Tygacil treats infections caused by bacteria. The FDA Drug Safety Communication has issued a warning of increased risk of death with IV antibacterial Tygacil (tigecycline) and is now requiring a boxed warning (highest warning) of increased death with Tygacil as compared to other drugs in the category. Tygacil should now only be used when all other choices have been exhausted.

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The latest question before the FDA concerns the use of ARBs (angiotensin receptor blockers), when used primarily to manage hypertension. Dr. Thomas Marciniak, FDA official, says the use of ARB-drugs seem to be linked somehow to an increase in the risk of lung cancer. Other FDA officials disagree and don’t want to promote/demand any further clinical or epidemiological studies. What makes this issue interesting? Marciniak works for the FDA and has brought his concerns to the public, whose internal discussions are usually kept tight to the vest within the Agency. Literally millions of hypertensive patients are currently take ARBs. Sales of ARBs were $7.6 billion in the US last year. The FDA seems…

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Addressing rising concerns of “superbugs,” plans have been proposed to push new antibiotics through the FDA process on a fast track. These new drugs would be designed specifically to fight infections resistant to exiting antibiotics — skipping tests usually required until after the drugs are already being used. The New York Times reports that Dr. John H. Powers, a former F.D.A. antibiotics reviewer, worries that drug companies might have little incentive to broadly test such an antibiotic once it’s been approved for use on a small group. Unless safeguards are put in place, it might eventually be used in millions of people…

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