Drugs/Medical Archive

The Drugs You Get from Your Kitchen Faucet

February 18th, 2011. By Hunter West

The next time I look to buy fish—and I don’t care if it’s fresh or frozen—I’m gonna want to make sure the fish was happy before it met its ultimate end.

If that fish came from the St. Lawrence Seaway, there’s a good chance my intended dinner was, indeed happy. Probably high on Prozac.

Huh? Fish on Prozac? You’ve got to be kidding, you say. But no, the sad truth is that our fish and aquatic wildlife is on Prozac and lord knows what else from the stuff we put in the water. And we’re doing it to them…

Here’s the deal. A peer-reviewed study conducted by the Universite de Montreal together with Environment Canada and published last month in the journal Chemosphere found that fish swimming in the St. Lawrence Seaway were found to have copious amounts of antidepressants in their systems.

Most of the stuff was found in their liver. A lesser amount was found in their brains. Okay, so maybe they weren’t all that happy after all.

The least amount—and you’ll be happy to hear this—was found in muscle tissue which is typically the stuff we humans eat. UdeM professor Sebastien Sauve, a co-author of the study, said in comments published January 22^nd in the Montreal Gazette that he isn’t worried about consumers ingesting Read the rest of this entry »

Tags: drugs in water, environmental contamination, Universite de Montreal, Water contamination, water supply
Posted in Drugs/Medical, Pleading Ignorance | No Comments »

Takes a Strong, Brave Man to File a Propecia Lawsuit

February 16th, 2011. By AbiK

Think about it. To step up to the plate and serve as lead plaintiff in a Propecia class action, a man’s got to bare his sole a bit. He’s got to come out of the proverbial closet on a few things. Well, two to be exact: male pattern baldness and sexual dysfunction. How many red-blooded men—in their prime mating years (i.e., their 20’s) would have the you-know-what’s to do that?

Enter Michael Miller of Vancouver. Maybe it’s the beer, cold weather, ‘BC bud’, or just the sheer sense of humor of our neighbors in the Great White North that brings a man—a young man—to lead a pack of over 80 Canadian men in charging Merck Frosst Canada with failing to adequately warn Canadians of the possible risks associated with taking Propecia. (By the way, Propecia is also known by another brand name, Proscar; both are the generic drug Finasteride.)

Miller is apparently quite open in sharing his tale of woe. Seems he was noticing some hair thinning going on (those of you who’ve been to your five or ten year high school reunion have no problem visualizing this). So Miller’s doctor put him on Proscar (Propecia). And about a month later, he experienced what’s possibly a twentysomething’s worst nightmare: he lost interest in sex.

According to the release put out by his law firm, Klein Lyons, Miller stated, “I lost my interest in sex and I felt anxious in social situations for no particular reason.” He also says that after stopping Proscar, the symptoms did not go away: “My sexual functioning has not recovered, I have seen specialists and have tried treatments but nothing has worked.”

All kdding about male prowess aside, it’s one thing to have adverse side effects from a drug and know that they are non-life-altering and circumstantial—that they’ll only be present during the Read the rest of this entry »

Tags: Class Action, Erectile Dysfunction, Finasteride, Propecia, propecia-proscar-sexual-dysfunction-class, Proscar, Sexual Dysfunction
Posted in Drugs/Medical, Emerging Issues | No Comments »

Could Wipes have Killed an Innocent Child?

February 16th, 2011. By LucyC

On December 1st, 2010, two-year old Harrison Kothari died from a rare infection while in the hospital recovering from surgery. As if this weren’t bad enough, the kicker is the very real possibility that the infection, acute bacterial meningitis caused by Bacillus cereus, and his subsequent death could have been prevented. So Harrison’s parents are suing the makers of Triad Alcohol Prep Pads, which the hospital used on their son in late 2010, but which were subsequently recalled on January 5^th 2011 due to contamination with Bacillus cereus.

While hospitals are infamous incubators of a host of bacterial illnesses, acute bacterial meningitis is not one of them. Rather, Bacillus cereus is typically found in rare food poisoning outbreaks. Hospital officials were at a loss to explain how Harrison had contracted the infection. “They had no explanation as to how he contracted it,” Sandra Kothari, 37, Harrison’s mother told msnbc.com. “They know it’s rare in the hospital.”

Then, in January, a relative caught sight of the recall notice for the alcohol wipes and swabs on the US Food and Drug Administration (FDA) website, which reads:  

“Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.” 

 “These wipes were used in his [Harrison’s] care every single day, multiple times a day,” Harrison’s father, 38-year old Shanoop Kothari, told msnbc.com. And officials at the hospital have confirmed that those alcohol prep products were supplied by Triad.

 “We’re confident that that’s the cause,” said Kothari. “There was no other explanation that made any sort of sense. He contracted a very rare bacteria. These swatches were tainted with that bacteria.”

This week lawyers representing the Kotharis filed a complaint in U.S. District Court in Houston, charging the Triad Group with gross negligence and seeking damages for the loss of Harrison’s life.

“Our emotional response over this has been horrible,” said Shanoop Kothari said of his family, which also includes Harrison’s 7-year-old sister, Hannah. “We’ve been devastated. We’ve been absolutely crushed.”

This tragic situation brings to light a larger problem: according to FDA spokesperson, Christopher Kelly, who spoke with msnbc.com about this matter, Triad, a 35-year old family run company, “did everything correctly” in notifying government authorities about the recall. The recalled products are reportedly also sold under private labels in Canada and Europe, as well as the US. So what does this mean for you and me—woe betide us if we do not regularly monitor the FDA website?

Understandably, Sandra Kothari is worried that others may have been injured, infected or killed as a result of exposure to these products. “I wouldn’t want any other mother to go what I’ve gone through,” she told msnbc. And it’s possible. To be clear, these wipes and swabs were widely used in hospitals and, “sold in stores including CVS and Walgreens. “People buy alcohol pads and they last a long time in your bathroom. They’re sitting there now,” she said.

The recall notice states the following:

“The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin. 

A final caveat—in case you’re wondering whether Harrison had received his bacterial meningitis vaccine—the answer is no—he wasn’t quite old enough at the time he underwent surgery. And even if he had had the vaccine, it doesn’t protect against that strain of the bacteria.

Read the Triad alcohol swab recall notice here.

Tags: Bacillus cereus, Harrison Kothari, Negligence, Triad Alcohol Swab, Wrongful Death
Posted in Defective Products, Drugs/Medical | 2 Comments »

From Medical Misdiagnosis to Sexual Assault of a Minor – the Story of Michelle Francoeur

February 8th, 2011. By LucyC

Have you heard of Michelle Francoeur? A teacher in small-town Canada recently found not criminally responsible for sexual assault of a minor due to mental illness—mental illness that was misdiagnosed and mistreated, as it turned out. Francoeur’s story may not have been front and center in main stream media—but it reads like a best-seller.

In 2008, the then 37-year old teacher of kindergarten through grade nine and mother of two young children began experiencing health problems. So she went to her doctor, and was subsequently diagnosed with depression. She was prescribed an antidepressant medication known as Effexor or venlafaxine. And this is when her problems began.

During the next few months Francoeur’s behaviour underwent a ‘radical change’. For example, she began drinking alcohol excessively, spent money carelessly, went days without sleeping, failed to eat regularly, and consequently suffered significant weight loss, and talked excessively. Worse, the jury that recently heard her case was told by Francoeur’s defense lawyer, she began taking shortcuts in caring for her two daughters aged five and seven.

And at some point over the next few months she began a series of sexual encounters with a 15-year old ex-student. This marked lack in judgement resulted in her being charged with sexual assault. And presumably, the loss of her job, and income.

As it turned out, the boy initiated the relationship with Francoeur—if you can call it that—by sending her a ‘flirtatious’ text message. That led to several ‘sexual encounters,’ between them before the boy’s parents cottoned on.

During this period, Francoeur’s family members had become very concerned about her behavior, and contacted Francoeur’s doctor, by letter. Somewhere, somehow, this must have led to a revisitation of the original diagnosis, because Michelle was re-assessed and subsequently diagnosed with bipolar disorder. And this is key, because the medication she was prescribed—Effexor—is known to escalate the “manic” phase experienced by people with bipolar disorder. The manic phase is characterized by extreme feelings of elation, euphoria, racing thoughts, inability to sleep and difficulty appreciating consequences.

Francoeur’s lawyer, Aaron Fox, summed up the situation pretty well, when he told the Canadian Broadcasting Corporation “It was a “very tragic circumstance…It was a lady who has an underlying condition which was misdiagnosed and received medication that really had a catastrophic effect on her.”

Problem is, even though Francoeur’s been acquitted, damage has been done, to her reputation, her self esteem, and very possibly her career as a teacher. Certainly, going back to teaching in the town of Shell Lake, Saskatchewan, with a reported population of less than 200, could pose some problems.

All this from a misdiagnosis which led to a disastrous choice of medication in her circumstance.

Needless to say, Francoeur’s story raises a number of concerns, such as how many others may have been misdiagnosed like Michelle, and suffering as a consequence? Was Francoeur warned of the possible adverse effects of the drug?

And what about the physician—does his misdiagnosis constitute medical malpractice? Just how much responsibility does he or she bear in all this? After all, this entire situation may have been avoided had she not been prescribed an incorrect medication.

Answers may be forthcoming—or not. It all depends on what, if anything, Francoeur decides to do. For now, she must be quite relieved to have her name cleared, to be out of the spotlight—and most importantly—know she has been correctly diagnosed and appropriately treated, so she can get on with her life and redefining ‘normal’.

Tags: Antidepressant, Effexor, effexor-heart-birth-defects, medical malpractice
Posted in Drugs/Medical | 7 Comments »

Christmas Comes Early for Medical Device Manufacturers, FDA Plays Santa Claus

January 31st, 2011. By Hunter West

It was recently that the US Food and Drug Administration (FDA), the government agency charged with responsibility over drugs and medical devices in this country, is seeking to further streamline the review, and approval of medical devices.

Can you hear the cries of joy in the medical device manufacturing heartland?

Well, not entirely. The FDA is also thinking of creating a new category of devices that would require more data than is currently required for approval. That would make it tougher for medical device manufacturers to get new products to market.

Oh, but according to a report by Reuters appearing January 19^th in The New York Times, the FDA is going to defer that idea for a period of time. Which is a good thing, I guess, because the device industry was worried that such a change would slow the progress of devices to market. Devices that can now take advantage of an increasingly streamlined process.

That process—which the FDA is looking to expand, while deferring any effort that might make it tougher for device manufacturers—holds that if a manufacturer seeks approval for a new product that is substantially similar to an existing product already on the market, it can take advantage of a streamlined approval process requiring less scrutiny and testing.

Naturally, that’s a win for the device manufacturers. One spokesperson for a major manufacturer called the news of an expansion of streamlined approvals, and the deferral of tougher policy a more ‘balanced’ approach that shows the FDA is engaged, listening and concerned.

Yes—but to whom is the FDA really listening? And about whom are they really concerned?

It sounds to me like the FDA’s greatest role is to assist device manufacturers (and drug companies).

Is the FDA not a government agency, whose mandate is to first and foremost represent and protect Read the rest of this entry »

Tags: FDA, medical devices
Posted in Drugs/Medical | No Comments »