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Raptiva® is a psoriasis treatment that works by suppressing immune system responses related to psoriasis outbreaks. However, Raptiva® can also create a generalized immune system suppression that increases the risk of dangerous--even deadly—infections, including a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML).
Raptiva-related Infections
In October 2008, the label for Raptiva® was changed to add a Black Boxed warning, the strongest warning that the FDA can give, to warn of the risks of life threatening infections, including:
- PML
- Bacterial sepsis (blood infection)
- Viral meningitis
- Invasive fungal disease
PML is a rare disorder of the brain that can lead to paralysis and death.
On February 19, 2009, the FDA issued a public health advisory warning patients taking Raptiva® of a possible connection between Raptiva® and PML, a fatal disease. According to the FDA, there have been three confirmed cases of PML resulting in death and one possible case of PML in people using Raptiva®. As a result of these alarming reports, the European regulators have recommended a hold be placed on sales of Raptiva®.
The FDA has directed Genentech, Inc., the manufacturer of Raptiva®, to develop a Risk Evaluation and Mitigation Strategy as a means for ensuring that patients receive risk information about Raptiva®.
Any minor infection has the potential of becoming a serious condition for people undergoing treatment with Raptiva®. Even common conditions like pink eye (conjunctivitis), strep throat, or vaginal yeast infections have the potential to create life-threatening conditions and should be monitored closely and treated aggressively for people using Raptiva®.
Symptoms of Dangerous Raptiva®-Related Infection including PML
You should be aware of and monitor symptoms of any infection when using Raptiva®. The FDA also stresses that you should look for symptoms of specific dangerous conditions that have been linked to Raptiva use, such as:
- PML symptoms: confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems
- Anemia symptoms: dizziness upon standing, weakness, and jaundice
- Thrombocytopenia (low platelet count) symptoms: bruising, bleeding gums, small red or purple dots under the skin
- Nervous system disorder symptoms: sudden onset of numbness, tingling, or weakness in the arms, legs, or face
If you notice any of these symptoms, you should contact your health care provider immediately for treatment.
Permanent Immune System Suppression by Raptiva® in Children under 18 Years Old
Raptiva® is not approved for use in children under 18 years of age because some studies indicate that Raptiva® use by juveniles may lead to a permanent suppression of the immune system. It is not currently believed that this is a risk for adults, but long-term use data is not available.
Consequences of Raptiva® Use
If you suffer a severe infection as a result of Raptiva® use, you may experience some or all of the following:
- Expensive prescriptions
- Hospitalization
- Long term health care
- Permanent nervous system damage
- Disability and diminished quality of life
- Death
To ensure that you receive the compensation you deserve for your injuries, contact the experienced product liability lawyers at Schlichter, Bogard & Denton. We fight for the rights of those injured as a result of using Raptiva® in all 50 states. Contact us to Schedule a free, no-obligation Raptiva® injury consultation today.