Drugs/Medical Archive

Yaz, Yasmin, Gardasil: Are Young Women Just Guinea Pigs?

October 27th, 2009. By LucyC

A couple of interesting news releases came across my desk this morning: the first is about two new lawsuits filed against Bayer AG alleging the company’s birth control pills Yaz and Yasmin have caused two young women life-threatening health events. The second is about the Gardasil vaccine—more on that in a minute. 

First the Yaz lawsuits. Short version: Judith M. Woodall and Tasha Marcell allege that they sustained “severe and permanent personal injuries, pain, suffering, and emotional distress as a result of their use of Yaz.” 

To be specific, the news release states: “Ms. Woodall, a resident of Tennessee, first began using Yaz in approximately November 2008. That same month, she suffered a saddle pulmonary embolus and deep vein thrombosis. Ms. Marcell, a resident of Georgia, began taking Yaz in October 2007. She also suffered a pulmonary embolism and deep vein thrombosis shortly after she began using the medication.” Hold that thought. 

Now the Gardasil press release. One of the researchers involved in the development of the HPV vaccine spoke at a medical conference earlier this month, and instead of towing the company line—in this case the company is Merck—she is reported to have said “70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, Read the rest of this entry »

Tags: Gardasil, Yasmin, Yaz
Posted in Drugs/Medical | 1 Comment »

Shoulder Pain Pump True Stories

October 20th, 2009. By Hunter West

Individuals who suffer a shoulder injury, only to suffer through the pain and inconvenience of shoulder surgery should not have to bear even more suffering once the surgical repair is made. But they do. 

For the uninformed, the shoulder pain pump—like all pain pumps—is a device that makes fast work of delivering pain medication quickly and efficiently to relieve the suffering encountered by a shoulder surgery patient. And make no mistake—shoulder surgery is painful. Little wonder that doctors were looking for ways to deliver pain medication more efficiently than what oral pain meds are capable of. Doctors were also looking for a level of control that giving a patient a bottle filled with potent pain pills did not provide. 

The pain pump proved to be the answer: a device that delivered pain medication directly to the wound site through the insertion of a catheter, in a carefully controlled fashion. 

Shoulder pain pumps were approved by the US Food and Drug Administration (FDA) for use in soft tissue surrounding the shoulder. However they are NOT approved for delivering pain medication directly into the shoulder joint. The FDA, in fact rejected that indication when the pain pump manufacturers put it forward. 

They didn’t tell the doctors that. Doctors were, in fact led to believe that using pain pumps Read the rest of this entry »

Tags: shoulder pain pump
Posted in Drugs/Medical | No Comments »

Lasik Surgery: FDA keeping a watchful eye…

October 19th, 2009. By AbiK

Lasik surgery’s been around for a while now (since the late 80’s, with the first Lasik laser being approved for use in 1998). And reports indicate some 6,000,000+ have had Lasik. I only know of one person who’s had it done and she raves about it. So much so that I even looked into it myself, but my ophthalmologist rejected me. It was worse than being dumped. So, while I cursed him at the time, the fact that the FDA is now beginning its study of Lasik long-term effects and post-procedure “quality of life” has me feeling a little better.

But it’s also got me thinking…what’s going on? Why now? The FDA doesn’t just casually decide to start snooping around in someone’s backyard…right?

Any time the FDA starts snooping around something (and this time it’s in tandem with their sending out warning letters to 17 Lasik facilities that were not properly reporting problems with Lasik procedures) I raise an eyebrow. Yes, I’m a bit jaded in the line of work I’m in. But you have to wonder why Read the rest of this entry »

Tags: FDA, Lasik
Posted in Drugs/Medical, Emerging Issues | 2 Comments »

Yasmin and Yaz Investors File Lawsuit

October 13th, 2009. By janem

Not only is Bayer likely going to shell out millions of dollars in lawsuits filed by Yasmin and Yaz victims, now its investors are bailing.

It’s bad enough that anyone could suffer serious side effects from Yasmin or Yaz, a drug they thought was harmless, a drug used by thousands and thousands of women to prevent pregnancy. Imagine how furious you would be, knowing that so many women have suffered from this birth control pill, and that you bought into it?

On October 13, yet another lawsuit was filed against Bayer, the maker of Yasmin and Yaz, claiming the company concealed Yasmin and Yaz side effects to boost sales. Bayer has been accused of misleading investors-in this case, two pension funds for firefighters and city employees in Pennsylvania–about the value of the company by concealing the drug’s increased risks of blood clots, strokes, heart attacks, gallbladder disease, pulmonary embolisms and deep vein thrombosis (DVT).  By hiding the risks of side effects, the company allegedly defrauded investors by falsely estimating the value of the pharmaceutical company and its birth control products.

According to a report by Bloomberg News, there are currently at least 300 Yaz lawsuits or Yasmin lawsuits pending in state or federal courts throughout the US; at least 200 lawsuits over Yaz or Yasmin are consolidated in a federal MDL that is centralized in the Southern District of Illinois; and another 50 cases are consolidated in Pennsylvania state court in Philadelphia.

Tags: Yasmin, Yasmin lawsuit, Yaz
Posted in Drugs/Medical | 2 Comments »

Seroquel in the US…Seroquel in the EU…

October 9th, 2009. By AbiK

I was reading Jane’s post on drug companies’ unethical marketing tactics and thinking about Seroquel. As Jane pointed out (and as is reported over at bloomberg.com yesterday), Seroquel’s manufacturer, Astra Zeneca,

“advised its sales force to promote the antipsychotic drug Seroquel as “weight neutral” four years after company research found “clinically significant” weight gains in users, internal documents show.”

Now, given this revelation, and given Seroquel’s reported link to increased risk of diabetes, one might question what’s going on over in the EU where a panel recently gave AstraZeneca the green light for the prevention of major depression recurrence.

In a quote from the company (businessweek.com, 9/29/09),

“Following this new indication, Seroquel and Seroquel XR are the only agents approved in the European Union to treat all phases of bipolar disorder acute depressive episodes, acute manic episodes and maintenance treatment to prevent recurrence of any mood event in bipolar disorder.”

Oh, and in case you forgot, an application for the same (ie, to treat major depressive disorder) has been pending in the US since being filed in February, 2008.

Makes you wonder if the two continents across the pond from one another ever speak to one another…

Tags: Seroquel
Posted in Drugs/Medical | No Comments »