Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

Friday, July 03, 2009

As You've Read Here, Acetaminophen is Dangrous

Despite the ads touting safety, Acetaminophen (aka Tylenol, Paracetamol, etc) is probably the most dangerous over the counter drug on the market. But you already knew that, didn't you?

Monday, September 22, 2008

EPA Says Rocket Fuel In Your Drinking Water Is Not A Problem

Seriously?? Does the government have any credibility left?

So we should mix up some Perchlorate baby formula with some rocket fuel water and put it in our Bisphenol-A baby bottle. Add some fluoride in their too for good measure.

EPA against limiting rocket fuel ingredient in water

Wednesday, June 25, 2008

Original Fluoride City Considers A Re-examination Of Its Safety

Grand Rapids Michigan was the first city in the world to fluoridate it's water. They even have a monument dedicated to it. Now the city in pondering whether or not it was a good idea. Some 63 years later, Grand Rapids is considering dropping fluoride from it's water due to concerns surrounding unanswered questions raised by recent studies that link fluoride to bone cancer and thyroid problems.

In the past, it has been common to stereotype the anti-fluoride movement as a group of nuts in tinfoil hats. It's getting harder and harder to do that, especially when the lead researcher of the US Government's own 2006 National Academy of Sciences report (who had been tasked with reviewing Fluoride's safety at 4ppm) noted that:
We were not able to rule out a carcinogenic effect of fluoride. We reported that fluoride exposure is plausibly associated with a number of other health effects, including neurotoxicity, gastrointestinal problems, and endocrine problems, and that even though these effects are not necessarily specific to fluoride exposure, the associations cannot be ruled out and need further study. (PDF Link)
Think about that statement, along with the fact that the government never safety tested fluoride before adding it to drinking water. The NRC report noted that the current FDA limits for water fluoridation were clearly not safe and were likely leading to an increase in bone fractures, a particular problem among the elderly. Overall, there was consensus among the committee that there is scientific evidence that under certain conditions fluoride can weaken bone and increase the risk of fractures (PDF Link).

Tuesday, April 22, 2008

Polycarbonate Pandæmonium

Well, my world got a little bit more complicated last week. It happened when I read that Health Canada, the Canadian version of the Centers For Disease Control, announced that Bisphenol-A would be declared a 'dangerous substance' as a result of an in-depth study of the chemical.

Bisphenol-A (AKA: BPA) is a chemical used in the production of polycarbonate plastic. Polycarbonate is a hard, clear plastic that is very popular in the consumer realm. It's most known for being the plastic that is used for those cool Nalgene bottles hikers (or psudo-hikers) carry around their water in.

Opps. That was probably a 'not-so-great' idea. As it turns out, several studies have shown that Bisphenol-A leaches out of polycarbonate and into whatever it contains, even at room temperature. That wouldn't be so bad if it weren't for the fact that BPA is an endocrine disruptor that mimics the hormone estrogen in humans. It has been linked to the following effects in mice:
  • Permanent changes to genital tract
  • Changes in breast tissue that predispose cells to hormones and carcinogens
  • Prostate cells become more sensitive to hormones and cancer
  • Lower bodyweight
  • Early onset of puberty (this recent phenomenon has been puzzling scientists for a some time)
  • Decline in testicular testosterone
  • Insulin resistance
  • Decreased maternal behaviors
  • Damage to eggs and chromosomes
  • Reversed the normal sex differences in brain structure and behavior
And the list goes on. Some of these effects were known as early as 1993. Finally, Health Canada stood up and said, "Um..hey guys, this stuff looks pretty bad, eh?" (something neither the CDC nor the FDA has yet to find the balls to do).

Immediately, a slew of retailers said they'd pull polycarbonate baby bottles off the shelf (Wal-Mart will only take a year to do it). Nalgene said they're abandoning the stuff (declared on the front page of their website).

So, you say, your babies drink from Pyrex bottles and you've never been hiking. So what do you care? Well it also turns out that polycarbonate film is in just about every canned good you can think of, from chicken soup to sodas. Even more disturbing is the sheer number of products I use every day which are either clearly polycarbonate, or are suspiciously like polycarbonate (which is usually designated with the recycling code [7], but not all #7's are polycarbonate. The hard, clear plastic is the dead giveaway). For example:
  • My Brita pitchers. Are they polycarbonate? They sure look like it but this site says they DO NOT contain BPA. They're made from the safe-sounding "styrene copolymer methylmethacrylate" I'll keep using them until I hear otherwise I guess.
  • My Turvis Tumblers that I drink hot tea from every night. On the website, they're proudly listed as being polycarbonate.
  • Those super-cool Rubbermaid Premier food containers....Polycarbonate (to Rubbermaid's credit, they're very upfront about the issue).
  • Compact discs and DVDs
  • Plastic dinnerware
  • Composite dental fillings (ironic...everyone went to these fearing the mercury in amalgam)
  • Some of the aluminum water bottles are lined with polycarbonate (just when you thought you got away...)
Basically, the stuff is everywhere. On the upside, we may be close to figuring out what's caused the big increase in breast cancer. On the downside, how are we going to get rid of all of it?

Tuesday, March 25, 2008

British Regulators Are Upset That GlaxoSmithKline Hid Paxil Study

UK drug regulators are upset after finding out that drug maker GlaxoSmithKline withheld a study from the public that showed their own anti-depressant Seroxat (AKA Paxil) increased the risk of suicide in teenagers by an amazing 6 TIMES! GlaxoSmithKline conducted the study in the hopes of being able to prescribe the drug to teens, but then filed it off in a dark corner of the company's library when the horrendous results appeared. British law only requires drug companies to show a drug study if it impacts any group for which the drug is or will be recommended. Since GlaxoSmithKline had not (yet) suggested that Seroxat/Paxil be prescribed to teens, they were free to shred the study. However, in the UK as in the US, doctors can prescribe drugs 'off-label' to anyone they think might benefit. It's unclear how many teens have been prescribed the drug, but the number is likely in the tens of thousands.

UK regulators are preparing to change the law to make all studies available to regulators. We'll see. Something tells me the lobbyists will have their say (Link to AP story).

Friday, March 14, 2008

Butter Flavored Popcorn Ingredient Causes Lung Cancer

The FDA announced that Diacetyl, the ingredient in microwave popcorn that gives it its buttery taste, does cause lung cancer. Multiple workers in factories that produce butter-flavored popcorn have come down with the life threatening lung disease (now known as 'popcorn lung') and at least one consumer has as well.

Many people don't know that the bag used in microwave popcorn also contains a suspected carcinogen, Perfluorooctanoic acid, or PFOA. PFOA is a primary ingredient in Teflon and is also used to coat the inside of microwave popcorn bags as well as fast food packaging materials to make them grease resistant (typically these packaging items have a glossy, wax-like surface).

These two chemicals highlight some of the dangers of eating pre-packaged foods. If you love microwave popcorn, there is a way to make it with a plain paper bag, popcorn, a couple of staples and some oil. Check out this recipe. I use this all the time in order to avoid all the salt in pre-packaged microwave popcorn and this works very well.

Tuesday, February 19, 2008

Mass Murders Linked To Antidepressant Use

The drug dealers have already started their offensive, so to balance their propaganda, I present this list.

This will (tragically) be a running archive of mass murders who have been linked to antidepressant use. Does this seem like quite a coincidence or what? Even though this Chicago Tribune article quotes psychiatrists as saying that antidepressants are "rarely linked to violence toward others", the FDA's Black Box warning (the most serious type of warning in prescription drug labeling) says that aggression and violence are side effects. Read the whole FDA warning below the list.

Dr. Michael Stone, a clinical psychiatry professor at Columbia and best known for his 'most evil' scale, allegedly maintains a 'database' of violent crimes and says that he only can find “...a handful of cases where the person was on an antidepressant.” Well to help you out with your database Dr. Stone, check out the site in the NY Times article. It has more than just a handful.
  1. Kip Kinkel (Thurston High School Shootings 5/20/1998) [Was taking Prozac]
  2. Eric Harris (Columbine High School Shootings 4/20/1999) [Was taking Luvox]. The medical records of Dylan Klebold (co-conspirator) have been sealed.
  3. Mamoru Takuma (Osaka school massacre 6/8/2001) [Was taking an unnamed antidepressant]
  4. Andrea Yates (Murdered her 5 children in a bathtub 6/20/2001) [Was taking Effexor]
  5. Cho Seung-hui (Virginia Tech Shootings 4/16/2007 ) [Was taking an unnammed antidrepressant]
  6. Robert Hawkins (Westroads Mall shootings Omaha 12/5/2007) [Was taking an unnammed antidrepressant, Most likely Prozac].
  7. Steven Kazmierczak (Northern Illinois University Shootings 2/14/2008) [Was taking Xanax, Ambien, & Prozac] Apparently stopped taking Prozac days before after complaining of feeling like a 'zombie'.
Here is the FDA Black Box warning on antidepressants:
Suicidality in Children and Adolescents (pdf)

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Insert established name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

You Should Watch for Certain Signs If Your Child is Taking an Antidepressant
• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Feeling very agitated or restless
• Panic attacks
• Difficulty sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry, or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking
• Other unusual changes in behavior or mood

Friday, February 15, 2008

Another Mass Shooting Linked To "Medication"

It should come as no surprise by now that the recent Illinois shooter was taking some (as of yet) unnamed medication and became erratic when he stopped taking them. This is a pattern we have seen time and time again, and unfortunately, are doomed to see it continue to happen. Why? Because there's still too much money to be made. I can only guess what kinds of medication this killer was on....

Monday, January 07, 2008

Generic OTC Omeprazole (Prilosec) Coming in 2008

Israeli pharmaceutical company Dexcel Pharma Technologies, has announced they will be producing generic Prilosec in 2008. The product will be exclusively marketed in the US by Perrigo, (PRGO) a major manufacturer of over-the-counter (OTC) generics for major retalilers (Wal-Mart, Target, etc)

Saturday, December 15, 2007

Over The Counter Zyrtec Will Finally Be Available To Americans

Finally, 18 years after Canada made the very popular antihistamine Zyrtec over the counter, the FDA has decided Americans are 'adult enough' to buy it without a doctor. Gone are the days when you'd have to smuggle $0.20 Zyrtec from Canada to avoid paying $2.00 for a tablet here in the US.

Of course, the FDA recommended this change the first time back in 2001, but their back room deals with the drug companies kept that from happening.

Sadly, the more you learn about the FDA's prescription regime, the more you realize it's mostly about profit protection for corporations and very little about public safety.

Friday, December 07, 2007

What Do You Know - Another Anti-Depressant Crazed Mass Murderer

It should be no surprise that the 19 year old mass-murderer Robert Hawkins who killed 8 people as well as himself was taking anti-depressants. Is anyone else seeing a pattern here or is it just me??

Thursday, December 21, 2006

FDA says aspirin is bad, (and oh, acetaminophen might kill you)

This week the FDA announced that it was proposing new changes to the labeling of over the counter (OTC) pain relievers. Included in the list of pain relievers are the following:

  • Products with Acetaminophen/Paracetamol (Brand name: Tylenol)
  • NSAIDs (Aspirin, Ibuprofen (Brand name: Advil) , Naproxen Sodium (Brand Name: Aleve)

The FDA says the change is needed because Acetaminophen can cause liver problems and NSAIDs can cause gastrointestinal bleeding. However, I think FDA is really trying to warn the public about the dangers of Acetaminophen while taking some of the spotlight off the Acetaminophen containing products by throwing out the NSAID warning at the same time.

You should know that Acetaminophen is a relatively risky OTC pain reliever. It is so risky, that Acetaminophen overdose is now the #1 cause of liver failure in the United States. Multiple liver transplants and deaths have been caused by taking too much Acetaminophen. And overdosing is not that hard when you consider how many other "cold & flu" type products contain Acetaminophen. Tylenol has long been touted as a "safe" drug, especially for children after aspirin and salicylate containing products were tenuously linked (PDF) to Reye's syndrome. However, in light of the high risk of liver damage, the use of Acetaminophen containing products should be discouraged.

Unfortunately, the FDA has opted to warn people about the relatively low NSAID risk of gastrointestinal bleeding (compared to liver failure) at the same time, thereby obscuring from the public where the real risk lies.

Monday, September 11, 2006

Another Study Says Antidepressants cause Violent Behavior

Regular readers might remember a post I did awhile back on antidepressants and how they've been shown to increase suicidal behavior. Today brings news of a new study (to be published in the Public Library of Science) that shows that the drug Paxil causes an increase in violent behavior over placebo. In the study, users of Paxil were twice as likely to have a violent episode than people who were given placebo. Unfortunately, it's the rest of society that has to pay for these violent outbursts.

Friday, May 12, 2006

Why Do We Keep Building Monsters?

This week brought another tragic violent suicidal outburst by a mentally ill teen. But far from being just another odd, sensless and tragic event, this shooting may add another data point to a trend many have been warning about for years. It is a trend that is comprised of several seemingly random shootings by teens, including (but not limited to) the following:

Columbine High School Shooting

Bishop Neumann High School shooting

Granite Hills High School shooting

Red Lake Shootings High School shootings

Thurston High School Shootings

The connection? All of the shooters were on SSRI anti-depressants. It’s possible the shooters in other mass shootings were also on anti-depressants but in many of these cases, the medical records of the shooters have been sealed.

At first, this connection might seem coincidental. Until you consider that in In 2000, the FDA issued a “black box” warning on SSRI anti-depressants. The warning states that ANTI-DEPRESSANTS INCREASE THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS! Yes, you read that right. In at least (24) different short term studies, children and adolescents who were given SSRIs for depression, OCD, or other ‘psychiatric disorders” had an increased risk of suicidal thoughts and behaviors.

And today, in an oddly coincidental story, the FDA warned that Paxil (another SSRI) ...may raise the risk of suicidal behavior in young adults.”

It is estimated that 20-30 million prescriptions are written each year for SSRIs in the United States alone. Keep in mind, a study in the International Journal Neuropsychopharmacology [September 2002;5(3):193-7] showed that placebos, i.e. “sugar pills” were slightly MORE EFFECTIVE in treating depression than SSRIs! This study reviewed 53 clinical trials comprised of 10,030 patients, so the results should cause one to question how much these drugs help.

We are quite literally gambling with the long term mental health of children and adolescents when we put them on psychotropic drugs. Don’t be fooled. The medical community barely understands the effects of SSRIs much less the long term consequences of modifying essential brain chemistry.

Tuesday, April 11, 2006

The FDA Knows No Shame

So who is the FDA working for these days? I’ll give you a hint: It’s not you

What happens when it comes to the public’s attention (10 years after the FDA is made aware) that some products from multi-million dollar food product firms (soft drinks) contain high levels of a cancer causing chemical which has been directly linked to leukemia and known as the mother of all carcinogens ?? Well, if you’re the FDA, you tell everyone that benzene isn’t really dangerous. Even though the products in question contain levels of benzene that are FOUR TIMES HIGHER than what you’ve previously stated was the maximum allowed in drinking water!

I had to chuckle at the Washington Post’s headline “Soda Safe Despite Benzene: FDA: Chemical Present in Diet Soda, but Not Harmful” Just read that statement a few times, and you’ll come to understand just how bought and paid for the FDA really is. But the “big lie” routine was not what the FDA tired at first. No, first they tired to conceal the fact. They’ve know about this non-issue for 13 years. They first said that there was some…but oh, just a tiny- tiny bit of benzene in a few soft drinks (which they refused to name), but that it was not worth worrying about. Just last week the FDA stated that the levels of benzene found were “insignificant”. Now, after the publication of a report that showed the FDA’s own studies “.. found benzene at four times the tap-water limit, on average, in 19 of 24 samples of diet soda”, the FDA is claiming their studies “overestimated the amount of benzene”.

In the mean time, Great Britain's public health agency pulled some soft drinks off the shelf due to benzene contamination . But not the FDA. The FDA claims their own studies prove the benzene levels are safe (is their safe level of benzene the same as yours ?), but just don’t ask to see the data. That’s because they’re not releasing it yet. I’m sure they’re still looking for ways to spin the results.

It is suspected that the benzene is being created by a reaction between sodium or potassium benzoate and ascorbic acid (vitamin C). I say, just avoid the benzoate all together until this and the class actions get sorted out.