Thyroid disease drug approved in 1947 could cause serious liver injury, FDA says
ROCKVILLE, Md. An anti-thyroid drug used to treat Graves’ disease could increase the risk of serious liver injury, the Food and Drug Administration said Wednesday.
The agency said 32 cases of serious liver injury associated with the use of propylthiouracil, also known as PTU and approved in 1947, were reported through its Adverse Event Reporting System between 1969 and October 2008. The 22 adult cases included 12 deaths and five liver transplants, while the 10 cases in children included one death and six liver transplants.
“After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves’ disease, methimazole,” FDA official Amy Egan said in a statement. “Healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease.”
Graves’ disease is an autoimmune disorder that leads to overactivity in the thyroid gland.
Par ships first generic version of J&J drug
WOODCLIFF LAKE, N.J. Par Pharmaceutical Cos. has begun shipping its generic version of a drug used to treat schizophrenia and bipolar disorder.
The company announced Tuesday the shipment of risperidone ODT in the 0.25-mg, 3-mg and 4-mg strengths. The drug is used in adults as a stand-alone treatment for schizophrenia and as a combination, with lithium or valproate, for the treatment of manic and mixed episodes in bipolar I disorder.
The drug is a generic version of Johnson & Johnson’s Risperdal M-TAB, which had sales of $89 million last year, according to IMS Health data. As the first company to file an approval application with a paragraph IV certification, Par has six months of market exclusivity, though J&J retains exclusivity for the use of the drug in children.
FDA creates transparency taskforce
ROCKVILLE, Md. After years of criticism, the Food and Drug Administration wants to take the tinting off its windows.
The agency announced Tuesday the creation of an internal transparency taskforce, headed by principal deputy commissioner Joshua Sharfstein, to find ways to make its decision making more transparent for the public while protecting confidentiality.
“Over the years, there have been complaints made about the FDA’s lack of transparency,” commissioner Margaret Hamburg said in a conference call with reporters Tuesday morning.
Hamburg said the taskforce would take comments from the public and stakeholders to find ways to make information about agency operations, recall information, enforcement and other activities more accessible. The agency will convene a public meeting on June 24 and another one in the fall and accept public comment through a docket until Aug. 7.
“The recommendations of the taskforce will allow us to more effectively implement the agency’s public health mission,” Hamburg said.