The FDA has recently completed a comprehensive review of the safety data for both Prilosec and Nexium. Recently, there have been concerns voiced in the media about the safety of these drugs. Often times, the media is quick to jump on a report that may suggest an issue with a pharmaceutical product, the reality of the situation is often much more complex and needs to be thoroughly reviewed before any assumptions are made or published.

On Wednesday, Merck & Co, voluntarily recalled 1.2 million units of their children’s vaccine for Haemophilus influenzae type b (Hib). The vaccine is used to protect children, under the age of 5, from bacterial meningitis.

The 11 lots of PedvaxHIB vaccine and two lots of its Comvax vaccine were reportedly recalled due to concerns over the sterility of the product. All but one of the 13 lots recalled were distributed in the US. Merck has said that the possibility for contamination for any individual vaccine is low and that all of the sterility testing performed on the recalled lots has not shown any contamination. All of the products involved in the recall were manufactured in West Point, Pennsylvania, and distributed starting in April 2007.

FDA advisers recently suggested that the world's most widely used flu drug should carry stronger warnings. The current warning label references the fact that there have been reported cases of delirium and self-injury. The panel of advisers suggested that the FDA require the manufacturer, Roche, to include language about recent deaths in Japan based on abnormal behaviors. Five deaths have been reported in Japan after children had been prescribed Tamiflu, the children falling out of windows or running into traffic caused the deaths.

According to a speech given recently by AstraZeneca PLC's Chief Executive Tom
McKillop, he feels the pharmaceutical companies that currently conduct major portions of their R&D in the US may shift a large portion of that work to China and India if the government approves drug importation. McKillop answered many questions on importation during a question and answer period. He warned that the US would catch the “European disease” of the 1990’s in which Europe lost it’s dominance in the R&D area of pharmaceuticals due in part to a number of unfavorable new policies, including parallel trading between countries.

Bextra, the COX-2 inhibitor painkiller, manufactured by Pfizer was pulled from the market last Thursday due to FDA concerns over increased risk of heart attack and stroke, along with a rare but possibly life threatening skin condition. The FDA and it's European counterpart requested that Pfizer stop all sales in US and Europe. The FDA also ordered that 19 other popular prescription competitors, from Celebrex to high-dose naproxen are to be labeled with tough new warnings of elevated risk of heart attack and stoke.