Tysabri Brain Injury
Tysabri is an intravenously administered drug that was approved by the FDA in 2004 for the treatment of multiple sclerosis. It was pulled from the market just one year later following reports linking it with the development of a rare, but serious, viral brain infection called progressive multifocal leukoencephalopathy (PML).
This potentially fatal brain infection was reported to have affected only a small number of Tysabri patients, so the drug was reintroduced to the marketplace in 2006. While no additional reports of PML have surfaced since the reintroduction of Tysabri, the FDA has been monitoring the drug closely as part of a strict safety program.
Tysabri Liver Injury
The resurgence of Tysabri was furthered in January 2008 when the drug was approved by the FDA for the treatment of Crohn’s disease. However, in February 2008, Tysabri again found itself at the center of controversy following reports linking the drug with liver problems.
Co-marketers of the drug Biogen Idec and Elan have stated that Tysabri-related liver damage affects fewer than one out of every thousand patients, though the FDA is warning healthcare professionals and patients of the risk. The co-marketers of Tysabri have also reported that the injuries have not been so severe that they required transplantation. The FDA maintains that the damage could potentially result in liver death.
Patients taking Tysabri are advised to consult with their healthcare provider immediately to determine an appropriate course of action. Early signs of liver damage include a yellowish discoloration of the skin (jaundice), which requires immediate medical attention.
Tysabri (natalizumab) is a prescription drug used in the monotherapeutic treatment of multiple sclerosis (MS). Tysabri is administered directly into the bloodstream every 28 days via intravenous infusion.
In January 2008, the FDA approved Tysabri for the treatment of Crohn’s disease. Patients who have not had success with other treatments may benefit from Tysabri; however, patients who do not see an effect within three months must discontinue treatment.
The approval of Tysabri for the treatment of Crohn’s disease is expected to further the financial success of the drug. Fourth quarter sales of Tysabri totaled $129 million in 2007.
If you or a loved one has suffered a Tysabri brain infection or liver injury, you may be entitled to receive compensation for your pain and suffering. Drug manufacturers are required to fully evaluate the safety and efficacy of their products prior to marketing them for use by the general public. Failure to adequately measure any side effects associated with use of a drug is considered negligence.
The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. The lawyers and staff representing Aylstock, Witkin, Kreis & Overholtz are adept at dealing with a wide variety of injuries caused by various drug defects and side effects. Contact AWKO Law today at (850) 916 7450 to get information regarding your rights as a Tysabri injury victim.