In early September, the Food and Drug Administration said it would release its first list of 20 drugs that are being investigated for possible side effects. The agency’s new policy of regular quarterly releases of drugs under investigation is the result of 2007 mandatory congressional legislation. There are potential pros as well as cons:

Pros:
* Public awareness may grow about drugs that are commonly misused. Oxycontin, a narcotic with a very high potential for overdose and addiction, was listed as being under investigation.
* The FDA is being held to a higher standard of disclosure, and this way the public can track its thinking and investigative processes rather than just being shocked by news reports of unpredicted black box warnings.
* Physicians may be more cautious to prescribe new treatments without considering potential side effects.

Cons:
* Patients may abruptly stop treatments that are working without checking with their physicians.
* The lists are cursory – they don’t include all drugs under investigation or complete information of the drugs being investigated. Statistics on deaths, hospitalizations,  or even numbers of reported side effects are not included.
* Knowing that a drug is being reviewed may create fear, and a public perception that is out of proportion to the actual risk. Tysabri is a very effective drug for the treatment of Multiple Sclerosis that is now being investigated for association with skin cancer. Cymbalta is a powerful anti-depressant that is being investigated for urinary complications. Public awareness of these ongoing investigations may severely limit patient willingness to take very effective treatments.

Suspicion of prescription drugs is the prevailing trend, despite the fact that many of these treatments are lifesaving. A case in point is Byetta, a diabetes drug that has been on the market since 2005 with close to a million patients benefitting from its biochemistry. Byetta is an incretin mimetic, which means it is a synthetic hormone which stimulates insuin secretion in response to meals. Not only is this often a smart treatment, and a good arrow to add to the medical quiver, but it also can cause weight loss, which in itself can help to improve glucose control in diabetics.   

But news reports of a rare death from pancreatitis (the rate of pancreatitis associated with Byetta is only one in 10,000 cases, and has not been proven as due to the Byetta) has led to public fears of the drug. The drugmaker, Amylin, has seen its stock drop 43 percent in the month since the FDA announced that it was considering a stern warning in response to the potential risk of pancreatitis.  

Warnings can be helpful. But fear of essential treatments can also be harmful.

Dr. Marc Siegel is an internist and associate professor of medicine at the NYU School of Medicine. He is a FOX News Medical Contributor and writes a health column for LA Times, where he examines TV and movies for medical accuracy. Dr. Siegel is the author of “False Alarm: the Truth About the Epidemic of Fear” and “Bird Flu: Everything You Need to Know About the Next Pandemic”. Read more at www.doctorsiegel.com

Questions always arise as to what is the newest and greatest filler and whether it is possible with these new fillers to erase the lines of time.  Evolence is a new porcine or pig-based collagen that has been recently released by the Food and Drug Administration.  It has been researched initially in Europe and Israel and is now available throughout the world, including the United States. 

            It is derived from a pig or porcine source, which is felt to have very, very low allergic potential and is new and exciting because it has unique characteristics that separate it from other fillers available on the market.  Studies in the United States show that it has comparable longevity to the hyaluronic acid derivatives such as Restylane and Juvederm lasting six months.  However, studies in Europe have suggested that this filler may have longevity up to 12 months.   The reason this product lasts somewhat longer than the hyaluronic acid derivatives is felt to be secondary to its unique way of linking the strands of the collagen molecule together.  It has a very unique patented technology called Glycomatrix™, which is responsible for the unique structural characteristics and longevity noted with this new and unique filler.    It also has excellent flow characteristics, which again give it a very smooth and natural appearance and also gives the face excellent structural integrity.

            The question comes up as to who is the best candidate to use this unique filler.  Anyone with deep folds on the face, along the cheek folds or along the marionette lines or for fine lines on the upper or lower lip or for localized volume replacement on the face, would be appropriate candidates for using this new and unique filler product.

            Its safety has been shown to be remarkable in multiple studies and requires no skin testing.  A second generation filler called Evolence Breeze is now under investigation, which can be used for shaping and molding the lip naturally.  We have yet another exciting new filler with unique characteristics.  Evolence is truly the rebirth of the collagen molecule.

Dr. Neil Sadick is one of the most renowned dermatologists and researchers whose multiple discoveries have strongly influenced and transformed the future of dermatology. He is a Professor of Dermatology at Weill Cornell Medical College and President of the Cosmetic Surgery Foundation. Dr. Sadick is author, or co-author, of more than 500 articles in peer-reviewed scientific journals and has contributed more than 75 chapters of medical books. Read more at www.sadickdermatology.com

Alert: FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now

The U.S. Food and Drug Administration is encouraging asthma patients to speak with their physicians and health care providers about the “switch” to HFA-propelled rescue inhalers (albuterol).  These environmentally friendly inhalers will replace the old CFC propelled inhalers that are harmful to the ozone layer. 

The FDA is encouraging patients to talk to their health care providers now about switching to HFA-propelled inhalers.  The new inhaler may give some patients a perception of a softer mist as compared to the old CFC inhalers.  The medication (albuterol) is exactly the same, and has not changed. 

The phase-out of CFC-propelled inhalers is the result of an international environmental treaty: the Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. FDA mandated these inhalers been phased out by the end of 2008.

Again, many patients have already been transitioned to the new propellant in their rescue inhalers and may not have even noticed the change. Talk with your provider or asthma specialist to learn more about asthma triggers and optimal control.

Dr. Clifford W. Bassett is an assistant clinical professor of medicine at the Long Island College Hospital and on the faculty of NYU School of Medicine.  He is the current vice chair for public education committee of the American Academy of Allergy, Asthma and Immunology.  No information in this blog is intended as medical advice to any reader or intended to diagnose or treat any medical condition.

The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Internet.

The agency has sent 25 warning letters to companies and individuals marketing these products, FDA officials said Tuesday. Twenty-three of the letters went to domestic companies and two to foreign individuals.

Dr. Fulbright
I’ve heard of things like horny goat weed, and some drink in the grocery store a few years back called Niagara, the female “viagra.”  Which herbal meds are safe and effective and which are not?
Stacy

Dear Stacy,
There are lots of aphrodisiacs out there – or at least supposed ones – and most of them have not been studied. So people don’t really know what they’re getting as far as quality, as well as if the suggested dosage is correct and if the product is truly safe. To date, the Food & Drug Administration (or FDA) has yet to give its stamp of approval on any of them. They don’t regulate herbal medications because they don’t have to.

That said, there are a few herbal medications out there that are supposedly good as far as sexual functioning and sexual arousal go. The more common ones are cayenne, gingko, or ginger. Once again, you’re using these at your own risk. So be sure to consult with your physician before taking any of these herbal medicines for better sex. There are types that can affect any prescriptions that you’re taking and that can harm your health more than anything. So be safe!

Dr. Yvonne Kristín Fulbright is a sex educator, relationship expert, columnist and founder of Sexuality Source Inc. She is the author of several books including, “Touch Me There! A Hands-On Guide to Your Orgasmic Hot Spots.”

The ozone layer shields the planet from harmful ultraviolet radiation.

A consumer advocacy group petitioned the government Thursday to pull the birth-control patch off the market, calling it far riskier than the pill.

“Ortho-Evra is a poor choice for women,” Dr. Sidney Wolfe of Public Citizen wrote the Food and Drug Administration.

Warnings about the Ortho-Evra weekly patch have escalated since a 2005 investigation by The Associated Press found patch users suffer higher rates of life-threatening blood clots than women who take birth-control pills.

Click here to read the full report

Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths, a review by federal regulators finds.

Parents should be vigilant in watching their children’s use of the pumps, researchers from the Food and Drug Administration wrote. They didn’t advise against using the devices. But they called for more study to address safety concerns in teens and even younger children who use the popular pumps.

Click here to read the full report

A decade after Lasik surgery hit the market the FDA is opening the floor to comments from unhappy patients. 

About 7.6 million Americans have undergone some form of laser vision correction, including the $2000-per-eye Lasik. Lasik is quick and, if no problems occur, painless.  But an unlucky few have suffered life-changing side effects like lost vision, dry eye and night vision problems. 

Do you have a story about Lasik eye surgery?  Please share your comments below. 

The Food and Drug Administration is investigating a link between the asthma drug Singulair and suicidal behavior, according to a news release Thursday.

The FDA has requested Singulair’s manufacturer Merck & Co. evaluate the drug’s data for more information about suicidality and mood changes, according to the news release.

The agency is also reviewing the post-marketing reports of patients who have reported such behavior after taking the drug.