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Friday, February 20, 2009
Psoriasis Drug May Cause Brain Infection
The Food and Drug Administration has confirmed that three cases, and a possible fourth, of people diagnosed with progressive multifocal leukoenchephalopathy (PML) were caused by the psoriasis treatment drug Raptiva. Three of the four patients have died, and none of the four were taking any treatment that might have suppressed the immune system.
Raptiva is a drug injected once a week for adults who suffer from moderate to severe cases of plaque psoriasis, the most common type of psoriasis. Research has shown psoriasis is caused by a disorder in the immune system, which in turn causes a type of white blood cell called T cells to abnormally trigger an inflammation in the skin. This then causes raised patches on the skin, which are red and can be scaly, itchy, or burn. Raptiva suppresses the T cells and keeps psoriasis from forming.
PML is a disease that can cause severe neurological problems for those who survive. In 80 percent of cases, the victim of this disease is dead within six months.
In October, the FDA told Raptiva’s manufacturer, Genentech, to come up with a risk evaluation and mitigation strategy (REMS), which includes a guide on educating patients about the risks of the drug. Raptiva’s label was also revised at this time highlighting the chance of PML, as well as other life-threatening infections. However, it wasn’t until yesterday that the FDA decided to take “appropriate steps” to ensure those taking Raptiva were not exposing their selves to overwhelming risks.
The FDA also said patients will be informed about the symptoms of PML and health care professionals will be told to monitor Raptiva patients for signs of PML. Furthermore, the FDA stressed that no patient who is taking Raptiva should quit taking the drug without first making an appointment with their doctor.
The European equivalent of the FDA, the European Medicines Agency, having seen the same reports, has decided to recommend that no more Raptiva prescriptions be written for patients of psoriasis, and that those already on it talk to their doctor about an alternative medicine.
If your loved one has developed an illness by taking a drug meant to help them, please contact the product liability attorneys with the Cochran Firm to schedule an initial consultation today.
Raptiva is a drug injected once a week for adults who suffer from moderate to severe cases of plaque psoriasis, the most common type of psoriasis. Research has shown psoriasis is caused by a disorder in the immune system, which in turn causes a type of white blood cell called T cells to abnormally trigger an inflammation in the skin. This then causes raised patches on the skin, which are red and can be scaly, itchy, or burn. Raptiva suppresses the T cells and keeps psoriasis from forming.
PML is a disease that can cause severe neurological problems for those who survive. In 80 percent of cases, the victim of this disease is dead within six months.
In October, the FDA told Raptiva’s manufacturer, Genentech, to come up with a risk evaluation and mitigation strategy (REMS), which includes a guide on educating patients about the risks of the drug. Raptiva’s label was also revised at this time highlighting the chance of PML, as well as other life-threatening infections. However, it wasn’t until yesterday that the FDA decided to take “appropriate steps” to ensure those taking Raptiva were not exposing their selves to overwhelming risks.
The FDA also said patients will be informed about the symptoms of PML and health care professionals will be told to monitor Raptiva patients for signs of PML. Furthermore, the FDA stressed that no patient who is taking Raptiva should quit taking the drug without first making an appointment with their doctor.
The European equivalent of the FDA, the European Medicines Agency, having seen the same reports, has decided to recommend that no more Raptiva prescriptions be written for patients of psoriasis, and that those already on it talk to their doctor about an alternative medicine.
If your loved one has developed an illness by taking a drug meant to help them, please contact the product liability attorneys with the Cochran Firm to schedule an initial consultation today.
posted by Benjamin A. Irwin at 12:02 PM
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