The media has been full of reports of lawsuits filed against Bayer recently, all related to the company’s oral contraceptives Yaz and Yasmin.
This week alone six lawsuits were filed in Toledo. The allegations in these suits focus on misrepresentation of the adverse effects associated with the pill. Those adverse effects would include stroke, embolism and other life-threatening events. According to the suits, Bayer did not advertise proper warnings and did not adequately disclose the potential risks. One of the suits was brought by the family of a 25-year old mother who died from a stroke in 2006, allegedly while taking Yaz.
Between the first quarter of 2004 and the third quarter of 2008 reports indicate that more than 50 Yasmin- or Yaz-related incidences of death were filed with the FDA, one involved a 17-year old woman. The causes of death allegedly involved pulmonary embolisms, stroke and cardiac arrests. Read the rest of this entry »
In March of this year, the FDA announced that it would be investigating the anti-epileptic drugs phenytoin and fosphenytoin in connection with their potential to cause Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). (fyi, Phenytoin is marketed as Dilantin, Phenytek and generics. Fosphenytoin sodium is marketed as Cerebyx and generics.)
One of the factors that may have played into the FDA investigation is a reported higher incidence of SJS in Asian patients taking these drugs, specifically Asians who test positive for the human leukocyte antigen allele HLA-B*1502.
While the FDA reports that as much as 15 percent of the population in China, Taiwan, Thailand, Malaysia, Indonesia and the Philippines may have this allele, they don’t believe there’s enough information to warrant testing for the allele in the US for patients of Asian ancestry—yet. Read the rest of this entry »
Here’s something scary. Type this into Google search: How much Tylenol do I give?—just for the heck of it. I just did. I figured with all the news lately on acetaminophen and the FDA Advisory Panel recommending more stringent warnings on OTC acetaminophen, there must be some worthy sites getting the word out on safe dosing, right?
Here are the 9 links listed on the first page of my search results:
pediatrics.about.com (they have a dosing “calculator”, then tell you to check the answer with your doctor)
plateaupediatrics.com (a local pediatrician’s office in TN)
wiki.answers.com (yes, those pages where anyone can contribute info)
abcnews.go.com (ok, it has a video of a doctor answering the question)
thelaboroflove.com (a having babies site—and I’m having to work too hard for an “about us” page)
fda.gov (it doesn’t give the answer to my question, but at least it’s from the FDA)
answers.yahoo.com (to date, the “best answer” by voters is from a user named “Courage”; No, I’m not kidding.) Read the rest of this entry »
The Wall Street Journal (WSJ) ran an interesting story recently on the type 2 diabetes medication, Avandia, and the latest study evaluating its safety.
Also known as rosiglitazone, Avandia has come under scrutiny as a result of a study published in 2007 by Dr. Steven Nissen, which found an increased the risk for heart attack in patients taking the drug. In the recent WSJ article, Nissen commented on the new RECORD trial, saying that it is “seriously flawed.”
Researchers being researchers, they will likely argue the results till the cows come home, which really isn’t very helpful if you’re taking Avandia and looking for some definitive answers.
One thing’s for certain, though, the lawyers aren’t waiting for the holy grail of scientific consensus. In fact, they’re trying to make people aware that the statute of limitations may be coming up in some states for people who are considering a lawsuit against the makers of Avandia, GlaxoSmithKline.
In a recent interview with a LAS, Jeff Lowe, with The Lowe Law Firm, said that the statute of limitations varies depending on where you live, so if you’ve suffered an adverse event while taking Avandia you’d better contact a lawyer sooner rather than later.
Just in case you’re wondering, as I was, what a statute of limitations is—a short definition is: a statute within a legal system that sets a maximum period of time in which legal proceedings based on events within that time period can be instigated. In other words, cases have expiration dates.
Better ask a lawyer…
A number of years ago, these three—Reglan, Tardive Dyskinesia and Marijuana—probably would not have been sitting in a headline together. But with the recent FDA-imposed black box warning for Reglan—the one that states the drug can bring on potentially chronic and debilitating neurological side effects (translation: tardive dyskinesia), Reglan’s been sitting side-by-side more often in text than GERD or “acid-reflux” patients would like.
The disturbing thing about Tardive Dyskinesia—aside from the fact that it’s a potential side effect of something used to treat a condition that’s seemingly rather commonplace—is that any resource you go to will tell you there is no treatment for it. That’s right: no treatment. And it can be completely debilitating—there are no shortage of videos on youtube.com to give you an impression of how challenging the condition must be to live with. Read the rest of this entry »