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2nd July 2009 HCFI: 2009:  FDA To Require Boxed Warnings on Serious Mental Health Risks for Champix & Zyban : The FDA announced today that it will require manufacturers to place boxed warnings on the labels of varenicline (Champix bupropion (Zyban) regarding the risk of serious mental health events, including changes in behavior, depressed mood, hostility, and suicidal thoughts.

FDA Advisors Recommend "Black Box" Warning for All Prescription Products Containing Acetaminophen or Paracetamol: Members of an FDA advisory panel have overwhelmingly recommended that the FDA add a black box warning to the labels of prescription pain and cold products that contain acetaminophen. About 42,000 people visit emergency departments each year in the US with paracetamol overdoses, half of which are accidental. They often occur when a consumer unknowingly takes more than one paracetamol product.  One advisory panelist attributed 10% of fatalities from paracetamol overdoses to combination products.
 WHO says Tamiflu-resistant H1N1 "isolated case": The first H1N1 infection found to be resistant to the antiviral drug Tamiflu represents an isolated case with no current implications for public health. This is an isolated case. At this time, there is no public health implication. But we must remain alert as the virus can change at any time and we must not be complacent. Resistance to Tamiflu has been previously documented in the deadly bird flu virus H5N1 and seasonal H1N1 flu.

 Wider use of statins: An analysis of studies supports a growing belief that guidelines for prescribing cholesterol-lowering statin drugs should be expanded to include healthy people without established heart disease. The meta-analysis of 10 trials involving more than 70,000 participants found that statin therapy reduced overall mortality by 12 percent, major coronary events by 30 percent and strokes by 19 percent. It supports the findings of the JUPITER trial, reported last year, which noted 54 percent fewer heart attacks and 48 percent fewer strokes among people taking a statin who had normal cholesterol levels but high levels of C-reactive protein, a marker of inflammation. The analysis shows that "the more risk factors you have, the more aggressive you should be, and the lower the cholesterol level you should consider using statins for.
 Do not panic about Lantus:  Diabetivs have started panicking after new studies of 300,000 patients released on Friday suggested the Sanofi-Aventis insulin drug Lantus might raise the risk of cancer. Diabetes experts are cautioning patients to keep taking Lantus (The drug, known generically as glargine insulin). Four studies released in the journal Diabetologia raised concerns about the drug, but the results were conflicting. Lantus is typically taken just once a day. It has been widely used since 2000. It is not clear weather same problems would be seen in Levemir, another long-acting insulin analog made by Denmark's Novo Nordisk. The American Diabetes Association has recommended that patients continue on the treatment, and consult their doctor before making any changes. Insulin is a type of compound called a growth factor and prior studies have shown that when insulin is added to cells in a cell culture, it makes them grow. That would also include tumor cells. It may be that patients taking Lantus are simply exposed to insulin longer, and if they have any underlying tumors, the drug may accelerate tumor growth.