Earlier this year, the HPV vaccine was all over the news here in Austin and around the state as Governor Rick Perry attempted to unilaterally mandate that all school age girls receive the vaccine. Fortunately, after the legislature passed a law overturning the executive order, the Governor backed away from his plan.Now, stories are coming out showing why it's good to allow parents to make their...
In a move to make the relationship between the FDA and the outside advisors more transparent, the FDA will require them to disclose potential financial conflicts of interest in writing. In 2006, a study found that a quarter of all experts the FDA relied on for advice on drugs, including whether or not to approve them for public use, had a financial conflict of interest. The proposed changes...
Just days after the FDA hit the diabetes drug Avandia with new safety warnings the pharmaceutical company GlaxoSmithKline PLC, makers of Avandia, decided to take out full-page ads to run in 60 newspapers and in several magazines. The main messages is as follows: "If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or...
The FDA recently announced that GlaxoSmithKline, the manufacturer of Avandia, will be changing its boxed warnings to include the risk of heart attacks. Avandia is a drug used to treat type 2 diabetes. Studies have shown that people with type 2 diabetes who have an underlying heart disease or are at an increased risk of heart attacks while using this medication. For more information view the...
Last week, Merck & Co. agreed to a $4.85 Billion settlement with thousands of plaintiffs. Over the past few years, plaintiffs who were suffered significant injuries caused by Merck's powerful painkiller Vioxx. This settlement is to compensate those victims and put an end to another round of trials by other plaintiffs. Not surprisingly, as part of the settlement agreement Merck did not admit...
Today, the U.S. Food and Drug Administration announced - GlaxoSmithKline (GSK), manufacturer of the popular type 2 diabetes drug, Avandia, has agreed to add new warning information to the existing boxed warning about the potential risk for heart attacks.People who suffer from type 2 diabetes that have heart disease or who are at high risk of heart attack should talk with their medical doctor...
All over the United States consumers have sued for heart attacks and other serious injuries sustaned from using the drug Vioxx. This drug, heavily advertised as safe and effective, has been implicated in thousands of cases includiing allegations that it has caused widespread cases of death and permanent injury. The manufacturer of the drug vowed to fight all of the lawsuits in court. After...
The vaccine Gardasil was introduced last year as a way to combat cervical cancer in women. It works by preventing an infection with Human Papilloma Virus (HPV). Now there are reports of girls having adverse affects after receiving the vaccine. One such report is from the family of a 12-year-old girl in Florida that had paralysis in one leg two weeks after receiving the first injection. The...
The FDA announced today that the diabetes drug Avandia will now carry a black box warning label on the packaging. The black box warning label will state that the risk of heart attack may increase from taking the drug. The FDA notes that the greater risk of a heart attack has not been confirmed by three other studies done on Avandia. Despite this addition to Avandia's black box -- the FDA's...
On Wednesday, November 13, 2007, the U.S. Food and Drug Administration made public that they will require the diabetes drug Avandia to carry a "black box" warning saying that the drug could cause chest pain or heart attacks. The company will begin trial comparing Avandia to other rival drugs and placebo to see if the risk is unique to Avandia.FDA's Dr. Janet Woodcock told reporters that they...
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