Raptiva

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April 8th, 2009
Genentech announced that is was suspending sales of the psoriasis drug RAPTIVA in the U.S. due to its links to brain infections. It has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML).

Recalled Psoriasis Drug Raptiva Linked to Dangerous Side Effects

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Raptiva’s History and Intended Use

Raptiva is manufactured by Genentech, Inc. and was originally approved for distribution by the FDA in 2003. Its intended use was to help those who suffered from psoriasis manage the disease more comfortably. For a time, Raptiva proved to be successful, but recent reports have shown that several serious and sometimes grave side effects followed its use.
According to the National Psoriasis Foundation, Raptiva works by, “blocking the activation of certain immune cells called T cells, and the migration of those cells into the skin. T cells are a type of white blood cell in the body; in psoriasis, once these T cells are mistakenly activated, they can trigger inflammation and other immune responses and fuel the development of psoriasis lesions.
By blocking T-cell activation and the movement of these cells into the skin, Raptiva interrupts the cycle of psoriasis, leading to improvement in symptoms for many people who take it.”

Raptiva’s Side Effects

After a few years on the market, disturbing reports of side effects believed to have been brought about by Raptiva began to surface. Each of these problems reported are extremely serious in nature, and each is briefly described below.

Viral Meningitis

Viral meningitis is a serious, but rarely fatal disease that infects the fluid in the spinal cord and the fluid that surrounds the brain. It can only be diagnosed with a spinal fluid tap, and symptoms include:

Fever
Headache
Stiff neck
Fatigue

Bacterial Sepsis

Bacterial sepsis is more of a medical term that describes what happens when bacteria invades a person’s bloodstream and causes serious infections in organs such as the kidneys or lungs. Sepsis can be treated with medication, but it’s also possible that a patient can die from this condition.

Invasive Fungal Disease

Invasive fungal disease is a condition that could actually occur in several different ways, depending on the bacteria involved and the parts of the body that are harmed. Some of these bacteria can be treated with medication, but others are extremely difficult to handle.

Brain Infection - Encephalopathy

Encephalopathy means an infection that affects the brain, as stated above. Unfortunately, there are innumerable symptoms that could present themselves when this condition strikes, as different parts of the brain affected will lead to different reactions by the body.

Lymphoma

Raptiva has also shown a tendency to heighten the risk of contracting cancers such as lymphoma, which is a form of cancer that attacks the lymph nodes. Warning signs of lymphoma include pain and/or swelling of the neck, unexplained weight loss, fever, night sweats and itchiness in several areas of the body. While lymphoma can be treated, like any other cancer, it can also be fatal.

PML (Progressive Multifocal Leukoencephalopathy)

Progressive Multifocal Leukoencephalopathy (PML) is a very rare disease that, according to the National Institute of Neurological Disorders and Stroke, “progressive multifocal leukoencephalopathy (PML) is caused by the reactivation of a common virus in the central nervous system of immune-compromised individuals.”
Those who take Raptiva are under this cloud of risk, and symptoms of PML include:

Clumsiness
Progressive weakness
Visual problems
Difficulty with speech

Unfortunately, since PML affects the brain, the symptoms can be quite diverse and therefore very difficult to diagnose.

Death and the FDA’s Involvement

As noted above, many of the side effects allegedly linked to Raptiva can lead to the death of patients. Specifically, three deaths of Raptiva users are what prompted the FDA to get involved. All of them suffered from PML. The FDA required Genentech, Inc. to affix a “Black Box” warning to all labels of the medication that clearly state the dangers associated with Raptiva.

Take Action

If you or someone you love has suffered as a result of using Raptiva, you need to find out more about your legal rights. Contact a defective drugs lawyer today to schedule a free initial consultation and to get the process of holding those responsible for the damage caused accountable.

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FDA Statement

FOR IMMEDIATE RELEASE
Statement
April 8, 2009

FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

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