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FDA to List Drugs Being Investigated

The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.

The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said yesterday.

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WNCT FDA Demands Tougher Warnings on Immunosuppressive Drugs

Federal health authorities have asked the manufacturers of four widely used immunosuppressive drugs to bolster safety warnings on the risk of developing opportunistic fungal infections.

The drugs, Humira, Cimzia, Enbrel and Remicade, belong to a class of medications known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system and are approved to treat several conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn's disease.

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FDA staff note deaths in Pfizer bone drug study

A higher percentage of patients treated with an experimental Pfizer Inc drug for osteoporosis died during a clinical trial compared with a placebo, U.S. drug reviewers said in an analysis released on Thursday.

The higher proportion of deaths through five years was statistically significant only for the lowest dose of the drug called Fablyn, said Food and Drug Administration reviewers. More patients given Fablyn, which was co-developed with Ligand Pharmaceuticals Inc, also developed blood clots.

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Vytorin Linked to Cancer; Prominent Medical Journal Reverses Stance

In an unprecedented change of posture, the New England Journal of Medicine has reversed itself on the issue of whether Vytorin causes cancer.

Vytorin is the controversial cholesterol lowering drug that is the center of a major advertising fraud that netted Merck and Schering-Plough over 10 billion dollars in sales in the past two years. Merck and Schering-Plough are facing congressional investigation, various state attorney general investigations, and plaintiff class action lawsuits. All the negative publicity has caused sales to fall off, yet the questionable drug is still a top seller for Merck and Schering-Plough in 2008.

Underneath the advertising fraud is a far more damaging prospect from the Big Pharma point of view, that the theory of lowering LDL cholesterol with drugs to prevent heart disease is itself a major fraud that has been perpetrated on the American public for the past decade. Indeed, while Vytorin is the most effective drug combination of all time in terms of lowering LDL, doing so does not produce cardiovascular health or reduce cardiovascular mortality.

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Study: New way to spot breast cancer shows promise

A radioactive tracer that "lights up" cancer hiding inside dense breasts showed promise in its first big test against mammograms, revealing more tumors and giving fewer false alarms, doctors reported Wednesday.

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Best-Selling Cholesterol Drugs Found Ineffective

Three million people worldwide are taking the new, heavily advertised anti-cholesterol drugs Zetia and Vytorin, despite a lack of clinical evidence that they reduce cardiovascular disease or heart attacks, or help patients live longer. Vytorin and Zetia brought in $5.2 billion last year for Merck and Schering-Plough, placing them among the best-selling drugs in the world. The Food and Drug Administration approves many drugs based on whether they perform a specific action, like lowering cholesterol, without requiring long-term trials on whether they extend life or lower disease risks. Other FDA-approved drugs have been found to be ineffective or even dangerous.

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Concerns Linger Over Safety Of Chemical Used in Baby Bottles

Government experts on Wednesday released a final report on the safety of a chemical used in plastic baby bottles, saying they have "some concern" the chemical is linked to health and developmental problems.

The chemical, bisphenol-A, or BPA, makes plastic hard and shatterproof, and is used in hundreds of consumer products from plastic baby bottles to CDs.

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