MS Patients: Try Tysabri! Sure, it may kill you, but at least it's FDA-approved and won't get you high like cannabis!
(HealthDay News) — In the latest blow to the controversial multiple sclerosis drug Tysabri, the U.S. Food and Drug Administration announced that it was slapping a new warning on the drug’s label.
In an advisory sent to health-care professionals and patients, the FDA warned that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but deadly brain infection, increases as more infusions are received.
Natalizumab (Tysabri) first received FDA approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed PML.
In June 2006, the FDA allowed the drug back on the market, but with strict conditions. According to those revised guidelines, Tysabri can only be administered by approved doctors, at infusion sites and at pharmacies that register and comply with a patient-safety program called CD Touch, designed by drugmaker Biogen Idec and approved by the FDA.
The FDA said the new action was based on reports of 31 confirmed cases of PML as of Jan. 21, 2010.
Information on the risk will also be included in the patient Medication Guide.
However, the FDA did not suggest discontinuing the drug, stating that it “believes that the clinical benefits of Tysabri continue to outweigh the potential risks.”
The drug was approved to treat Crohn’s disease in early 2008. It is also linked with liver damage.
We have a remarkable medicine for multiple sclerosis patients called cannabis. We have research showing that it relieves the symptoms of MS and may even halt or slow its progression. It has absolutely zero deadly side effects, no matter how many infusions of cannabis one takes. Yet MS patients in 36 states cannot access this medicine without facing arrest and incarceration. MS patients in 14 other states are repeatedly taunted by the opponents of medical marijuana that “anecdotes are not evidence” and “it’s not been approved by the FDA.”
Surely many patients do get relief from Tysabri but it just shocks me that the FDA’s reaction to 31 cases of deadly side effect is to slap a new warning label on the drug and call it good, especially while the prohibitionists wail about the dangers of smoked cannabis.