coaster ride of yet another promising drug which has been over promoted as being great for MS but slowly becoming associated with other problems. I saw what this did to my wife Marg while she was alive and it made her totally skeptical to the MS world of medicine.
While these two cases are just observations so far, it makes you wonder what else has gone unreported with those who are using Tysabri. Biogen, like all drug companies, are loathe to report this kind of information because it can have a very negative effect on potential sales.
Let's hope that this recent problem is a very isolated situation....MS patients don't need more bad news!
Joined: May 26, 2004 Posts: 1337 Location: London, ON, Canada
Posted: Fri Feb 08, 2008 8:54 am Post subject:
Lyon wrote:
I'm not sure what they're trying to prove with that article. Out of the thousands of people on Tysabri, a couple experienced melanoma and there is no strong reason to believe that Tysabri has anything to do with it?
That might be a lower incidence than you would expect in the general population.
Bob
Bob,
I'm not sure that the people involved with the report are trying to prove anything other than what they have discovered. The very way that Biogen/Elan promoted Tysabri, introduced it and then had to pull it off the market for a period of time, has resulted in it coming under the microscope. I wouldn't be a bit surprised if Biogen's competitors in MS drugs are behind this because there is a bitter rivalry among them. In normal circumstances, we probably wouldn't have even heard about these two melanoma cases but with Tysabri's current situation, everything happening with this drug is going to be reported. Perhaps not necessarily fair but a reality, nonetheless.
Joined: Sep 11, 2007 Posts: 560 Location: southern California
Posted: Fri Feb 08, 2008 9:36 am Post subject:
This caught my eye, because my husband has had several basal cell sites removed since his dx last year (no melanoma), and beginning treatment with Copaxone. Perhaps it's just because of the scrutiny Tysabri is receiving that the connection has been made with melanoma. Would be curious to know what the data is on all CRABs patients with melanoma.
In any event, I think it would be wise for all MSers on CRABs with moles and skin anamalies to be vigilant and see the dermatologist. Immune modulation can affect many things.
interesting,
AC _________________ Husband diagnosed RRMS March 2007
20 lesions brain/spine
Copaxone, Swank, supplements, laughter
Joined: Aug 14, 2006 Posts: 98 Location: So. Calif.
Posted: Sun Feb 10, 2008 6:37 pm Post subject:
I read this article, and others like it.
Unfortunately, most of those articles do not tell the whole story, only one side of it, and failed to mention the following: "Might the drug have caused melanoma in these two MS patients? It's possible", says Timothy K. Vartanian, MD, PhD, chief of the MS division at Beth Israel Deaconess Hospital and associate professor of neurology at Harvard Medical School. Vartanian and colleagues report the two cases in a letter to the Feb. 7 issue of The New England Journal of Medicine.
"The important thing to remember is that Tysabri remains by far the most effective FDA-approved drug for treating relapsing forms of MS" stated Vartanian. "There are adverse effects associated with all medications..."
Both of the women treated by Vartanian and colleagues had existing moles. In fact, one of the women had a family history of melanoma. Her father and a brother had melanomas; both of them remain alive and well.
The report from Vartanian and colleagues does not prove Tysabri caused these patients' melanoma.
The jury is still out, considering there are over 21,000 MS patients currently on Tysabri therapy, and I am one of them, having had 17 Tysabri infusions so far, with not one single relapse nor any disease progression in over a year.
I think that any potential Tysabri patient that has a history of melanoma in their family, or has any kind of skin condition (such as moles, etc.) should be checked regularly by their dermatologist.
Just thought some here might like to see the other side of the story.
All my best, Lauren
_________________ Feel free to visit my Blog and leave me a comment, I'd love to hear from you!
It is more than obvious that Tysabri in one way or another does dampen a humans body's defense outside of the brain and spinal cord in order to preserve the wellness of the neurological tissue from inflammations (attacks).
Therefore, unfortunately for all us who take Tysabri, we must be extra careful
1) of our family history for any type on body 'malfunctions' ...
2) that we lead and preserve a very healthy life so that we dont promote any 'malfunctions' ourselves!
It is the nature of the drug to lower the immune' s system capabilities and therefore I would say there is no side of story etc etc,
POSSIBLE or it is a POSSIBILITY describes perfectly this new drug, due to the fact that you had 2.000.000 knights fighting for you ... and now you have about say 500.000 defending the nation. However, we have seen in the past 300 (Leonidas and his heroes from Thermopylae) defend the country against millions of enemies !!!
It is the best commercial TREATMENT out for R-R MS patients to lead a normal life, but that certainly does not come without its costs .... so being extra careful and maintaining a healthy and happy spirit will certainly breed these 300 to defend you from anything and anyone! _________________ an action brings..... a reaction !
Joined: Jun 26, 2004 Posts: 229 Location: Near Chicago
Posted: Sat Feb 16, 2008 2:42 pm Post subject:
I know of another case that may be somehow related to Tysabri. A good thing to consider would be, how many cases of melanoma in the general population?
That being said, I just had my 10th infusion, and so far, so good. After hearing this news though, I did schedule my first baseline dermatology checkup for Feb 20th which I had been overdue for anyway. I have several moles I'd like to be checked out just to be sure they aren't bad ones.
My Mom had skin cancerous moles removed, but I think they may have been squamous cell? I have to see if my sister remembers. _________________ Take care,
Ewizabeth
Previously Avonex, Rebif & Copaxone
RRMS
~Tysabri since 6/04/07~
Joined: Dec 27, 2007 Posts: 29 Location: Australia
Posted: Mon Mar 31, 2008 3:08 am Post subject:
Interesting reading, all of your comments! I would like to say thankx Lauren for your possitive words, as you may remember I am about to start Tysabri & I can tell you I am terrified So the I guess the night before I go to my Neuro isnt really a good time to be getting on this site & reading all this stuff because I am already worried, but we do have to be informed as much as possible so thanks to you all again!
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So the I guess the night before I go to my Neuro isnt really a good time to be getting on this site & reading all this stuff because I am already worried, but we do have to be informed as much as possible so thanks to you all again!