March 2, 2011 — The FDA today announced steps to remove more than 500 prescription cold, cough, and allergy products from the market because of potential safety concerns.

The FDA asked companies to stop manufacturing the 500 products within 90 days and stop shipping them within 180 days. Some manufacturers must stop making and shipping their products immediately, the FDA warns.

Here is the list of banned products.

The FDA does not know if these prescription drugs are safe or not largely because they were grandfathered in before changes to the FDA’s drug approval process were enacted.

“We don’t know what they are, whether they work properly, or how they are made,” said Deborah M. Autor, director of the FDA’s Office of Compliance at the Center for Drug Evaluation and Research (CDER) in Silver Spring, Md., during a teleconference. “The problem is that we don’t know what the problem is.”

For example, some of these cough, cold, and allergy drugs are labeled as “time-release.” These are complicated to manufacture, and the FDA has not reviewed whether the active ingredient is released in a consistent matter over a period of time, she says. “They may be released too slowly, too quickly, or not at all.”

Others contain an “irrational” combination of the same types of products, such as two or more antihistamines, and some are inappropriately labeled for use by infants and young children, she says. Many contain the same ingredients as the over-the-counter cough and cold products that are no longer supposed to be used in kids under 2.

Yolandra Hancock, MD, a pediatrician at Children’s National Medical Center in Washington, D.C., praises the FDA’s move.

“The new FDA decision supports modern-day pediatric practice to avoid cough syrups in children under 2 because they do more harm than good,” she says. Some may slow down breathing, and others decrease cough and allow mucus to sit in the chest, where it can cause other problems such as lung infection, she says.

“I fully support the FDA’s move in controlling access to these medications in children; it is highly appropriate and long overdue,” she says.

As to the risks these drugs pose, “for the most part, [these adverse reactions] are not serious,” says Charles E. Lee, MD, medical officer of the division of new drugs and labeling compliance at the CDER.

After the FDA crackdown on the use of over-the-counter cough and cold medicine in children younger than 2, the number of emergency room visits for adverse events decreased by 50%, he says.

To find out whether a medication you are using is FDA-approved, click this link, and enter the name of the medication in the search box. If it shows up, it is FDA approved, and is safe to use as directed.

An FDA flyer for consumers about this action can be viewed here.

Want to do something that helps TWO great organizations at the same time AND makes you feel good?

I just learned about the Girl Scouts’ Program called “The Gift of Caring”, from a friend’s daughter, an 11 year-old Girl Scout.

Here’s how it works: Instead of buying Girl Scout cookies for yourself, you can request that your purchase be used to send cookies to military personnel serving overseas. Imagine an American soldier in Afghanistan opening up a care package, and getting a little taste of the U.S.A., courtesy of you and the Girl Scouts.

I thought this was a wonderful idea – and so I’ve donated in this way. I hope that some of you will do the same. If you would like contact information for the Girl Scout troop I supported, please contact us at the office.

Besides, it keeps me from eating those yummy cookies!!

With the holiday travel season fast approaching, I’ve been thinking a bit about TSA’s X-ray scanner. I’m all for effective security measures, but I’m not a fan of the travellers dilemma: TSA pat-down / assault versus the who-knows-whether-it’s-really safe X-ray scanner run by non-medical people who have no idea what they’re using.

Surfing the net, I found the perfect answer to express my frustration. It’s a T-shirt, with the U.S. Constitution’s fourth amendment on it – the one prohibiting unwarranted searches – but it’s written in metallic ink.

It’s a normal looking T-shirt, but when you go thru the TSA X-ray machine, the printed message on the shirt lights up like a Christmas tree on the TSA’s computer view-screen.

The company also makes boxer shorts with the same message!

Bad news for those of you hoping to reduce their cancer risk by eating a diet rich in fruits and vegetables: it doesn’t seem to work. The results of a decade-long epidemiologic study in the British Journal of Cancer (link) seem to suggest there is no protective effect between fruit and vegetable consumption and several of the most common cancers- such as lung, breast, colorectal or prostate cancer.Initial studies in the 1990s appeared to show that those with a low intake of fruit and vegetables were at greater risk of developing cancer. More specific follow-up studies, however, have concluded that larger intakes of fruit and vegetables do not offer greater protection.

This study, from Oxford University, recommends that we should continue to include “at least a moderate amount of fruits and vegetables” based on basic nutritional principles, but that increasing this level would not have much effect on cancer rates. Instead, the study’s author suggests that we need to really look at the adverse effects of obesity and high alcohol consumption rates.

However, my vegan friends need not despair: in a separate study, the incidence of coronary heart disease or stroke was 30% lower for those consuming five or more servings per day compared with those eating less than 1.5 servings of fruits and vegetables per day.

So once again, mom was right: an apple a day is a good thing. It just doesn’t prevent cancer.

I’ll be away for a few days, attending the ASPS meeting in Toronto, so I’ll be taking a little break from blogging….but when I come back, I promise to share the latest info on:
– fat grafting
– new fillers
– laser updates
– new variations on surgical procedures
and new trends in plastic surgery.In the meantime, don’t hesitate to visit the office and take advantage of our best-ever October specials on skincare products and injectable fillers!

According to an article published online in BusinessWeek, the hand washing habit is finally catching on after years of public health promotional activities.

As you might expect, women are better about this then men are.

Researchers observed 6,028 adults in public restrooms in 4 major cities in August 2010 and found that 85 percent of people washed their hands, compared with just 77 percent in 2007.

Among women, 93 percent are hand-washers. Among men, only 77 percent.

For best results, the U.S. Centers for Disease Control and Prevention (CDC) recommends that: people use soap and warm water, rub their hands together for at least 20 seconds and, if possible, to use a paper towel to turn off the faucet. An easy way to teach a child the 20 second rule – it’s approximately the time it takes to sing “Happy Birthday” twice.

See – Mom was right again!

Background: For the last few years, cardiologists have been following a blood test called homocysteine, as a risk indicator for heart and stroke. Previous studies have showed an association between lower homocysteine levels and lower coronary heart disease. However, no studies have yet been able to prove a benefit (i.e. less heart disease) from interventions which lower homocysteine.

This week, in JAMA, the latest study on this topic was published. It was a double-blinded, randomized, placebo-controlled trial (the best kind) of 12,000+ people who had previously survived a heart attack. They were given vitamin b12 and folate supplements, which are known reduce homocysteine levels by about 30%. During the 6.7 years of follow up, it was found that even though the blood levels of homocysteine were lowered by about 28%, there were no apparent beneficial effects on major coronary events or other non-coronary vascular events. The vitamin supplements didn’t cause any harm, though, with no changes in mortality or the appearance of other cancers.

Sadly, the vitamins didn’t help. The homocysteine molecule itself doesn’t seem to have a direct effect on the heart.

What does this mean? We have to focus on what actually has been proven to work when it comes to risk reduction for heart disease: lifestyle changes (like avoiding excessive weight gain and quitting smoking), controlling blood pressure and cholesterol, and so on. Vitamin B12 and folate supplements, unfortunately, are not the magic bullets.

It’s controversial, but some new studies suggest there may be people who have addictive behavior patterns when it comes to tanning and the use of UV tanning beds.

A recent study published in Archives of Dermatology, by researchers at Memorial Sloan-Kettering Cancer Center and the University of Albany, found that 27 percent of college students surveyed have a psychological dependence on tanning in UV-light beds and booths.

The researchers suggested that the “tanning addiction” includes symptoms that are really quite similar to those that alcoholics or smokers experience, such as tanning with ever-increasing frequency, having withdrawal issues, or trouble stopping the habit.

The college students who were addicted to indoor tanning were also more likely to have symptoms of anxiety and/or greater use of alcohol, marijuana, and other substances, than their peers who were not addicted to indoor tanning.

Tanorexia: now it’s a recognized disease syndrome. Who knew?

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