LawyersandSettlements.com recently shared its list of the hottest consumer-related pharmaceutical legal news stories during the last year. Of note is that while the top drug-related topic on the legal news website in 2011 had been Tylenol—prompted by concerns over a series of Tylenol recall notices as reported by The New York Times; for 2012, the most sought out pharmaceutical topics have shifted to women’s health.
Third-generation contraceptives such as Yasmin/Yaz, NuvaRing and Mirena top the list this year as numerous birth control lawsuits either settled, or began the process of consolidation into multi-district litigation (MDL).
Reader interest in Yaz/Yasmin rose in response to Yasmin lawsuit settlements that were announced in April (In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois, East St. Louis). Bloomberg reported Bayer AG settled about 500 Yasmin lawsuits over claims of blood clots that had, in some cases, led to stroke or heart attack.
Along with Yaz, readers remained concerned about NuvaRing (etonogestrel/ethinyl estradiol) and blood clot risk even as a new study on non-oral hormonal contraception, published in the British Medical Journal (BMJ 2012;344:e2990), was presented at the annual meeting of the American College of Obstetricians and Gynecologists (May, 2012). The study, aimed at quantifying NuvaRing blood clot risk, indicated no significant difference in risk of venous thromboembolism when compared to oral contraceptives.
Still, NuvaRing lawsuits continue and have been consolidated into a federal MDL court in Missouri (In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri). As of September 5, 2012, according to the U.S. Panel on Multidistrict Litigation, more than 1,000 NuvaRing lawsuits have been filed.
Mirena IUD (levonorgestrel) saw an increase in reader interest after August 2012, as Bayer Healthcare Pharmaceuticals, Inc. submitted an Application for Centralized Management of Certain Cases involving Mirena. As FoxNews reported (11/11/12), the request seeks to create a multi-district litigation (MDL) for 16 pending Mirena lawsuits in NJ that allege Mirena caused uterine perforation, infection and hemorrhaging injuries.
After the top three women’s health-related drugs, Pradaxa (dabigatran), an alternative to warfarin, joined the list this year making the Top 5. In November 2012, the FDA issued a Drug Safety Communication regarding Pradaxa bleeding events which in turn helped drive reader interest.
Thousands of LawyersandSettlements.com monthly readers have followed the latest legal news and information on these topics, many of which have fallen from the radar of traditional media outlets.
“We believe these issues are of great importance to the public, mostly due to the life-changing impact they can have on an individual,” said Stephen King, CEO. “Some of our most interesting stories of the year related to pharmaceuticals. Many of them have pending lawsuits or have had substantial settlements related to their life-altering side effects and it’s important to get this information out to the public. While many pharmaceutical companies continue to earn significant profits, people are suffering. They may think they have no recourse but in many cases they do. By keeping these topics alive, LawyersandSettlements.com is helping people stay up-to-date on these important topics every day.”
The LawyersandSettlements.com Top 10 Pharmaceutical Topics of 2012, along with the potential side effects readers were seeking information on, are:
1. Yasmin/YAZ (gall bladder disease, blood clots, deep vein thrombosis, pulmonary embolism)
2. NuvaRing & Mirena (blood clots, infection, perforation of the uterus)
3. Pradaxa (uncontrollable bleeding, lack of an available antidote)
4. Granuflo (elevated bicarbonate levels, risk for metabolic alkalosis)
5. SSRIs (birth defects including heart defects, spina bifida, cleft palate, club foot, PPHN)
6. Actos (bladder cancer, heart failure, kidney failure, rhabdomyolysis)
7. Diethylstilbestrol/DES (cancer)
8. Crestor / Statins (diabetes, cardiomyopathy, rhabdomyolysis)
9. Fosamax (bone fractures, esophageal cancer)
10. Propecia (sexual dysfunction, erectile dysfunction, sterility, prostate cancer)
LawyersandSettlements.com readers are looking for the latest and most comprehensive legal news available. Those seeking legal help can request assistance by completing a form which is then distributed to attorneys specializing in these cases. Over two and a half million people visit the site yearly, and hundreds of thousands of request forms have been submitted by qualified readers looking for legal guidance.
In recognition of American Heart Month, which kicks off tomorrow (Feb. 1st), and National Wear Red Day (Feb. 3rd), LawyersandSettlements.com takes a look at our most-viewed drug lawsuit topics for 2011 in which heart attack or heart side effects were the alleged primary injuries.
Unfortunately, while a lot of focus this month will be on the positive measures we all can take to improve heart health—and that’s certainly important—it can be easy to overlook the negative heart side effects some drugs can have—and attention should be given to those as well.
As the chart at left depicts, Actos, Paxil and Zoloft accounted for the majority of 2011 traffic related to heart side effects, with Actos receiving the most at 25 percent. The Type 2 diabetes drug was released as an alternative to Avandia, which as you’ll recall came off pharmacy shelves as a result of the new FDA REMS program that became effective in November, 2011. Still, Avandia came in as the fourth most popular heart lawsuit topic.
Paxil, the popular antidepressant, has been linked to heart birth defects in infants and the drug drove in 18 percent of traffic last year. Ditto Zoloft, which accounted for 10 percent of the pageviews among readers concerned over the potential for heart birth defects.
The ten prescription drugs on the list fall into four distinct classes: Actos and Avandia are prescribed for the treatment of Type 2 Diabetes; Vytorin helps to control cholesterol, which has a direct impact on heart health; Trasylol is used during surgery to mitigate blood loss; the remaining drugs address depression and anxiety.
Reader interest in Prozac, Lexapro, Effexor, Celexa, Zoloft and Paxil shows continued concern surrounding pregnant women using selective serotonin reuptake inhibitors (SSRI) drugs and potential heart birth defects.
Here’s the full list:
Top 10 Drug Lawsuit Topics for Heart Side Effects in 2011
*SNRI (serotonin-norephinephrine reuptake inhibitor) or SSRI (selective serotonin reuptake inhibitors) drugs associated with heart birth defects when taken during pregnancy
True Story: I saw a comment from a reader here at LawyersandSettlements.com who had gone to the doctor to get some help for his acne. While there, the doctor noticed that this guy’s hair was starting to thin. Long story short, the guy walked out of the doctor’s office with a prescription for Propecia. He now claims he suffers sexual side effects (like erectile dysfunction and impotence). Oh, and btw, he still had his acne.
It got me thinking…
I’m not a glass-half-empty type, but it’s easy to see how, with prescription drugs, one can envision a worst-case-scenario downward spiral of things—especially given the potential side effects with some drugs that are on the market.
So then I started thinking, what if…
What if a guy goes to the doctor for acne. What could happen based on which drugs he’s been prescribed and what the side effects of those drugs could be? The graphic above depicts “The Snake Pit” (classic movie if you haven’t seen it) version of taking prescription upon prescription. A modern day Dante’s “Inferno”. Only in this little vignette, no one emerges from hell in their attempt to mitigate (via new prescriptions) the snowball effect of increasingly negative side effects.
Here’s how this plays out.
(Note, yes, it’s hypothetical, assumes various doctors/specialists involved, and yes, assumes worst case and/or rare scenarios…but still, it could happen. And before you get on me for Accutane being off the market, the drug isotretinoin is still alive and kicking…)
A guy goes to the doctor for acne. He’s given Accutane (isotretinoin). A possible side effect of Accutane is Inflammatory Bowel Disease (IBD). To treat the IBD, he’s given Cipro (antibiotic) and Prednisone (corticosteroid). Cipro has been linked to tendon rupture. Reported, though rare, side effects of Prednisone can include high blood pressure and osteoporosis. Assuming his luck is nil, he experiences these side effects and is given Lisinopril (ACE inhibitor) to combat the high blood pressure, and Fosamax to help combat the osteoporosis.
As we know, Lisinopril has been linked to liver damage (or worse, liver failure). And Fosamax has been under fire for femur fractures. Which, outside of pain meds—which have their own set of side effects—requires another form of medical intervention (surgery). So we come to a “STOP” on that path.
But between the Accutane and the Lisinopril, he begins to experience some hair loss as well—a rare side effect of both drugs, and he’s Mr. Unlucky. So next up, Propecia. Propecia side effects include sexual dyfunction. And he finds himself having some “issues” on the love-making front. Well, there’s a drug for that—Viagra! But let’s face it, between hair loss, sexual dysfunction, a broken thigh bone, a ruptured tendon, high blood pressure and some bowel problems, is it any wonder this guy’s now depressed? So, it’s time for some SSRI’s—like Prozac. And Prozac’s been linked to suicidal behavior.
And, with that, I guess it’s another “STOP”.
There’s a lot in the news about pregnancy and antidepressants (SSRI’s in particular—and especially Paxil, which has a Category D rating by the FDA). And we get a lot of comments and emails from readers who are either looking for information about SSRI drugs and pregnancy—or who share their stories about negative side effects they’ve experienced while taking antidepressants.
It’s a tough call—particularly when depression and pregnancy are not exactly mutually exclusive of each other. As any mom will tell you—even the ones who “just love being a mom!” and “always wanted to have at least 4 kids!”—you know who I mean—there are moments when you’re exhausted, down, emotionally drained. For many, it’s a circumstantial situation that, given a few hours, some diversions, or a good workout, tends to go away and resolve on its own. But not for everyone. And that’s where depression medication comes into play. Bottom line, it’s no accident that “Peanut Butter, Playdates & Prozac” became a popular read…
We publish a lot of information at LawyersandSettlements to help readers understand what’s going on with antidepressant lawsuits. But we also post background information as well—and for those of you who’ve written in requesting information about antidepressants and pregnancy, I’ve pulled some of our informative posts. Here they are:
Paxil Birth Defects: Baby Beware! A look at Paxil, pregnancy and depression
Antidepressant Guide: the Brands, the Generics & Who Makes Them List of antidepressant brand names and the names of their generic equivalents, and their manufacturers
Antidepressants: Know what they’re Winding you Up With Information about antidepressant drug classifications–the “umbrella” categories that antidepressant drugs fall into: SSRI, SNRI, NDRI, MAOI, and Tricyclics.
Having a Baby? Get to Know the FDA Drug Classifications Information about FDA pregnancy ratings for drugs. (Category A, Category B, Category C, Category D, and Category X—the system in which Paxil has been classified as Category D; and antidepressants like Effexor and Celexa are Category C. For those wondering, the Prozac pregnancy rating and the Zoloft pregnancy rating are both Category C at present as well).
Mom Alert: Would you want a 68% Higher Risk of Miscarriage? Study showing high rate of SSRI miscarriage risk—as well as SNRI and Tricyclic risk. Study looked at citalopram, fluoxetine, fluvoxa-mine, paroxetine, sertraline, ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine, venlafaxine, serotonin modulators, monoamine oxidase inhibitors, tetracyclic piperazino-azepines, and dopamine and norepinephrine reuptake inhibitors.
Hope this info helps—but remember, please consult your physician for medical advice about your particular situation—only your doctor(s) can advise and treat you. If you need legal help…that’s another story…
A little bomb just dropped in the form of a report out in the British Medical Journal (BMJ) regarding the antidepressant drug reboxetine. Reboxetine—brand name Edronax—is one of the drugs classified as a Selective Serotonin Reuptake Inhibitor, or SSRI, and it’s manufactured by Pfizer. According to the report, data from industry-sponsored (biased?) trials that have been published in peer-reviewed journals are misleading when it comes to reboxetine’s safety and efficacy.
How did this happen? Well, according to an article over at medscape.com, the BMJ reports that “74% of the data on patients who took part in the trials of reboxetine were not published because the findings were negative and that the data that were published about reboxetine overestimated its benefits and underestimated its harm.”
Huh?
I feel like I’m sitting in a management meeting—not at LawyersAndSettlements.com mind you—where we’ve just received the results of an employee feedback survey—that happen to suck—and we’re all trying to figure out how to save face and mitigate any fallout. What to do? LIE! Or, simply be selective in what information gets revealed…
So re: reboxetine, little bothersome details like the trial revealed that there was no significant difference in remission between reboxetine and a placebo, and that reboxetine was found to be inferior to other SSRIs such as fluoxetine (Prozac), paroxetine (Paxil) and citalopram (Celexa), just never hit the light of day. Until now.
But here is what makes me giddy with glee: reboxetine had been approved for marketing in the UK, Germany and “other European countries” according to the medscape.com article….”but did not win approval in the United States.”
Looks like the FDA got one right! Can it be so…?