Raptiva® Recall: Genetech Withdraws Psoriasis Drug Raptiva® (Efalizumab) from U.S. Market
After months of the Food and Drug Administration (FDA) monitoring the health risks of those taking Raptiva® (efalizumab), Genetech, the drug’s manufacturer, voluntarily withdrew it from U.S. markets. Genetech, a biotechnology company based in South San Francisco, California, announced the phased withdrawal on April 8, 2009. From now until June 8, 2009, both the FDA and Genetech are recommending that healthcare providers and psoriasis patients currently taking Raptiva® work together to seek alternative treatment options. After June 8, 2009, Raptiva® will be unavailable in the U.S.—it has been unavailable in both Europe and Canada since February 2009.
Raptiva®—Risky Immunosuppressant Therapy for Plaque Psoriasis
Raptiva®, a once–weekly injection used to treat adults with moderate to severe plaque psoriasis, works by suppressing the immune system to reduce psoriasis flare–ups. Psoriasis is caused by the abnormal growth of new skin cells resulting in inflamed patches of thick, red, scaly skin. Most often, it appears on the scalp, knees, elbows and/or trunk. It may be limited to a few spots or it may involve larger areas of the body. The most common form, plaque psoriasis, affects approximately 2.3 million Americans. The inflamed patches of skin, “lesions”, have silvery white scales. Neither form is contagious.
Since there is no known cure for psoriasis, drugs like Raptiva® are used to control the inflammation by suppressing the body’s immune system to give relief to the psoriasis patient. Raptiva® suppresses T–cells, blood cells that fight infection, in the immune system. Activated T–cells migrate to the skin causing inflammation. Raptiva®, by suppressing the T–cells, helps alleviate the inflammation. In suppressing the immune system, however, the person taking Raptiva® has an increased risk of developing a serious infection.
Risks and Side Effects of Raptiva® Including Progressive Multifocal Leukoencephalopathy (PML)
For patients taking Raptiva® there is an increased risk of developing progressive multifocal leukoencephalopathy (PML), a factor which prompted Genetech to initiate the drug’s recall. PML is a progressive neurological disease caused by the activation of the John Cunningham (JC) virus that affects the central nervous system. In approximately 80% of healthy adults, the JC virus is present in a latent (nonactive) form. Although it is not certain why it becomes active and causes PML, it seems to activate in patients whose immune systems are severely weakened or compromised. Abnormal T–cells may play an important role in the activation of the latent JC virus.
Although the development of PML is rare in those taking Raptiva®, it has increasingly been associated with those individuals who have taken Raptiva® for a long period of time. There is no known effective treatment or prevention of PML. The symptoms of PML may include:
- Confusion
- Dizziness or loss of balance
- Difficulty talking or walking
- Vision problems
Other serious side effects of Raptiva® include:
- Anemia, a condition developing from the lack of healthy red blood cells, which may be indicated by:
- Dizziness upon standing
- Weakness
- Jaundice
- Thrombocytopenia, a condition where low platelet (thrombocyte) count inhibits the blood’s clotting
mechanisms, which may result in severe bleeding. Other symptoms may include:
- Bruising
- Bleeding gums
- Pin–point sized red/purple dots under the skin
- Nervous system disorders indicated by numbness, tingling or weakness in the arms, legs, or face
- A worsening of the patient’s psoriasis
If you are currently taking Raptiva® and experiencing any of the above symptoms, please seek medical attention or contact your healthcare provider immediately.
FDA’s Raptiva® Timeline
The FDA first approved Raptiva® in October 2003 after clinical trials involving 2,764 patients. Of the patients participating in the clinical trial:
- 2,400 were treated for 3 months
- 904 were treated for 6 months
- 218 for one year
During that time, no incidences of PML were reported.
On October 16, 2008, five years after its initial approval, Raptiva®’s approved
label was updated by
the FDA to include the warning of the potential
of developing life–threatening infections such as PML.
The FDA stated, “Safety concerns drove
labeling changes.
” The FDA also directed
Genentech to develop a Risk Evaluation and Mitigation Strategy (REMS).
The REMS was to make sure those patients
who were currently taking or who might be considering the drug as part of their psoriasis therapy received
the health risk information.
On February 19, 2009, the FDA issued a Public Health Advisory. In it, the FDA advised both patients and healthcare providers prescribing the drug of the potential risk of developing PML while taking the drug Raptiva®. The Advisory came on the heels of the FDA receiving a report of three confirmed cases of PML and one possible case directly attributable to the use of Raptiva® to control psoriasis. The psoriasis patients were between 47–73 years of age and had been treated for psoriasis by Raptiva® for more than three years. Two of the confirmed cases died as well as the one possible case.
On March 13, 2009, the FDA approved a Medication Guide for Raptiva®, including more information regarding PML on the label.
Finally, after weighing the risks versus the benefits of keeping the drug on the U.S. market as a viable treatment for moderate to severe psoriasis, Genetech voluntarily began a phased withdrawal of the drug on April 8, 2009.
FDA and Genentech’s Recommendations Regarding the Use of Raptiva® During the Phased Withdrawal
Both the FDA and Genetech are recommending that healthcare providers refrain from prescribing Raptiva® to new psoriasis patients. For existing psoriasis patients, healthcare providers are being asked to contact those who are currently using Raptiva® and discuss which alternative therapy may be the most effective for them.
The FDA recommends that Raptiva® patients work with their healthcare provider rather than abruptly discontinuing the use of Raptiva®. If a patient stops using Raptiva® abruptly, they may experience a flare–up of their psoriasis. It is currently estimated that 2,000 patients with chronic plaque psoriasis are receiving Raptiva®. Approximately 46,000 have been treated since its approval. If you are currently taking or have taken Raptiva®, your prescribing healthcare professional should continue monitoring you for the neurologic symptoms of PML even after the use of Raptiva® is discontinued.
If you or someone close to you has experienced side effects from Raptiva®, you or your healthcare provider may report them to the FDA’s MedWatch program. The MedWatch program may be contacted through:
- The MedWatch toll–free number at 800–FDA–1088 (800–332–1088)
- Their mailing address at MedWatch, HF–2, FDA, 5600 Fishers Lane, Rockville, MD 20852–9787
- Their online form the MedWatch Online Voluntary Reporting Form.
Your Legal Options If You or A Loved One Have Developed a Life–Threatening Condition from Using Raptiva®
The experienced attorneys at Brayton Purcell are currently evaluating Raptiva® cases. If you, a loved one, or someone you know, has taken Raptiva® and developed either PML or another life–threatening disease, please contact our attorneys and they will discuss your legal options with you free of charge.