Multiple-sclerosis drug capable of causing serious liver injury
WASHINGTON Tysabri, a drug used for the treatment of multiple sclerosis, is capable of causing serious liver injury according to Biogen Idec and Elan Corp.
The companies sent warning letters to doctors stating that they received “clinically significant” reports that patients that were treated with Tysabri were experiencing liver injury as soon as six days after their first dose, the Wall Street Journal reported.
After being taken off the market in 2005 for possible causes of brain infection, Tysabri is sold under what is called a “restricted-distribution program”, in which patients are routinely monitored for possible brain infections or other injuries.
According to Shannon Altimari of Biogen, there were about 1000 patients with liver injuries out of the 21,000 that have been treated with Tysabri as of December. The letter given by the companies urges doctors to stop treatment if they see any liver injury or jaundice.
Senate approves bill to increase spending for American Indian healthcare
WASHINGTON The Senate has approved a bill that would give $35 billion over the next 10 years to the Indian Health Service, which provides tribal health care for 1.8 million American Indians and Alaska Natives on reservations, according to published reports.
The bill would strengthen mental health programs and patient screening for cancer and diabetes, expand disease prevention programs and recruit nurses and doctors to serve American Indian populations. It would also modernize and build health clinics and increase tribal access to Medicare and Medicaid.
The Senate also approved an amendment by Sen. Gordon Smith, R-Ore., that would grant the Indian Health Service the authority to more evenly distribute funding for construction of its health facilities. Right now, funding only goes to about 10 states.
The House is expected to take a look at the bill later this year.
FDA to increase oversight of post-market medications
WASHINGTON The Food and Drug Administration has revealed a new plan called “Safety First”, which is aimed at providing more information on drugs after they hit the market, according to the Wall Street Journal.
The plan involves creating a new database listing possible side effects of drugs, along with clear schedules for following up on questions about them. Also, the FDA plans to make changes to its procedures for making certain regulatory decisions particularly those based on emerging safety worries.
The FDA’s Office of Surveillance and Epidemiology, which focuses on the safety of marketed drugs, will get some new powers. The drug safety office will get primary authority over decisions to approve drug brand names and packaging, though this change will not occur immediately. Eventually, the safety office is supposed to formally get another power as well: the ability to commission certain kinds of research, the epidemiological studies often drawn from patient databases. This could involve requiring drugmakers to do such studies, a power the FDA gained under a new law passed last year, or contracting with outside sources.
The FDA is supposed to implement a second phase to the plan, called “Safe Use,” that will focus on ensuring that drugs are used safely in the real world.