Boston Scientific as well as some medical device competitors are under federal investigation for possible off-label and unapproved marketing of their bile duct stents. The US Justice Department is investigating whether the company marketed the stents for off label use, a violation of FDA rules. The FDA met with Boston Scientific last March to discuss their concerns over possible off-label use of the stents in blood vessels rather than in bile ducts. The stents have been approved to prop open the bil ducts in patients whose ducts have become obstructed due to pancreatic cancer.
1.5 million Americans are injured or killed by prescription drug errors each year. Prescription errors in hospitals are so common that patients are subject to drug errors each day they are hospitalized. These are the conclusions drawn by the notable Institute of Health. These errors not only cause further injury and sometimes death, they cost billions of dollar to correct. The Institute noted that many of these mistakes could be avoided if doctors used electronic prescribing methods and hospitals utilized a standardized bar code system. According to the Institute, 25% of the errors are preventable.
Biogen’s multiple sclerosis drug Tysabri has been linked to liver injury. The link was strong enough that the FDA posted a warning on its website. Biogen sent warning letter to doctors advising them of the potential liver damage. Signs of liver injury can manifest themselves as early as 6 days from initially taking the drug. Tysabri has also been used to treat Chron’s disease.