Merck wins Florida liability suit
WHITEHOUSE STATION, N.J. A Florida Circuit Court found a liability case against pharmaceutical company Merck was implausible, the company announced Friday.
The product liability suit claimed that Merck, developer of the medication Vioxx, had caused the plaintiff, Refik Kozic, to suffer a heart attack. The medication, designed to treat osteoarthritis symptoms and pain, was withdrawn from the market three years ago after data from a company study reflected some unwanted results.
The evidence showed that the Kozic had significant atherosclerosis and coronary artery disease in the vessels that supply blood to the heart, including the vessel where the heart attack actually occurred. Kozic had high cholesterol and other risk factors that contributed to the progression of his disease over a long period of time.
“We believe the evidence showed that Merck acted responsibly and that Vioxx was not the cause of Mr. Kozic’s heart attack,” said Merck’s outside counsel Mike Brock. ”We believe that Mr. Kozic’s longstanding cardiovascular disease caused his heart attack.”
Florida Circuit Court Judge William P. Levens presided over the case. This was the first Vioxx case in Florida to go to trial.
FDA increases potency of levothyroxine products
WASHINGTON The Food and Drug Administration is strengthening the potency specifications for levothyroxine sodium to ensure the drug retains its potency over its entire shelf life.
The agency is increasing the specifications from a 90 to 110 percent potency range to a 95 to 105 percent range. The percent ranges were changed following concerns about the product by healthcare professionals and patients.
Data taken by the FDA showed that some of the levothyroxine products like blister packs degrade quicker than other package types. Also, some of the strengths have been shown to degrade more rapidly than others.
Manufacturers and marketers have two years to comply with the revised specification. Levothyroxine sodium products are used by over 13 million patients.
FDA to review heart problems from osteoporosis drugs
WASHINGTON The Food and Drug Administration is looking at new safety data on reports of atrial fibrillation in patients taking bisphosphonates.
Bisphosphonates are used to treat osteoporosis. The FDA is looking into the issue after a study in the May 3rd issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in patients taking Fosamax and Reclast.
The FDA has performed an initial review and found that there was not a large enough group of people who were at risk for atrial fibrillation and would not as of right now ask for healthcare professionals to change their prescribing habits or to tell patients to change their use of the drugs.
The agency is seeking additional data to perform an in-depth review of the issue that could take up to one year to conclude.