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Tecfidera (dimethyl fumarate) is a highly effective oral drug brought to the medical marketplace by Biogenic, Inc. to treat MS (multiple sclerosis). The Food and Drug Administration (FDA) approved the drug in March 2013 to prevent the relapse of MS. However, one reported case has been noted on the updated FDA drug label (December 2014) linking Tecfidera (dimethyl fumarate) taken for multiple sclerosis with progressive multifocal leukoencephalopathy (PML), life-threatening brain infection.
This is the fourth case reported to the FDA, which resulted in an increased warning of the dangerous life-threatening side effects when taking medications to treat MS. The initial three cases of PML are apparently associated with the oral medication fingolimod among patients who had suffered severe low lymphocyte count (lymphopenia). However, the fourth case happened with “a patient with only moderate lymphopenia” that has raised concerning questions about Tecfidera’s effectiveness versus its safety.
A Confirmed Case of PML
A Biogenic Public Affairs spokesperson stated that “we can confirm that we have reported a fourth case of progressive multifocal leukoencephalopathy (PML) from October 2015 associated with Tecfidera treatment in an MS patient that had experienced prolonged lymphopenia.”
Information concerning this patient’s case was documented and delivered to Canadian neurologists revealing that “the patient is a 61-year-old woman with relapsing-remitting MS [multiple sclerosis] who presented with left arm weakness and apraxia [the incapacity to perform purposeful actions because of brain damage]; the diagnosis of progressive multifocal leukoencephalopathy was confirmed on basis of clinical, MRI, and positive results of polymerase chain reaction in cerebrospinal fluid after the patient had taken [Tecfidera (dimethyl fumarate)] for 22 months.”
The patient’s lymphocyte counts fell steadily after she started taking the MS-treating medication. Her treatment was discontinued after her doctors diagnosed her with PML. While doctors believe the drug is still useful, there are potential risks of developing progressive multifocal leukoencephalopathy, especially for individuals who are already taking immunosuppressant medications to treat various conditions including lupus and rheumatoid arthritis.
How Tecfidera Works
Tecfidera (dimethyl fumarate) was only recently brought to the medical marketplace. The medication was approved by the FDA to treat relapses of MS (multiple sclerosis), a spinal cord and brain disease that at times can be extremely debilitating. Many patients with MS have ‘on-and-off’ episodes of neuropathy (tingling and numbness), weakness, and other serious nervous symptoms. Many of the symptoms associated with the disease will completely resolve within weeks or months after the start of taking the medication. However, some treated patients have reported persistent symptoms and ongoing debilitation that develops over time.
Defining Multiple Sclerosis
Multiple sclerosis (MS) is typically defined as a chronic, progressive disease that involves damaged nerve cell sheaths in the spinal cord and brain. The major symptoms associated with MS include impaired speech, numbness, blurry vision, impaired muscle coordination and fatigue. This long-lasting disease can also affect the optic nerves in the eye and cause problems with balance and other typical body functions.
The devastating disease causes a communication disruption between the body and brain. Some individuals with MS remain completely free of symptoms while others experience severe chronic long-lasting debilitating symptoms. Doctors treat multiple sclerosis with physical therapy and drugs that suppress the body’s immune system and slow the progression of the disease.
What is Progressive Multifocal Leukoencephalopathy?
This rare, but serious, progressive demyelinating disease affects the brain that often leads to severe disability or death. The infection is caused by the John Cunningham (JC) virus that usually has no symptoms until the virus is activated. Many of the common symptoms and indicators of progressive multifocal leukoencephalopathy include:
- A weakening immune system
- Clumsiness and difficulty in speaking
- Declining mental function
- Partial blindness
- Cognitive deterioration
- Death typically occurring within nine months from onset of the disease
Many people who developed progressive multifocal leukoencephalopathy at later stages of life suffered from a JC virus infection during their childhood years. However, statistics reveal that many adults who become infected with a JC virus later in life will never develop the disorder.
A JC virus can remain inactive for years or decades until the immune system becomes weakened by lymphoma, leukemia, AIDS or other disorders. This reactivation begins to multiply the virus that can eventually cause the serious disorder. However, patients can cause the reactivation of the JC virus by taking specific medications like immunomodulator drugs that are formulated to modify the immune system or immunosuppressant drugs that suppress the body’s immune system.
Many medications, including drugs that prevent transplant organ rejection or those that treat autoimmune disorders and cancer, can also reactivate the JC virus. These include medications like rituximab and natalizumab for treating multiple sclerosis and lupus erythematosus.
Tecfidera Side Effects
Every MS treatment medication prescribed by doctors can cause a side effect that could be mild or severe. However, persistent symptoms could be an indicator of a serious side effect of the drug that will not go away. The most common Tecfidera side effects experienced by patients taking the drug include:
- Allergic reactions including swollen lips, face, tongue or mouth, along with hives, welts, and difficulty in breathing
- Decreasing white blood cell count
- Liver problems that display as a loss of appetite due to indigestion, severe fatigue, symptoms of jaundice including yellowing of the whites of the eyes and skin, along with brown or dark-colored urine and abdominal pain, especially on the right side of the stomach
- Severe fatigue
- Flushing sensation that produces rash, itching or redness
- Feeling like throwing up (upset stomach)
- Wrongful death
FDA Recall Information Related to Tecfidera
Even though there are reported incidences of death associated with taking Tecfidera (dimethyl fumarate), the FDA has yet to recall the medication from the medical marketplace for the treatment of multiple sclerosis.
However, in November 2014, the Food and Drug Administration (FSA) issued a Drug Safety Communication that warned doctors and their patients suffering from MS (multiple sclerosis) and being treated with Tecfidera or its generic version dimethyl fumarate of the potential for developing a serious, but rare, PML brain infection. The warning described a patient who developed PML after taking the medication and later died. In response to the report, the FDA added the potential problematic side effect to the Tecfidera (dimethyl fumarate) drug label.
In addition, January 2017, the FDA began warning hospitals, medical center, healthcare professionals and patients of a possible link between taking Tecfidera (dimethyl fumarate) and liver injuries. At that time, at least fourteen cases involving injury to the liver had been reported to the Food and Drug Administration. In every case, the injuries were resolved within months after every patient was taken off the drug.
Drug Warning Label Changes
The FDA states that “Patients taking Tecfidera [dimethyl fumarate] should contact their health care professionals right away if they experience symptoms that concern them, such as a new or worsening weakness; trouble using their arms or legs; or changes in thinking, eyesight, strength or balance. Healthcare professionals should stop [prescribing] Tecfidera [or its generic version dimethyl fumarate] if PML is suspected.”
The report also states that the federal agency was notified by Biogen Idec, the medication manufacturer when a multiple sclerosis patient died after developing progressive multifocal leukoencephalopathy.
The report states that “the patient had taken Tecfidera (dimethyl fumarate) for more than four years. Prior to developing PML, the patient had a very low number of lymphocytes, a type of white blood cell, in her blood. Reduced lymphocyte counts can weaken the immune system, which increases the risk for [acquiring deadly] PML. It is unknown whether the low lymphocyte count contributed to the development of progressive multifocal leukoencephalopathy in this patient, or if the low lymphocyte counts are a risk factor for PML development in Tecfidera-treated patients.”
Updated European Medicines Agency Warnings
In October 2015, the European Medicines Agency updated their recommendations to minimize the potential risk of Tecfidera-treated patients developing the rare, life-threatening PML brain infection.
The agency now recommends that doctors perform “a complete blood count… before starting the treatment with Tecfidera, and every three months during treatment. Additionally, a baseline MRI [magnetic resonance imaging scan] should be available (usually within three months) as a [baseline] reference. If during treatment, the levels of lymphocytes drop to very low levels for more than six months, the doctor should consider stopping Tecfidera. If treatment is continued, the patient should be closely monitored.”
What to Do if You or a Loved One is Taking Tecfidera?
Individuals currently taking Tecfidera or its generic form dimethyl fumarate might want to speak with their doctor about undergoing an MRI (magnetic resonance imaging) scan that can detect progressive multifocal leukoencephalopathy. If the disease is identified in the scan, the doctor might consider performing a blood plasma transfusion to cycle the medication out of the patient’s blood and tissue.
If you have been taking Tecfidera (dimethyl fumarate) and developed PML, you likely have the right to demand financial compensation for the harm and damages you suffer. However, bad drug lawsuits can be highly complex and often require the skills of dedicated, competent attorney specializes in cases that involve defective medications. By filing a Tecfidera lawsuit, your lawyer working on your behalf can build the case for monetary compensation to ensure you have adequate financial means to become whole again.
Contact the Essure attorneys at the Drug Law Center today to schedule an appointment for a free initial consultation. We accept bad drug cases on contingency fee arrangements. This means no upfront fees are necessary. In addition, we offer a “No Win / No Pay” Guarantee, meaning if we are unable to successfully resolve your financial compensation case, you owe us nothing.