RAPTIVA,a medicine given by injectionused to treat adult patients (18 years or older) with moderate to severe plaque psoriasis, may cause life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.
The FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight these risks.
In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.
Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.
Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.
This release comes at a time when we await the Supreme Courts decision on Wyeth v. Levine that could determine whether federal regulation can block patients from suing drug makers in state courts. The question before the court is whether the Food and Drug Administration’s approval of drug labels should knock out state lawsuits that contend the labels did not contain adequate warnings.
