Again, a defective drug unleashed by a pharmaceutical company may be endangering many Americans. In this case it is Raptiva, a psoriasis drug which could cause a serious brain infection and even result in death.

The Food and Drug Administration on Feb. 19 issued an advisory citing three confirmed cases -- and a possible fourth case -- of persons being diagnosed with progressive multifocal leukoencephalopathy (PML) after they were treated with Raptiva.
The FDA indicated that all four patients were treated with Raptiva for more than four years, none were getting treatments other than Raptiva to suppress the immune system, and three of the patients have died.

The FDA also reported it will take "appropriate steps" to make sure that Raptiva's risks do not outweigh its benefits. The FDA itself approved use of Raptiva in 2003 for treatment of moderate to severe plaque psoriasis.

Raptiva is manufactured by California-based Genentech, a pharmaceutical giant which proclaims itself "among the world's leading biotech companies." Founded in 1976, Genentech provides biotechnology products such as Raptiva, which adults with psoriasis inject weekly to suppress infection-fighting T-cells in their immune systems. Such T-cells can lead to the inflammation of the skin associated with psoriasis, an incurable condition that afflicts 6 to 7 million Americans.

While Raptiva can interrupt a patient's cycle of psoriasis, it simultaneously reduces patients' immune-system defenses. In doing so, the drug "increases a patient's susceptibility to infections," the FDA said.

In October, Genentech altered Raptiva's packaging with a "black box" warning to indicate it could produce risks of life-threatening infections, such as PML. Other infections which Raptiva might cause include lymphomas, malignant melanoma, non-melanoma skin cancer and non-cutaneous solid tumors.

Raptiva isn't Genentech's first brush with PML. Recently, Genentech also cited a case of a rheumatoid arthritis patient dying from PML after using its drug Rituxan.

In Europe, officials are taking a more aggressive stance against Raptiva. The European Medicines Agency urges that no new Raptiva prescriptions be issued and that patients already on the drug consult their physicians for alternatives. The agency also asked the European Commission to make its urged halt on prescriptions legally binding.

The agency also stressed that patients already on the drug should be monitored closely for symptoms of neurological infection.

Among people who suffer from PML, 80 per cent die within six months of the onset of infection, according to the National Institutes of Health. Even persons who survive PML may have "severe neurological disability," the NIH says. Thus, the results of PML's assault of the brain and central nervous system are death in most cases and permanent disability in many others.

For that reason, the European Medicines Agency believes the drug's risks outweigh its benefits.

If you or a loved one uses Raptiva and are concerned about possible infection, consult a physician immediately. For your financial security in the face of such a calamity, also consider alerting a defective drug lawyer with Jim S. Adler & Associates. Submit a free case review form online and an Adler Raptiva defective drug attorney can help determine if you should pursue a Raptiva lawsuit.

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