If you suffer from either ulcerative colitis or Crohn’s disease and your doctor wants to tell you about an experimental new drug, called Entyvio, as a treatment option, think carefully before you give the go ahead. There are some things you should know first… and they’re things that your doctor may not even know about.
We’ve been here before…
Back in December, the American Food and Drug Administration (FDA) announced that it was very alarmed about the dangers of Entyvio. So much so that it wondered if its risks could possibly outweigh the benefits.
The FDA considered restricting the use of Entyvio and there was even talk about a black box warning… trial data showed that the drug didn’t succeed in putting patients in remission after 6 weeks of treatment and it carries the risk of “liver injury that may lead to death” or require a liver transplant, as well as allergic reactions and infections.
However, as if by magic, all those concerns vanished by the end of May 2014 when the FDA made a 180 degree turn-around and approved this risky treatment for ulcerative colitis and Crohn’s disease.
The big worry is that Entyvio works just like Tysabri – a multiple sclerosis drug that was pulled from the market in 2005 because it triggered a rare virus that attacks the brain.
This deadly viral brain infection is called progressive multifocal leukoencephlopathy (PML) and back in 2005 the FDA put all Tysabri drug trials on hold when several patients came down with PML.
PML is a rare and usually fatal disease that slowly but surely destroys the brain’s protective nerve coverings. When the FDA allowed Tysabri back on the market just a year later, it put all sorts of precautions in place. Things like required MRI scans of the brain, enrolment in a special safety programme, and careful evaluations of people taking the drug 3 times a year. The agency also added a black box warning about PML.
The really scary part is that the FDA fears that Entyvio might carry that very same PML risk. Shortly after its approval, the FDA said there is still “uncertainty” about the risk of this deadly brain infection.
If you think the FDA asked Takeda Pharmaceuticals, the makers of Entyvio, to put the same safety measures in place as it did for Tysabri, you’re in for a big surprise.
Takeda took extra care of patients while they conducted trials on Entyvio. Patients were examined before, during and after they were given the drug. A panel of PML experts looked for any potential cases of the brain virus. Patients had to give their “informed consent” and were educated about the risks.
But now that the drug has been approved all those precautions are history. All the FDA asks is for doctors and nurses to “monitor patients” taking this new drug. There’s no black box warning and no special safety programme like there is for multiple sclerosis patients taking Tysabri.
There are always unknown risks that come with all new drugs, but with Entyvio it looks like we already have a good idea what those risks may be – and they’re terrifying.
Bear in mind all the material in this email alert is provided for information purposes only. We are not addressing anyone’s personal situation. Please consult with your own physician before acting on any recommendations contained herein.