FDA Warns Against Using Over the Counter Novartis Drugs
It has been recently said by the US Food and Drug Administration (FDA) authorities that drugs like Percocet, which are addictive in nature, may now be included in the new drug mix up plan by Novartis. They are of the warning that this might be the potential reason for a terrible drug mix up. In […]
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Federal regulators warn Johnson & Johnson’s insulin pump business to correct violations
Federal drug regulators have chastised Johnson & Johnson’s subsidiary, Animas, for selling faulty insulin pumps and failing to report injuries suffered by patients using its devices. In a warning letter to Animas managment, regulators with the Food and Drug Administration described numerous instances when the company failed to comply with regulations requiring it to report […]
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FDA probing J&J delays in reporting serious injuries among users of its Animas insulin pump
The widening quality problems at health giant Johnson & Johnson have former regulators and analysts mystified, as yet another J&J business — at least the seventh — has come under scrutiny. The lapses are hard to reconcile with J&J’s image: It’s the company that decades ago set the textbook standard for protecting public safety with […]
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FDA warns of pain pill mix-ups
The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications made at a Novartis manufacturing plant. The issue stems from manufacturing problems at a Lincoln, Neb., facility which triggered a recall Sunday of 1,645 lots of Novartis’ over-the-counter drugs, including Excedrin, Bufferin, NoDoz and […]
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Myth Versus Reality: Promoting A Pricey Gout Pill
Nearly three years ago, the FDA approved a version of colchicine – a cheap, decades-old treatment for gout – and a controversy quickly ensued. The new med won approval under the Orphan Drug Act, which means the manufacturer received seven years of marketing exclusivity. And the FDA later forced other manufacturers to halt marketing on […]
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Americans Cut Back on Health Care During Recession
In 2009 and 2010 total health care spending grew at just under 4 percent, at the slowest rate since the government began keeping records over fifty years ago, one big reason is that Americans dramatically curtailed their use of physician and hospital services. “This certainly was a very deep and significant recession,†said Stephen Heffler, […]
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Nicotine patches, gums won’t help smokers quit long-term
Nicotine patches and nicotine gum — the popular mainstays of so-called “nicotine replacement therapy” — don’t help many smokers kick the habit and remain cigarette-free over the long haul, new research suggests. The study authors concluded that the findings raise “serious questions” about the effectiveness of nicotine replacement therapy as experienced by most smokers. This […]
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Boehringer’s Pradaxa Increases Risk of Heart Attack, Study Shows
Boehringer Ingelheim GmbH’s anti- coagulant Pradaxa increases a patient’s risk of heart attack or severe chest pain, according to a review of studies conducted on the drug. An analysis of seven clinical trials found that it was “significantly associated with a higher risk†of heart attacks and acute coronary syndrome, or ACS, a designation that […]
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CROs Blast New Clinical Trial Rules In India
Overseas clinical trials are a perennially controversial issue, but especially in India, where the population is regularly tapped by overseas drugmakers. At the same time, the Indian government is increasingly concerned about patients. Notably, India’s health ministry last year found that drugmakers running clinical trials had not compensated survivors of most volunteers who died during […]
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Senator warns FDA on danger of newest super painkillers now under review after NY shooting
Following fatal shootings in two New York pharmacy robberies, a U.S. senator is warning that a new batch of “super painkillers†now under review could force repeats of recent violent robberies that left six people dead. “It’s tremendously concerning that at the same time policymakers and law enforcement professionals are waging a war on the […]
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