Drugs/Medical Archive

Mom Alert: Would you want a 68% Higher Risk of Miscarriage?

June 2nd, 2010. By LucyC

A new study out yesterday—June 1, 2010—has revealed a higher rate of miscarriages in women who were taking antidepressants during pregnancy. How much higher? Sixty-eight percent—yes —that’s 68%—higher. Frankly, that is nothing short of shocking.

Published in the Canadian Medical Association Journal, the study was done in Canada through the University of Montreal. FYI—This was no small study either—the investigators used data from 5,124 women who are part of a large, population-based study of pregnant women who had clinically verified miscarriages, and a large sample of women from the same registry who did not have a miscarriage. Among the women who miscarried, 284 or 5.5 percent, had taken antidepressants during their pregnancy.

In fact the findings are so robust that the physicians who did the study are suggesting that this is a class effect—in other words the effect could be attributed to all selective serotonin reuptake inhibitors—or SSRIs. Here’s what’s being reported in the press:

“These results, which suggest an overall class effect of selective serotonin reuptake inhibitors, are highly robust given the large number of users studied,” the study’s senior author, Dr. Anick Berard, said in a statement. (UPI.com)

The antidepressants that showed a particular association with miscarriage in the study were paroxetine (trade names: Seroxat and Paxil) and venlafaxine (trade names: Effexor, Efexor, Alventa, Argofan, Trevilor). The investigators also found that the risk of miscarriage doubled with a combination of different antidepressants.

Just for the record, the antidepressants “investigated” in the University of Montreal study are serotonin reuptake inhibitors (citalopram, fluoxetine, fluvoxa-mine, paroxetine and sertraline); tricyclic antidepressants (ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine), Read the rest of this entry »

Tags: Celexa, Cymbalta, Effexor, Lexapro, paxil, paxil-heart-defects-newborn, Prozac, SNRI, SSRI, Zoloft
Posted in Drugs/Medical | No Comments »

Fosamax Femur Fractures in Media Spotlight

June 1st, 2010. By janem

I feel sorry for health officials and researchers whose warnings about adverse drug reactions fall on deaf ears; if only they could employ TV anchor Diane Sawyer to heighten public awareness. Case in point: the link between Fosamax and femur fractures.

Since 2008 researchers have suggested that patients-especially women–using Fosamax may be at risk for increased risk of bone fracture. Although the femur is the strongest and biggest bone in the body, a number of Fosamax patients have fractured their femurs simply from from walking. You can watch Diane Sawyer’s investigation and a follow-up report on ABC News here.

But not even Diane Sawyer and the media can budge the FDA. It says a warning to doctors at this point isn’t justified, but they will “seriously look into it”. That’s good news for Merck.  But if the agency sends a letter to doctors, it would allow them to get data they need to have Merck slap a femur fracture warning on the drug. Merck has likely banked heavily on Fosamax profits, especially given the age of baby boomers…

Back to those researchers. In 2008 Cornell University Medical School researchers showed that Fosamax patients are more than 125 times as likely to suffer non-traumatic femur fractures than patients who have not taken Fosamax. And there have been more studies to back-up Cornell.

At first, Fosamax prevents bone loss but loss over time it may also limit the bone’s natural ability to protect itself from stress. A rheumatologist at National Rehabilitation Hospital in Washington DC said that in up to 60 cases he looked at, most patients had been taking Fosamax or another type of bisphosphonate for more than five years.  Potentially, many women who have taken Fosamax for 5 years or more can be walking around with brittle bones that can fracture at any time.

Here’s the clincher: on its website, Merck, the Fosamax manufacturer, says that “…after you start taking Fosamax, even though you won’t see or feel a difference and that for fosamax to continue to work, you need to keep taking it. From what I could glean, none of Merck’s clinical trials lasted more than four years. So how long does Merck want you to take it for?

For that matter, should any drug be taken longer than indicated in clinical trials? After all, the drug was approved based on most trials from 1-2 years. When it was initially approved, Merck stated that “side effects observed in clinical trials were generally mild. The most commonly reported drug-related side effects in subjects taking Fosamax were abdominal and musculoskeletal.

Recent label changes made Merck add the following: bone, joint, and/or muscle pain, occasionally severe, and rarely incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures. But who reads that? Thanks, Ms. Sawyer.

Tags: femur fracture, Fosamax, fosamax femur
Posted in Drugs/Medical | 17 Comments »

Join me as I Submit my United Healthcare Out of Network Claim

May 26th, 2010. By AbiK

The much-anticipated Notice of Proposed Settlement for the United Healthcare (UHC) class action lawsuit about Out-of-Network (OON) charges being improperly reimbursed has finally landed in my mailbox—perhaps yours, too.

Chances are, if you’ve received the UHC OON settlement notice, you glazed over it and tossed it aside while simultaneously feeling some sort of nagging inside—that nagging you feel when you know you should do something but it’s just too much of a pain in the ass to do it. Windexing the windows falls into this category as well. The difference between the windows and the UHC settlement though is that at least you KNOW how to do the windows; just try to figure out how to submit a claim for this settlement.

So I’m going to go through the process with you—yes, I’m going to fill out the paperwork and post about it so I can feel your pain and hopefully help you make sense of it all along the way. And so our little journey begins…

My UHC Out of Network Settlement Experience: DAY 1

The UHC OON Proposed Settlement in hand, I rip it open to find a sea of text that immediately starts to confuse me. It’s not the lawsuit I’m confused about—we’ve followed the AMA v. UHC class action. It’s what the heck I need to do now. So I force myself to read the hideously dense serif text and here’s what I need to do:

1. Ask myself, was I a United Healthcare Subscriber…

at all between March 15, 1994 through November 18, 2009? Ok, yes, I was.

2. How long do I have to submit a Claim Form for this?

(i.e., how long can I procrastinate?) I have until October 5, 2010 to submit a UHC settlement Read the rest of this entry »

Tags: OON, out of network, Out of Pocket, UHC, United Healthcare
Posted in Drugs/Medical, Emerging Issues, Insurance, Settlement | 231 Comments »

How Does the Avandia Settlement & TIDE Trial Affect Me?

May 18th, 2010. By Kristine B

If you’ve read the news lately, you may have heard that GlaxoSmithKline agreed to settle approximately 700 Avandia lawsuits for a reported $60 million. You may also have heard the calls to end the Avandia safety trial known as the TIDE trial. This may have you concerned about how these developments affect you, and rightfully so.

This week, Pleading Ignorance takes a look at how the Avandia settlement and the controversy over the Avandia and Actos TIDE trial may affect you.

Avandia Settlement

GlaxoSmithKline has reportedly agreed to settle 700 lawsuits for approximately $60 million. How this settlement affects you depends on where you are in the lawsuit process, if you are involved at all.

Obviously, if you’re one of the 700 lawsuits that have been settled, then your lawsuit is now done; you’ll receive your share of the settlement and no longer have to worry about the litigation.

If you are one of the remaining lawsuits (reported to number in the thousands), how this settlement affects you is less clear. Details about the settlement have been kept quiet. Based on how big businesses operate, my guess (this is just speculation here) is that GlaxoSmithKline has not admitted to any wrongdoing (something most businesses attach to their settlements). The settlement, however, shows that the drug maker is willing to sit down with plaintiff’s lawyers to negotiate, which could be a good thing for the remaining lawsuits.

That said, there is no guarantee that a settlement in those 700 initial lawsuits will translate into a settlement for the remaining lawsuits. It’s a good sign, but it’s no guarantee.

If you are considering contacting a lawyer but haven’t done so yet, the statute of limitations might be running out for you. One of the things that plays into how much time you have to file is whether or not your state follows a discovery rule. What’s that? Basically, it’s the point in time in which an individual would have likely been aware that a claim could be made against a defendant—or that a claim existed. In the case of Avandia, that would mean the point at which a person most likely knew they Read the rest of this entry »

Tags: Actos, Avandia, Avandia Settlement, Glaxo, GSK, TIDE
Posted in Drugs/Medical | 16 Comments »

Yaz by the Numbers: the Warning, the Recall, the Profit, the Lawsuits

May 12th, 2010. By Kristine B

As Bayer adds new warnings to its birth control pills in the wake of lawsuits regarding Yaz and Yasmin, we thought it would be a good idea to break Yasmin and Yaz down by the numbers. 

2001: The year Yasmin came on the market

2006: The year Yaz came on the market

2008: The year Bayer (maker of Yasmin and Yaz) received a warning from the FDA about overstating the pills’ effectiveness while minimizing their risks

2008: The year Ocella receives FDA approval; Ocella is the generic version of Yaz that is manufactured by Barr, which is owned by Teva

2009: The year Bayer launches new $20 million ad campaign to address the FDA’s warning

2009: The year the FDA issued a recall on certain lots of Yaz and Ocella for “Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.”

2010: The year Bayer added new warnings about the risks of blood clots linked to Yasmin and Yaz

1,100: Approximate number of lawsuits filed against Bayer regarding Yasmin and Yaz

$1.64 billion: Approximate profit Bayer reportedly made from Yasmin and Yaz during 2009

993: Number of reports the FDA received by November, 2009, of cases of pulmonary embolism linked to Yaz or Yasmin

487: Number of reports the FDA received of deep vein thrombosis

229: Number of reports the FDA received of other blood clots

800: Number of Canadians who have joined class-action lawsuits against Bayer

50: Number of women who reportedly died after taking Yaz, as of July, 2009

6.3: The number of times the risk of developing a blood clot is increased in women who take Yasmin or Yaz, according to a study in the British Medical Journal.

Note: Bayer has defended the birth control pills, saying they are safe and effective.

All stats taken from the FDA.gov, The New York Times, Los Angeles Times, Calgary Herald, BusinessWeek, The Bulletin (Philadelphia) and WISH tv, in addition to the British Medical Journal.

Tags: Birth Control, Contraceptive, Ocella, Yasmin, Yaz
Posted in Drugs/Medical | No Comments »