The National Multiple Sclerosis Society states that Tecfidera’s, formerly known as BG-12, mechanism of action is not known, but it is theorized that Tecfidera inhibiting the immune system helps with MS treatment.
Person Taking Tecfidera Dies of Progressive Multifocal Leukoencephalopathy
According to the National Institute of Neurological Disorders and Stroke, PML is a rare disease of the white matter of the brain caused by the polyomavirus JC and associated with individuals with compromised immune systems. The patient who developed PML had been on Tecfidera for over four years and had suffered from lymphopenia, which is a risk factor for developing PML, according to Reuters.
The National Institutes of Health report the symptoms of PML include:
- Vision problems
- Memory loss
- Loss of coordination/clumsiness
- Loss of language ability
- Weakness of the arms and legs
MultipleSclerosis.net reports that the symptoms of PML can mimic the symptoms of multiple sclerosis, making it difficult to diagnosis in MS patients. The National Institute of Neurological Disorders and Stroke reports that mortality rate is between 30 and 50% and that those who survive may be left with permanent neurological disabilities.
Drugs Similar to Tecfidera Have Been Associated With PML
The National Multiple Sclerosis Society reports that a drug similar to Tecfidera, called Fumaderm, active ingredients dimethyl fumarate and fumaric acid ester, has been used in Europe for decades in the treatment of psoriasis.
Fumaderm and Psorinovo, dimethyl fumarate with copper, have been associated with PML in psoriasis patients in Europe, according to MultipleSclerosis.net. The New England Journal of Medicine has case reports of patients on these drugs, fumaric acid and Psorinovo, developing progressive multifocal leukoencephalopathy after having been on these medications for several years.
FiercePharma reports the maker of Tecfidera, Biogen Idec, removed a previous MS drug, Tysabri, from the market for a period of time after patients taking it developed PML.
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About The Fatal Accident
According to inForney.com, the accident occurred on January 6th, 2011 in Kaufman County, Texas.
The Kaufman Independent School District bus, was making its routine stops on the outskirts of Kaufman, Texas. The bus stopped on State Highway 34 near Farm-to-Market 2728, where 7-year-old Nicholas Garza exited.
While attempting to cross the street, Garza walked in front of the bus when he was struck by Salvador Hernandez of Terrell, Texas, resulting in his death. One of Garza’s siblings witnessed the accident.
The school bus’s flashing red warning lights and stop arm were out at the time of the accident. Hernandez immediately stopped the bus after the accident occurred.
Authorities say no alcohol or drugs were involved. Hernandez provided a blood sample and was cooperative.
Driver Takes Plea Deal
On February 24, 2011, the second-degree felony charge was brought on by a Kaufman County grand jury. Hernandez was arrested for involuntary manslaughter. He was held on a $200,000 bond and was released after posting it.
In the last three years, the defense and the state have met 15 times to negotiate plea deals and the case factors.
Judge B. Michael Chitty is presiding over the Kaufman County’s 422nd District Court, where Hernandez pleaded guilty on Wednesday, October 29th 2014.
Hernandez pleaded guilty, as part of a plea agreement, to a lesser charge of criminal negligent homicide with the use of a vehicle as a deadly weapon. Before the plea agreement was presented to Hernandez, KISD, Garza’s parents, and foster parents were informed about the plea agreement.
The Kaufman County District Attorney’s Office Prosecutor, Marc Moffitt, commented that when deciding on a plea agreement, “all the factors come into play.” The plea agreement allowed Hernandez to admit guilt to a third-degree felony rather than a second-degree felony.
Hernandez was fined $2,000 and must pay court fees of $290. He was also sentenced to 40 hours of community service and five years deferred adjudication.
Hernandez is still facing a civil suit, however, for wrongful death and bystander damages due to loss of companionship and trauma, among other claims. The suit was filed in June 2012 by the Garza family and co-defendents: KISD, Garza’s fosterparents, and the foster program, and is seeking over $1,000,000.
The lawsuit is on the behalf of Nicholas Garza and his siblings, one who witnessed the death and two others who later saw the accident
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The FDA has recommended limited use of the drug Edoxaban produced by the Japanese pharmaceutical company Daiichi Sankyo Co. Edoxaban is a daily anticoagulant that inhibits Factor Xa, a protein that plays a major role in blood clotting.
About the FDA’s Decision
Following revision by the U.S. Food and Drug Administration, patients taking Edoxaban for atrial fibrillation are advised to limit their dosage to 60 mg, although it would be ideal to limit the drug to only those patients with abnormal kidney function
The 60 mg dose of Edoxaban outperformed its counterpart warfarin (a widely used anticoagulant) in the treatment of mildly renally impaired patients but was significantly worse than warfarin in its treatment with individuals with normal renal function.
Reviewers said: “Although the ... overall findings support effectiveness, efficacy outcomes by baseline renal function have potential implications for approval or labeling."
Effectiveness of Edoxaban in Treatment
A late-stage clinical trial of Edoxaban released last year demonstrated that it was safe and more effective than warfarin in preventing strokes and blood clots, and was associated with much less major bleeding (this is the biggest risk with blood thinners).
Warfarin has been marketed for over 50 years and is effective in preventing strokes but needs a supplemental use of blood level monitoring, dosage adjustments, and dietary restrictions.
Reuters says: “Savaysa, which is the proposed brand name for edoxaban in the United States, is also undergoing regulatory review for the treatment of venous thromboembolism (VTE).”
If approved, Edoxaban would compete with the following brands in its relative market:
- Xarelto (sold by Bayer AG and Johnson and Johnson)
- Eliquis (sold by Bristol-Myers Squibb Co and Pfizer Inc.)
- Pradaxa (made by privately held Boehringer Ingelheim)
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