The Real Impact of FDA Raptiva Removal

Washington, DCThe recent decision to suspend Raptiva by its manufacturer due to concerns over Raptiva and PML (progressive multifocal leukoencephalopathy) represents a bit of good news for critics who had reservations that Raptiva's risks outweighed the benefits. The US Food and Drug Administration (FDA) has been closely monitoring Raptiva for a while now. However the precursor to Raptiva FDA removal from the US market is Health Canada, which ordered the suspension of Raptiva in that country in February.

Health Canada took its cue from the European Medicines Agency (EMEA), which had determined previously that the benefit/risk in the approved indication for Raptiva had become unfavorable following safety concerns.

Three virologically confirmed cases and one suspected case of PML, a rare but potential deadly brain disease, had been reported in patients with chronic plaque psoriasis who had been continuously treated with Raptiva for three or more years. The drug, efalizumab, is associated with other serious side effects including Guillain-Barré and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections.

Thus, Health Canada and the EMEA were first off the mark and weeks ahead of the FDA.

Nonethless, Raptiva will no longer be available after the second week of June. Doctors have been advised to monitor their psoriasis patients closely upon stopping Raptiva, for signs of the skin condition returning.

The latter could be a huge issue for acute psoriasis patients. That's because for psoriasis, Raptiva worked extremely well. Many Raptiva patients have posted online to report their plaque psoriasis had been reduced from a widespread scourge, to practically non-existent thanks to the intervention of Raptiva.

In this way, the injectable drug worked extremely well and for many, well beyond their initial hopes. Patients concerned with the potential for Raptiva PML were buoyed by the chnace to live, to work, to appear in public without large patches of unsightly psoriasis. No longer was there a need to wear long-sleeved shirts on a hot day.

Critics wonder if the manufacturer had any inkling, either prior to or at actual approval for Raptiva in 2003, that progressive multifocal leukoencephalopathy was a potential threat. It should be noted that none of the documents submitted to the FDA supporting approval for Raptiva in 2003 (and posted on the FDA's website), appear to make any mention of PML as a possible adverse reaction.

The rub is that not only will the drug no longer be available, but there is the possibility that psoriasis will return with even greater vengence once Raptiva is stopped.

That's what happened to Kathy, a Raptiva patient for two years. After Genentech issued updated warnings last fall about the potential for PML, Kathy's doctor decided to stop Raptiva, "…cold turkey—no slow come-down off the drug," she writes.

"While I understand the potential and appreciate the concern and care of my physician, my heart is breaking. This is the very first drug that has ever helped my psoriasis. I went from about 65% coverage to a few tiny spots (with Raptiva).

"It has been three weeks now and I have broken out into the worst psoriasis outbreak ever. For the first time, I have gutterate (which I never had before), in places that I have never heard of. In the last day or two, I am also getting a return of the regular psoriasis."

For now, Kathy has to make do with topical medications.

"I also know that my immune deficiency has been increased in severity. I have to avoid anyone (who) is ill for fear that I will catch whatever they have. I have tried for a month now to get rid of a sinus infection and have been told that other illnesses could also occur."

The removal of Raptiva from the market could prove to be a huge emotional issue for many psoriasis patients, many of whom had suffered from psoriasis their entire lives and had found little relief until Raptiva came along. The emotional despair on the part of some patients, having been given a new lease on a life suddenly free from psoriasis, may become debilitating once Raptiva is stopped and psoriasis symptoms return—often more serious than previously encountered. Supporting documents dating back to 2003, prior to Raptiva's FDA approval, show that psoriasis symptoms returned aggressively in some trial participants when the Raptiva was stopped.

Assuming the absence of an effective alternative, what is a psoriasis patient to do?

It is interesting to note that Genentech is not expecting a significant negative impact to its bottom line by suspending and removing Raptiva from the market. The concern over progressive multifocal leukoencephalopathy and its ability to attack many parts of the brain at once is a worthy reason to suspend Raptiva for good.

Three people have died.

Kathy is understandably worried. "It scares me to think of what possible damage to MY brain has taken place in the two years I have been on this medication." However she is also loath to think that her psoriasis may never disappear as effectively as it did when she was on Raptiva. The issue may leave Kathy and many like her pining for an alternative that may never come.

At the end of day, few drugs will deliver the intended benefit without the occurrence of adverse effects. In the case of Raptiva and PML, however, progressive multifocal leukoencephalopathy is an adverse reaction that could not be ignored. Thus Genentech has now undergone Raptiva FDA removal from the market. That doesn't help the Raptiva patient, who can look forward to several weeks of instability pertaining to their immune system once Raptiva is stopped—not to mention the risk of PML and the return of psoriasis symptoms. Regardless of whether you have been harmed while on Raptiva, or as the result of discontinuing the drug, a call to a Raptiva and PML attorney would be prudent.