Raptiva recalled by the FDA

April 21, 2009

 

Today, Genentech announced that it has suspended sales of the psoriasis drug RAPTIVA in the United States due to its links to brain infections. Raptiva has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Fears | Nachawati Law Firm is currently evaluating cases on behalf of all Raptiva patients.

Fears | Nachawati Law Firm has helped victims of defective drugs and medications obtain justice and hold pharmaceutical companies that have released problematic drugs onto the market accountable.  As new medications are released, some ultimately prove to present as much danger to those who use them as they do potential cures or solutions.  When this happens, victims need an advocate to turn to in order to help them work towards moving past the situation in such a way as the law deems proper.  The defective drugs lawyers at Fears | Nachawati Law Firm work with these clients to help them achieve this end.

Unfortunately, one of those drugs that’s been recently alleged to present an unreasonable danger to those who have used them is Raptiva, a widely used medication that was formulated to help with the treatment and management of psoriasis.  The U.S. Food and Drug Administration (FDA) has recently gotten involved with this situation, and the steps the agency has taken will be detailed below.  In the meantime, you’ll also find an overview of Raptiva and the issues that surround it.

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.

 

Contact the lawyers at Fears Nachawati for free legal information concerning this recalled drug.  Toll free 1.866.705-7584.

 

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