Drugs/Medical Archive

Startling Study: 91% Canadians have BPA in their Urine

August 19th, 2010. By Hunter West

It may be the title and a line from a romantic Peter Frampton song, but in this context it is anything but endearing. 

I’m In You… 

In this case, you’d rather the suitor not—especially Canadians who learned on Monday that according to a national survey through the analysis of thousands of representative samples, 91 percent of the population of Canada is found to have bisphenol A (BPA) in their urine. 

The good news is that BPA is excreted from the body after about six hours. But here’s the bad news: such a high percentage suggests that Canadians are exposed to BPA on a regular basis and from a variety of sources. What’s more, according to a report from the Canadian Broadcasting Corporation (CBC), the findings mirror those of other international studies. 

So it’s something we all have to fret about. 

BPA was banned from baby bottles some time ago—and therein lay the most serious concern over the man-made substance. Some studies on animals suggest that low levels of exposure to BPA very early in life can affect brain development and behavior, but scientists are unsure how these findings might be relevant to human health, according to Statistics Canada. 

But baby bottles aside, BPA lurks in a lot of other stuff, too: water bottles and Read the rest of this entry »

Tags: BPA
Posted in Drugs/Medical, Environment | No Comments »

Campaign for Safe Cosmetics Video – Real Issues or Just Hype?

August 17th, 2010. By AbiK

Ok, it’s now big enough and viral enough that Cosmetics Design has even reported on it…

The Story of Stuff’s latest video on youtube.com, “The Story of Cosmetics” (above, and yes, it’s eight minutes long), has already gotten over 203,000 views. It’s not only timely because it was released on July 21st, but also because it basically rides on the coattails of the recently introduced in Congress Safe Cosmetics Act of 2010. The Act states that it will give the U.S. Food and Drug Administration authority to ensure that personal care products are free of harmful ingredients.

A long time coming, yes. Heck, no one wants to put questionable ingredients or suspected carcinogens on their faces or the skin of their loved ones (I’m talking infants here, not massage lotions).

But while cosmetics industry groups—such as the Personal Care Products Council (PCPC)—have also called for more stringent controls on cosmetic ingredients, the PCPC has dubbed “The Story of Cosmetics” a “shockumentary”.

What do you make of it?

Tags: Cosmetic Ingredients, FDA, Safe Cosmetics Act
Posted in Consumer Fraud, Drugs/Medical, Personal Injury | 2 Comments »

The Latest Botox Buzz: ‘Teen Toxing’

August 12th, 2010. By Hunter West

Am I missing something here? 

The last time I checked, cosmetic Botox was approved for wrinkles in the brow between the eyes. 

That’s it. Oh, there are other approved medical uses for Botox—therapeutically in children as young as 12 with abnormal twitching of the eyelid or crossed eyes. It can also help patients 16 and older with involuntary contraction of neck muscles, and by people 18 and up to combat excessive sweating..

However, cosmetically Botox has an extremely limited footprint (or face print, if you will) according to the original approval for cosmetic purposes by the US Food and Drug Administration (FDA). 

Does that surprise you? 

Little wonders that it does, given the astounding degree to which Botox is used off-label cosmetically. 

It’s outrageous. According to the American Society of Plastic Surgeons, outline toxin—which is Read the rest of this entry »

Tags: Botox
Posted in Drugs/Medical | 3 Comments »

Depakote Studies Need Cautionary Notes for Pregnant Women

July 27th, 2010. By janem

Some reports put Depakote in a more favorable light over other epilepsy drugs because there isn’t an increased risk of self-harm of suicidal behavior as reported in similar epilepsy meds. But such reports can also be dangerous if read by a soon-to-be pregnant woman or worse, an already pregnant woman on Depakote, because they often neglect to mention that the drug has been linked to Depakote birth defects.

Or perhaps a physician will read these reports and focus only on Depakote and its link to depression, bypassing its association to birth defects.

For instance, a recent UK study (Neurology, July 27, 2010) revealed that those who took relatively new antiepileptic drugs with a higher risk of causing depression, (such as levetiracetam (Keppra), topiramate (Topamax) and vigabatrin (Sabril) were three times more likely to harm themselves or attempt suicide than those who weren’t taking any epilepsy medications. The researchers found that patients who took conventional epilepsy medications, such as divalproex (Depakote, Depakote ER, Depakene) faced no increased risk of self-harm of suicidal behavior.

The Journal of the American Academy of Physician Assistants (July 29, 2010) reported that Depakote, when used as a mood stabilizer in adults with acute bipolar depression, decreases depression symptoms by at least 50 percent in at least one additional patient of every 10 patients who are given treatment instead of placebo. Again, no cautionary words for pregnant women.

Perhaps such studies should list alternative anti-epileptic medications.

But two studies presented at the beginning of July –the UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy (EURAP)– found that Depakote and other valproate-based antiepileptic drugs were more than twice as likely to cause major congenital malformations when used by pregnant women than Tegretol (carbamazepine) and Lamictal (lamotrigine), with an overall risk of more than 6 percent.

The EURAP study set the odds of a Depakote birth defect at 9 percent. While those odds sound risky, a study done in 2006 found that about 20 percent of babies born to mothers taking Depakote suffered serious problems, as opposed to other drugs which only had rates anywhere between 1 and 10.7 percent. (Depakote was slapped with a black box warning in 2006). Clearly, the risk of Depakote outweighs the benefits, when it comes to the possibility of a pregnant woman suffering a seizure. After all, there are alternative and much safer medications.

Tags: depakote, depakote birth defects, depakote pregnancy, depakote side effects
Posted in Drugs/Medical | 1 Comment »

How the FDA Advisory Panel Vote Affects Avandia Patients

July 15th, 2010. By Kristine B

If you’re like other Avandia patients out there, you probably waited for the FDA advisory panel’s vote yesterday with some concern (or maybe you didn’t). Yesterday was the day the FDA advisory panel voted on whether or not to remove Avandia from the market. So, today we examine how the panel voted and what that means for you.

First, what you need to know about the panel. The panel is only advisory. This means that the FDA doesn’t have to follow the panel’s recommendations. Sure, it usually does, but that doesn’t mean it always will. So, all the panel can do is make recommendations. Whether those recommendations will be followed is up to the FDA.

So, what did the panel recommend? Well, depending on how you view it (and whose articles you read) Avandia was either dealt a severe blow by the FDA or won a major victory. Hunter’s Avandia post today calls it a “muted win” for GSK, which probably sums it up best.

On the question of what to do with Avandia, panel members voted as follows:

12 voted to withdraw the drug entirely

10 voted to allow it to remain on the market with strong label revisions and possible sales restrictions

7 voted to add further warnings to Avandia’s label

3 voted to allow continued sale of Avandia with no changes

1 abstained

So, there are two ways of looking at this: Either the majority of panelists (22) voted to either withdraw Avandia from the market entirely or only allow it under stronger warnings and sales restrictions, or the majority of panelists (20) voted to keep Avandia on the market rather than withdrawing it. Nothing is ever simple when it comes to pharmaceutical decisions.

What does that mean for patients taking Avandia? Right now, it doesn’t mean anything. You haven’t been told to stop taking the drug, although 18 panel members voted that they are concerned Avandia causes heart attacks (nine said they weren’t sure about the risk of heart attacks and six said they weren’t concerned about the risk of heart attacks).

So, if you’re concerned about taking Avandia, you should speak with your doctor about the risks. But don’t stop taking it without first speaking to your doctor about your concerns.

The FDA will make a decision later about whether or not to continue to allow Avandia on the market.

Meanwhile, GlaxoSmithKline has reportedly settled 10,000 Avandia lawsuits for approximately $460 million. If you think you may have an Avandia claim, your best bet is to file your claim with a lawyer who is specializing in Avandia claims.

Tags: Avandia, Avandia Lawsuit, FDA, GSK, Pleading Ignorance
Posted in Drugs/Medical, Emerging Issues | No Comments »