FDA sees potential link between proton-pump inhibitors and hip fractures, not heart problems
WASHINGTON When the Food and Drug Administration released a statement Monday declaring such drugs as Prilosec and Nexium had no negative effect on patients in regards to heart-related illnesses, it mentioned an unrelated potential problem, according to Reuters.
The statement stated that Prilosec and Nexium, while not having a link to heart problems, did pose a potential risk for hip fractures. According to the study on which the FDA is basing its review, the drugs, which are used to remedy severe reflux disease, inhibit the absorption of calcium in the body.
Last December, the Journal of the American Medical Association reported on a study suggesting that long-term use of the drugs, called proton pump inhibitors, increases the risk of hip fractures in adults over 50.
“Internally we’ve looked at the issue and we’ve asked the sponsors to send additional information and analysis,” said Joyce Korvick, deputy director in the gastroenterology unit at FDA, in response to a question during the press conference. “That is under review.”
Court overturns $3 million jury award against Wyeth’s Prempro
PHILADELPHIA A judge has overturned a jury’s decision to award a woman $3 million for claiming that Wyeth’s hormone-replacement drug Prempro caused her breast cancer, according to the Associated Press. The judge said the plaintiff did not have sufficient evidence to show that the company acted negligently.
Only four of about 1,500 cases pending in Philadelphia have gone to trial. Each time, a jury sided with the plaintiff only to have the judge reverse the verdict, lawyer Tobi Millrood said. The plaintiff, Jennie Nelson plans on appealing the decision to the state Superior Court.
Nelson had claimed that she was diagnosed in 2001 after taking the drug for five years to treat symptoms of menopause. Her lawyers argued that the manufacturer Wyeth had knowledge the drug caused cancer, yet failed to issue adequate warnings.
This is in contrast to a recent decision in Nevada that saw Wyeth lose a verdict to three women who made the same claims. The women won $134 million in that case.
Sun Pharma, Novartis reach agreement on Exelon
MUMBAI, India Sun Pharmaceuticals and Novartis have reached an out-of-court settlement in relation to Novartis’ Alzheimer’s drug Exelon, according to published reports.
“Under the terms of the settlement, Sun Pharma will not market generic Exelon in the U.S. until sometime prior to the expiration of the patents covering Exelon. The specific date on which Sun may launch and the other terms of the agreement are confidential,” said Sun Pharma in a statement.
Sun Pharma, being one of the first to file an application to sell generic Exelon in the U.S, was eligible to share a 180-day marketing exclusivity on the drug. However, had it launched its generic version of Exelon before reaching an agreement with Novartis, it would have done so at risk of damage claims by Novartis for patent infringement.
Exelon had sales of about $200 million last year in the U.S.