May 12th, 2009 by RamonaBatesMD in Better Health Network
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The U.S. Food and Drug Administration recently announced that safety label changes including a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) will now be required for all botulinum toxin products. The agency took the action because of two main reasons. The first one is the potential for serious risks that may occur from the spread of the botulinum toxin beyond the injection site. The second reason is associated with the lack of interchangeability among the three licensed botulinum toxin products.
When the botulinum toxin spreads beyond the area of injection, symptoms similar to botulism may occur. These symptoms include unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
This “spreading effect” has been reported in both children and adults. It has been reported most often in children with cerebral palsy being treated with the products for muscle spasticity. Treatment of muscle spasticity is an off-label use of the drug. The “spreading effect” has been reported in patients being treated for both approved and unapproved uses.
Botulinum toxin products include:
-
Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan
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Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences
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Dysport (abobotulinumtoxinA), a new FDA-approved product marketed by Ipsen Biopharm Ltd.
All are approved by the FDA for the treatment of cervical dystonia. Botox Cosmetic and Dysport are approved by the FDA for treatment of glabellar frown lines. Botox is approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm). All other uses are considered off-label.
The FDA has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when these products are used in accordance with the approved label.
It is important for those of us who use botulinum toxins to remember that the dosage strength between the products is not the same. One unit of Botox is not equal in strength (potency) as one unit of Myobloc or Dysport.
BOTOX® Cosmetic Insert (pdf)
Dilution Technique: Using a 21-gauge needle and an appropriately sized syringe draw up a total of 2.5 mL/100 Unit vial or 1.25 mL/50 Unit vial of 0.9% sterile saline without a preservative…….
Injection Technique: Glabellar
Using a 30-gauge needle, inject a dose of 0.1 mL into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units. Typically the initial doses of reconstituted BOTOX® Cosmetic induce chemical denervation of the injected muscles one to two days after injection, increasing in intensity during the first week.
MYOBLOC® Insert (pdf)
The recommended initial dose of MYOBLOC® for patients with a prior history of tolerating botulinum toxin injections is 2500 to 5000 U divided among affected muscles. Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dose. The duration of effect in patients responding to MYOBLOC® treatment has been observed in studies to be between 12 and 16 weeks at doses of 5000 U or 10,000 U.
Dysport® Insert
The units of Dysport are specific to the preparation and are not interchangeable with other preparations of botulinum toxin.
Glabellar lines Dosage
The dosage is dependant on the severity of the lines and the specific muscle being treated.
For the corrugator and procerus muscles 40 to 60 units divided between injection sites as follows:
8 to 12 units in each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 60 units
Improvement of severity of glabellar lines generally occurs within 72 hours after treatment and persists for 3 to 6 months.
It is important for us to educate patients and their caregivers of the potential adverse effects. Some of these effects have been reported as early as several hours and as late as several weeks after treatment. Patients should seek immediate medical attention if they develop any of these symptoms — unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
Adverse events may be reported by health care professionals and/or consumers to the FDA’s MedWatch Adverse Event Reporting program by four ways:
REFERENCES
FDA News (April 30, 2009)
BOTOX® Injections; eMedicine Article, Sept 25, 2008; Robert A Hauser, MD, MBA, Mervat Wahba, MD, Theresa McClain, MSN, ARNP
*This blog post was originally published at Suture for a Living*
May 12th, 2009 by Nancy Brown, Ph.D. in Better Health Network
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Last year the Centers for Disease Control and Prevention (CDC) announced that there were 40 percent more new HIV infections each year than was previously believed. And yet, a new (2009) survey by the Kaiser Family Foundation has found that Americans, even those in the high risk groups for HIV, are worrying less about HIV/AIDS. How can this be?
The survey suggests that:
- Fewer Americans consider HIV an urgent health problem.
- Only 17 percent of people aged 18-29 (those traditionally the most sexually active) reported that they were personally very concerned about becoming infected with HIV.
- In spite of HIV rates being seven times higher among African Americans, personal concern about HIV has decreased in this population.
- More than half of people aged 18-29 have not been tested for HIV, in spite of the fact that the CDC now recommends HIV testing for all adults.
The survey also found that misinformation and stigma about people living with HIV still exist.
- Although 44 percent of the 2,554 adults surveyed reported that they would be comfortable with a coworker who had HIV, 51 percent would be uncomfortable having their food prepared by someone who was HIV positive.
- One-third of the people surveyed incorrectly believed that HIV could be transmitted by sharing a glass of water; touching a toilet seat; or swimming in a pool with an HIV positive person.
- 18 percent believed there was a cure for HIV and 24 percent believed there was a vaccine available to prevent HIV.
This is scary stuff and suggests that families, parents, schools, and medical professionals have their work cut out for them – more HIV education, please!
This post, Why Aren’t We Worrying About HIV Anymore?, was originally published on
Healthine.com by Nancy Brown, Ph.D..
May 12th, 2009 by Emergiblog in Better Health Network, True Stories
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I love this ad.
I was about this age when I decided to become a nurse.
Maybe a little older.
I was holding a book instead of a teddy bear.
I wouldn’t have been caught dead in that cap, though. Even in those days I knew how to make a totally cool nursing cap out of paper.
That looks like a pillowcase.
Sometimes it’s hard to remember why nursing sounded like a good idea.
********************
You don’t realize it’s happening.
You set a goal and you do what you have to do to get there.
For awhile, you manage to do it all.
Nine semester units.
Working 24 hours a week.
No sweat.
Been there, done that.
Lived through it.
*****
But things start piling up.
Work needs you to pick up some hours. Coworkers on leave, folks needing time off.
You say yes, because when you need time off, they will make sure you get it.
Only your body isn’t cooperating.
You are in bed for the night at 1600.
And up at 0530.
Then you can’t fall asleep before you go in at 1900.
So you’re up for 28 hours. Straight.
Twice in one week.
That worked when you were eighteen.
It kills you at fifty-one.
*****
So you work, and work is uncharacteristically busy.
You start getting depressed four hours before you go in.
Then you start getting depressed because you have to work the next day.
Your coworkers are getting on your nerves.
You are really getting on their nerves.
You hit the ground and twelve hours later you sit for the first time. In the car. For the ride home.
To sleep for ten hours so you can go back and do it again.
Before your one day off.
That you sleep through.
*****
You fall behind in class; the professors are cool and allow you extra time for the assignments.
Which you need because you are so exhausted you cannot think.
But you won’t give less than an “A” effort so you stress and research and study and fine-tune and finally turn in the missive 48 hours after it is due.
Only to discover your classmates managed the assignment in two paragraphs.
How the hell did they do that?
*****
You start to lose it.
You don’t leave the house on your time off.
You stay in sweats all day and don’t bother to fix your hair.
Your husband thinks you are having a breakdown because he hears you laughing hysterically one minute and bursting into tears the next.
Except it’s not a breakdown, you are just watching “Scrubs”.
(Why the hell did they kill off LaVerne? Idiots.)
You start scanning the ads for a desk job. Part-time. Days. No weekends.
No blood. No pain.
No death.
*****
I’ve been here before.
The demon is back.
I’m in full blown burn-out.
But no major life changes.
Not this time.
I know what to do.
No more extra shifts.
The money is nice. Sanity is nicer.
No more twelve-hour shifts. Kudos to those who can do them.
I can’t.
No summer school.
I’m 12 units away from a BSN. I can graduate in the Spring of 2010. I gain nothing by sacrificing my mental health to do it by December.
*****
I’m scaling back, I’m taking a break.
For the next few months, it’s all about me.
More visits to Starbucks to read blogs.
More visits to Starbucks to read novels.
More concerts.
More mini-vacations. Son’s graduation. Nascar race in Sonoma. BlogHer in Chicago.
*****
I wish I could do it all and be it all and have it all.
It’s hard to face the fact that I have limitations.
But, I know,
I’m no Superman.
And that is a major bummer.
I’m No Superman
*This blog post was originally published at Emergiblog*
May 12th, 2009 by admin in Better Health Network, News
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I really don’t think the cholesterol lowering effects of Cheerios are comparable to how a drug may help lower cholesterol, but the Food and Drug Administration (FDA) is saying that the claims Cheerios is making on it’s boxes are similar to those made by drug companies. And, by the way, it is against the law. The FDA sent General Mills a letter (read the whole letter here) saying that the phrases they are using on their packages and website are misleading consumers.
Here is snapshot of what FDA said in their letter:
Unapproved New Drug
Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims on its label:
• “you can Lower Your Cholesterol 4% in 6 weeks”
• “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”
These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and “bad” (LDL) cholesterol.
You may or may not think this is a big deal, but I can tell you that the FDA takes health claims seriously. There are only certain FDA approved claims that food companies are allowed to make on a product label. In this letter they also included the website as part of the label since the web address www.wholegrainnation.com is listed there. So that means that everything on the website also needs to comply with the official FDA health claims.
Cheerios is a great cereal that is low in sugar and has soluble fiber. I am sure they will correct their language to comply with the FDA’s request and this will blow over. Keep eating your Cheerios with low fat milk and a handful of blueberries. Yum!
This post, Cheerios: A Drug?, was originally published on
Healthine.com by Brian Westphal.
May 11th, 2009 by EvanFalchukJD in Better Health Network
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The New York Times interviews President Obama about health care:
I’m a pretty well-educated layperson when it comes to medical care; I know how to ask good questions of my doctor. But ultimately he is the guy with the medical degree. So, if he tells me, You know what, you’ve got such-and-such, I don’t go around arguing with him or go online to see if I can find a better opinion than his.
It’s shockingly bad advice.
Numerous studies show that patients get the wrong diagnosis as much as 20% of the time, and get the wrong treatment half of the time. Thirty-five percent of doctors and 42% of patients report errors in their own care or that of a family member. Studies show that most errors happen because of a failure to analyze the patient’s problem correctly. Experts, like Dr. Jerome Groopman from Harvard, say that doctors, strapped for time and dealing with complicated problems, easily fall prey to cognitive pitfalls that create poor quality.
Ask questions, be skeptical, disrupt your doctor’s thought process. Make sure the decisions about your care are right.
Above all, remember it is you, the patient, that are in charge, not the “guy with the medical degree.”
(h/t @epatientDave via twitter)
*This blog post was originally published at See First Blog*
