First Live Liver Transplant In Scotland Is Successful
March 2, 2008
The live liver transplant from Jennifer Foster, who donated over 50% of her organ to her husband Daniel, was deemed a success by the Royal Infirmary of Edinburgh Transplant Unit.
It was the first time the procedure had been done in Scotland.
Because the liver can regenerate at a rapid rate, both the donor and the recipient are expected to experience substantial regrowth of the partial organ.
“I’m elated that this operation has been a success,” Mrs. Foster was quoted by the BBC as saying.
“This type of operation will open up a new avenue for some liver transplant patients who have a willing, suitable donor.”
Naturally, Mr. Foster is elated as well.
“I can’t wait to start living the years ahead with my amazing wife,” the appreciative husband declared.
Baxter Issues Heparin Recall
March 2, 2008
Baxter International Inc. has issued a voluntary recall for all of its heparin sodium injection products, including single-dose, multidose, and and HEP-LOCK heparin flush products.
The drug, currently under investigation by the Unites States Food and Drug Administration, has been linked to at least four deaths and scores of adverse reactions.
At the Chinese factory where an ingredient for the drug is supplied, U.S. regulators reported “objectionable conditions”. But a definitive connection to the Chinese plant and the heparin issues has not been made by the FDA to date.
“It’s like trying to put together pieces of a puzzle,” said Sandra Kweder, deputy director of the agency’s Office of New Drugs. “So far, an underlying cause of the adverse events is not known and it remains under investigation.”
“We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs,” said Peter J. Arduini, president of Baxter’s Medication Delivery business. “The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue.”
More details about the recall, including what you should do if you already have the recalled product, can be found at the FDA website.
FDA Gives OK To Wyeth’s Pristiq
March 2, 2008
The U.S. Food And Drug Administration has approved Wyeth’s new antidepressant Pristiq.
Pristiq is the successor to Effexor, which accounted for about seventeen percent of Wyeth’s total revenue with sales of $3.8 billion.
Since generics are expected to chip into that profit margin, a new antidepressant with the benefit of patent protection will certainly help the company’s bottom line.
It’s not the end of the line for FDA evaluation, however. Approval was conditional on the drugmaker agreeing to multiple post-marketing commitments, which will include submission of data from multiple studies.
“PRISTIQ is an important new therapeutic option for patients and clinicians because no single therapy works for all people with major depression,” said Philip Ninan, M.D., Vice President of Wyeth Medical Affairs, Neuroscience.
“PRISTIQ is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose. We are encouraged by the tolerability profile seen in clinical studies.”