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By Wagenitz, Andreas Mueller, Edgar A; Frentzel, Adrian; Cambon, Nathalie Key words: Analgesia - Diclofenac - Non-inferiority analysis - NSAID - Osteoarthritis - Sustained-release ABSTRACT Objective: To compare the analgesic efficacy and tolerability of a sustained-release pellet formulation of diclofenac (Olfen-100 SR Depocaps, SR-CAP, Mepha Ltd, Aesch, Switzerland) with the standard reference formulation (Voltaren retard 100, SR-TAB, Novartis Pharma AG, Basel, Switzerland), both containing...

How does a drug go from blockbuster to bust?How can big safety issues go undetected in medicines taken by millions of people for many years, as happened this week with the diabetes pill Avandia and a few years ago with the painkiller Vioxx?Or with devices like drug-coated stents, which came under a cloud last year after 6 million heart patients had already received them?All roads - and fingers this week - point to the U.S. Food and Drug Administration. From a company's labs to a consumer's...

By Saudan, M; Saudan, P; Perneger, T; Riand, N; Et al We examined whether a selective cyclo-oxygenase-2 (COX-2) inhibitor (celecoxib) was as effective as a non-selective inhibitor (ibuprofen) for the prevention of heterotopic ossification following total hip replacement. A total of 250 patients were randomised to receive celecoxib (200 mg b/d) or ibuprofen (400 mg t.d.s) for ten days after surgery. Anteroposterior radiographs of the pelvis were examined for heterotopic ossification three...

U.S. firm Merck said Monday its new COX 2 painkiller -- in the same class as Vioxx -- has a cardiac risk similar to Novartis' Voltaren. According to data from a large patient trial released Monday, Merck said its new arthritis treatment Arcoxia (etoricoxib), carries a comparable risk of heart attack and other cardiovascular events, compared to Voltaren (diclofenac), but showed a lower risk of gastrointestinal problems, like bleeding ulcers. However, Merck said the data also revealed that a...

NEW YORK (Reuters) - A federal judge overturned a $50 million award handed down by a jury against Merck & Co. Inc. earlier this month in a case of a former FBI agent who had blamed the withdrawn painkiller Vioxx for his heart attack. In a written ruling, U.S. District Court Judge Eldon Fallon did not dispute the jury's finding that Merck knowingly misrepresented or failed to disclose a material fact regarding Vioxx safety to the plaintiff's physician, but ordered a new trial to...

NEW YORK (Reuters) - A federal judge overturned a $50 million award handed down by jury against Merck & Co. earlier this month in a case of a former FBI agent who had blamed the withdrawn painkiller Vioxx for his heart attack, the Wall Street Journal reported on its web site on Wednesday. Merck did not immediately return phone calls seeking comment. A New Orleans jury in the federal trial had found that Merck knowingly misrepresented or failed to disclose a material fact regarding...

CHICAGO -- Merck & Co. on Wednesday said the experimental arthritis drug Arcoxia, in a study, met its main goal of causing no more blood clot-related heart attacks than a standard treatment, but more patients taking Arcoxia withdrew from the trial due to serious side effects.The trial pitted Arcoxia, the planned successor to Vioxx, against diclofenac, a widely used non-steroidal anti-inflammatory drug, among patients with osteoarthritis and rheumatoid arthritis.Vioxx was pulled off the...

CHICAGO (Reuters) - Drugmaker Merck & Co. on Wednesday gave preliminary results of a study of its investigational painkiller Arcoxia, the planned successor to Vioxx, which was pulled off the market in 2004 after being linked to stroke and heart attack.Merck said the study, comparing Arcoxia with the anti-inflammatory drug diclofenac, found the "relative risk" of certain cardiovascular events was similar.The incidence of patients withdrawing from the study due to side effects...

By Peter Henderson NEW ORLEANS (Reuters) - Merck & Co. on Thursday suffered a double setback when a federal jury awarded $51 million to a former user of its withdrawn pain medicine Vioxx, and a New Jersey judge threw out a Vioxx verdict that had favored the drug maker and ordered a new trial. The news sent its shares down 5.7 percent, and evened the score between Merck and plaintiffs in Vioxx cases at four victories apiece. The company is facing at least 14,200 other lawsuits from...

By Peter Henderson NEW ORLEANS (Reuters) - Merck & Co. on Thursday suffered a double setback when a federal jury awarded $51 million to a former user of its withdrawn pain medicine Vioxx, and a New Jersey judge threw out a Vioxx verdict that had favored the drug maker and ordered a new trial. The news sent the company's shares down more than 5 percent, and evened the score between Merck and plaintiffs at four victories a piece. The company is facing at least 14,200 other lawsuits from...