Warnings added to flu medicine labels
LONDON and ZURICH, Switzerland Roche Holding and GlaxoSmithKline have added new labels to their prescription flu medicines to warn of reports of abnormal psychiatric behavior in some patients, according to Reuters.
Roche’s drug, Tamiflu, had already added these warnings to its label, but added to it that some of the cases of abnormal behavior were fatal. GSK added a warning that stated delirium and abnormal behavior could result with use of its drug Relenza. Both companies though note that the contribution of their drugs to these events has not been established.
The companies said the revisions reflected recommendations made in November 2007 by an FDA advisory panel that reviewed cases of the abnormal psychiatric behavior, which have been seen mostly in Japan. At that meeting, FDA staff described reports of about 700 cases of psychiatric adverse events for both drugs and 25 pediatric deaths from various causes in patients taking Tamiflu, reported to the agency through May 2007. No fatalities were reported for Relenza.
The labels also recommend that physicians should closely monitor patients on these drugs.
Von Eschenbach, Leavitt visit Dr. Reddy’s facility in India
HYDERABAD, India In January 2008 Food and Drug Administration Commissioner Andrew von Eschenbach and Secretary of Health and Human Services Michael Leavitt visited a Dr. Reddy’s facility near the pharmaceutical manufacturer’s headquarters here.
Leavitt was focused on assuring the quality of the products as well as creating collaborations beyond borders while von Eschenbach, also concerned with the safety and quality of products, focused on the transparency of the manufacturing process.
Dr. Reddy’s was the only facility in India the two visited as part of a multi-national effort to ensure the safety of the pharmaceutical supply chain.
Congressional report estimates CMS changes would cost states $50 billion in federal aid
WASHINGTON According to a congressional report prepared by the Democratic staff on the House Committee on Oversight and Government Reform, proposed changes to Medicaid would cost states about $50 billion in federal aid over the next five years, the Associated Press reported.
“As the economy tips into recession, the last thing we should be doing is taking federal funds from states, especially funds that are supposed to help people with their health and medical expenses,” said committee chairman, Rep. Henry Waxman, D-Calif.
Federal officials, though, are arguing that the changes are designed to ensure that providers don’t bill the program for more than costs of providing care and also say that the states pay their fare share of the program.
Tthe proposed new rules include limiting Medicaid public hostpital reimbursement to no more than the cost of providing a particular service. Another would prohibit billing Medicaid for the costs of medical interns and residents.
Overall, the federal government will spend more than $1.2 trillion on Medicaid over the next five years. The administration projects that if all the changes it seeks were enacted, the federal government would save about $13 billion over those five years.