FDA & Prescription Drugs

• Pregnant Women on Anti-Depressants

  Robert Blanchard | April 24, 2006 4:41 PM | 0 CommentsPensacola, FL

  JAMA had an abstract this week of a study about the neonatal abstinence syndrome after in utero exposure to SSRIs. They found that this syndrome occurs in 30% of neonates exposed to these drugs in utero. They suggest that neonates be monitored for 48 hours after birth (at least), and they say that long term effects are not known.The babies can have a number of symptoms from this abrupt...

• Court Documents Show Ortho McNeil Knew Ortho Evra Was Lethal

  Joe Saunders | April 24, 2006 6:40 AM | 0 CommentsOrlando, FL

  Documents have surfaced in litigation that show Ortho-McNeil has been analyzing the FDA's death and injury reports on women using the Ortho Evra birth-control patch, and has charts that show a higher rate of blood clots and deaths in women on the patch when compared to women who take birth-control pills. In addition, according to a November 11, 2005, article by the Associated Press, an internal...

• GAO Criticizes FDA on How it Handles Drugs

  Joe Saunders | April 24, 2006 6:35 AM | 0 CommentsOrlando, FL

  The Government Accountability Office has published a report sharply critical of the Food and Drug Administration. The report states that the organization is sometimes too slow in recognizing safety problems once drugs have gone to market. The GAO report also says the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from...

• Benzene in Soft Drinks

  Staff Writer | April 22, 2006 8:31 PM | 0 CommentsDenver, CO

  It has been reported that the FDA has not been very forthcoming about the issue of Benzene in soda. Benzene is a carcinogen that has been linked to cancer such as leukemia. The current means of evaluating the effects of benzene is in terms of life-time exposure but it is unclear what precise amounts of Benzene and what type of exposure will cause health complications. Many experts do not feel...

• Fungal Keratitis

  Staff Writer | April 20, 2006 4:35 PM | 0 CommentsDenver, CO

  There has been a recent increase in eye infections in soft contact lens wearers using Bausch & Lomb's ReNu with MoistureLoc brand contact lens solution or a generic brand manufactured by them. These rare but serious eye infections are being caused by the fungus Fusarium and can result in permanent loss of vision requiring corneal transplant. In early April the U.S. Food and Drug Administration...

• So what is an MDL?

  Staff Writer | April 19, 2006 9:31 AM | 2 CommentsDenver, CO

  Many folks have recently seen or perhaps heard of the Vioxx, Celebrex, Bextra, Ortho Evra, Guidant and Medtronic "MDLs" in the media. So what is an "MDL"? Well, its shorthand for multidistrict litigation. The first thing you need to know about multidistrict litigation is that its not the same thing as a class action. A class action is a lawsuit where a few people sue on behalf of themselves and...

• Accutane, Pregnancy & Birth Defects

  Bob Carroll | April 19, 2006 4:36 AM | 0 CommentsPinellas, FL

  Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government. She has just posted a well-researched article on Accutane and its trail of misery, particularly for pregnant women. According to the March of Dimes Foundation, birth defects known to be associated with Accutane include: hydrocephaly (enlargement of the...

• FDA ASKED MERCK TO WARN OF FOSAMAX RISK IN 2004

  Robert Blanchard | April 18, 2006 10:19 PM | 0 CommentsPensacola, FL

  A lot of doctors were surprised to learn that the FDA had asked Merck of the risk of osteonecrosis of the jaw and Fosamax back in August 2004 - - right at the same time Merck was forced by circumstances to pull Vioxx from the shelves. Merck has yet to put any information in its WARNINGS about the risk of osteonecrosis of the jaw and Fosamax.After my partner Tim O'Brien's article appeared in the...

• Ortho Evra Settlements

  Robert Blanchard | April 18, 2006 9:39 PM | 0 CommentsPensacola, FL

  Despite recent reports of settlements in the Ortho Evra litigation, most lawyers a simply moving forward with getting their cases to trial. No blanket offers have been made and no expects the litigation to be resolved soon, except for isolated cases that Ortho McNeil iis afraid to take to trial. I am hoping that something can be done for the women who have suffered and the families that are...

• Mirapex caused gambling

  Staff Writer | April 18, 2006 9:27 PM | 0 CommentsDenver, CO

  A retired doctor from Austin has sued Las Vegas casinos and the maker of Parkinson drug Requip, claiming that they caused compulsive gambling behavior that ultimately cost him $14 million in Las Vegas. The plaintiff cites a 2005 Mayo Clinic study documenting 11 Parkinson's patients who developed compulsive behaviors while taking Requip or Mirapex.See the American-Statesman article by clicking...