The psoriasis drug Raptiva appears linked to a condition known as progressive multi-focal leukoencephalopathy (PML), learn more about natural health alternatives for psoriasis.
It took three confirmed deaths and one suspected death before the FDA decided to issue a “Black Box” warning on the psoriasis drug Raptiva. The drug, which is still on the market, appears linked to a condition known as progressive multi-focal leukoencephalopathy (PML). PML causes brain swelling, infection, and usually, death. In all four of the reported cases, the patients had been treated with Raptiva for more than three years. The drug also has been linked with meningitis, blood infections that can affect the entire body, and invasive fungal disease.
The marketing of Raptiva appears questionable in the first place, as the drug works by suppressing the immune system, and it doesn’t take a Madame Curie to understand that when you weaken the immune system, bad things might result. The idea behind the drug centers on the fact that psoriasis occurs when the immune cells known as “T-cells” trigger irregularly and migrate to the surface of the skin, where they speed up reproduction of skin cells, causing inflammation. The result is that people suffering from psoriasis have scaly, inflamed, and itchy skin. It’s a chronic disease affecting about one or two percent of the population, and while ugly and miserable, it certainly isn’t life-threatening.
But yes, it’s annoying and distressing, and those suffering from it desperately want it to go away, and so the pharmaceutical think tank came up with the idea that by suppressing T-cell production, the itching and scaling could be controlled. Now here’s a case of incredibly myopic medical thinking. By giving those “suffering from the misery of psoriasis” Raptiva, which is administered via weekly injections, they did indeed manage to control the itching and flaking, but they also put patients at risk for developing any number of diseases, infections, and malignancies. PML, for instance, only occurs in people who have severely compromised immune systems.
When the FDA became aware that Raptiva might open the door to diseases far worse than psoriasis, it issued a black-box warning, meaning that the agency asked the manufacturer (Genentech) to add a text warning on the package insert noting that the drug can cause life-threatening infections or even death. The agency says it is now reviewing whether the drug’s benefits outweigh its problems (it’s probably worth mentioning that this, of course, comes years after the drug was certified as safe by the agency), and has recommended that medical professionals monitor patients taking the drug and also watch those who have taken it in the past for signs of neurological problems. The FDA further suggests that patients should be made aware of the potential side effects of Raptiva, but if they’re relying on the black-box warning to do the job, there may be a big problem — as studies show that drug-warning literature doesn’t replace advice coming directly from their doctor. Unfortunately, not every doctor is fully committed to complete disclosure about any given drug’s side effects.
The same day that the FDA issued its recommendations regarding Raptiva, the European Medicines Agency finished its review of the drug and recommended that it be banned across the European Union. The drug also is illegal in Canada. Meanwhile, the drug continues to rake in $120 million per year, mostly in US dollars, though the black-box warning notes that the drug may bring about “symptoms” including “weakness, paralysis, vision loss, impaired speech, cognitive deterioration, and death.” (An interesting euphemism, referring to “death” as a symptom, what? Gotta love the FDA.)
Once again, we see that an FDA stamp of approval doesn’t necessarily guarantee safety. Too many drugs have come to market bearing pedigrees which imply that they’ve been clinically tested, through peer review, and through rigorous FDA evaluation. And then after millions of patients take the drug, it proves dangerous or even deadly. Bummer! While the goal of having oversight, evaluation and testing of potentially dangerous drugs is critical — clearly something often goes astray. Here’s a reminder to look carefully at any drug offered to you. Do your own research before taking any pharmaceutical drug.
As a side note, there is another approach to dealing with psoriasis. Use Omega-3 fatty acids and proteolytic enzymes to reduce systemic inflammation, and use nutraceutical immunomodulators to regulate your immune system — boosting a weak system or calming down an overactive one. By using immunomodulators such as L-carnosine, Cetylmyristoleate (CMO), and the Transfer Factor found in bovine colostrum, you can retrain the immune system to not overreact — and without deadly side effects.