Is it a New or Old Weight Loss Drug?

This month I am talking about obesity & weight loss. By our human (and American) nature, we would all like a quick fix to solve our weight issues. This summer, the FDA approved not one, but TWO new weight loss drugs.  My last blog addressed lorcaserin (Belviq), and today's focus is really something old in a new package.

Qsymia was FDA approved in July 2012, and it is a combination of two older drugs that have been used independently to help with weight loss: phentermine and topiramate. Phentermine is an appetite suppressant, and was half of the infamous fen-fen (a diet pill combo that was removed from the market once its use was associated with the development of pulmonary hypertension (a damaging condition in the lungs) and heart valve issues. Phentermine by itself is still approved for "short term" use- a few weeks- as an appetite suppressant, but there is limited efficacy and safety data available. Topiramate was originally classified as an anti-seizure medication, but indications now also include migraine prevention. Physicians and patients were generally pleased to see that a side effect of topiramate is weight loss (to the point where I have had patients without frequent migraines ask if I will prescribe this drug "just in case"!)

Qsymia combines these two drugs, and showed significant weight loss at one year- an average of 8.9%.
Both drug components are  at much lower doses than the individual drugs are typically prescribed, which hopefully will limit side effects. Indications for this new drug are for patients who have a BMI>30 (defined as obese) OR if they are overweight (BMI>27) AND have high blood pressure, diabetes, or high cholesterol.

If you meet those qualifications and are interested in trying this new drug, don't rush to your doctor quite yet! Qsymia is not yet in pharmacies, though it is anticipated to be in "certified pharmacies" next month (September 2012).

BOTTOM LINE: The newly approved weight loss medication, Qsymia, combines two older medications and may prove to be significantly effective in helping treat obesity, but it is not available quite yet. 

A New Weight Loss Drug!

Have you heard that the FDA approved not one, but TWO new weight loss drugs this summer? Hooray! Our problems are solved, right? Are there still overweight doctors out there? Well...yes, there are, so that should give you a clue that these new drugs are not miracle workers.

Today I will focus on the first drug approved. Locaserin, brand name Belviq, came out in June 2012. This drug will decrease your hunger and increase your feelings of satiety (feeling full after a meal). Locaserin works within the serotonin system (like the antidepressants such as Prozac) but targets a specific receptor that is key in the appetite game, rather than mood. Fenfluramine, an older drug with a similar mode of action, was removed from the market in 1997 due to concerns of its detrimental affect on heart valves. The selling point of locaserin is that it targets a different, very specific receptor that is not linked to these deleterious valve changes.

In the studies necessary to get approved by the FDA, patients on this drug lost an average of 12 pounds in one year. Let me remind you that good steady weight loss is a pound or two per month (not the 30 pounds in 30 days we all would like), so this is reasonable weight loss. However, from my standpoint, I'd like to see a drug produce better results before risking the side effects. In this case,  side effects of lorcaserin include headache, dizziness & nausea. So at this point, I am not impressed enough to prescribe this drug.

BOTTOM LINE: Lorcaserin (Belviq) may provide obese patients help with decreasing their appetite & increasing satiety, but does not provide dramatic weight loss results.

Shingles Vaccine- Starts Now at Age 50

Shingles, also known as Zoster, or Varicella Zoster, is a delayed eruption from the Chicken Pox virus. The chicken pox virus is in the herpes family of viruses, all of which stay in your body after the initial infection, and then show up later along a nerve pathway. In the case of shingles, the secondary eruption typically only happens once (versus herpes simplex that can cause many recurrences for years.) Roughly 10-20% of the population will develop shingles at some point in their lifetime.

What does it look like? Shingles is a very localized rash that occurs in a band pattern that wraps around one side of your body, most often the face, back or chest. The rash is made of clusters of red bumps that turn into blisters, then scab over. There is often tingling, stinging or burning pain in the affected area, starting before the rash even appears. The pain can range from mild to severe, and unfortunately, the pain can persist long after the rash has resolved in roughly 15% of patients- this is called Post-Herpetic Neuralgia (PHN.) The good news is that early initiation of anti-viral medication can not only shorten the duration and severity of infection but also decreases your chance of developing PHN.

Additionally, we have a shingles vaccine available, and the FDA has lowered the age of recipients from 60 to 50. A study of 22,000 patients between the ages of 50-59 showed that receiving the vaccine reduced their chance of having shingles by 70%. Although the FDA has APPROVED it for use starting at 50, I should note that our current guidelines from the ACIP (Advisory Committee on Immunization Practices) still recommends the vaccine be given starting at age 60, so please discuss this with your family doctor.

BOTTOM LINE: Consider adding a Shingles Vaccine to your your health prevention list when you turn 50!

Simvistatin (Zocor) Warning!

Are you one of over 2 MILLION Americans who are taking Simvistatin (Zocor) 80mg to lower your cholesterol? The FDA has issued a safety announcement regarding the highest recommended dose of simvistatin, trade name Zocor. The bottom line is that the 80mg dose, has been found to have an unacceptable rate of muscle damage, especially in the first year of use. The FDA no longer recommends STARTING patients on this high dose, even those patients who are tolerating the next highest dose (40mg) but need still better improvement in their cholesterol panel. If you have been on simvistatin for more than a year and you are doing well- low "bad" cholesterol numbers and no unexplained muscle aches- then you are exempt from this rule, and may continue taking the drug at this dose (but I'd suggest you have a conversation with your doctor at your next check up.)

In the last several years, we have switched many patients to simvistatin, because frankly, it became generic and was much less expensive than its name-brand counterparts. Doses are not equal among statins- they are apples and oranges. When you switch, for example, from Rosuvastatin (Crestor) to simvistatin (whether it's name brand Zocor or generic), you will need a much higher dose of simvistatin to achieve the same effects.

The cardiology gurus push us to get those cholesterol levels lower and lower to optimally reduce risk of heart attacks and strokes. In response, we push the dose of our cholesterol lowering medications higher and higher, which obviously increases the rates of side effects. In the case of statins, the most serious side effect comes when there is muscle breakdown (myopathy) so severe that it effectively clogs up the kidneys and can throw them into frank kidney failure. This potentially fatal process is called rhabdomyolysis, "rhabdomyo" meaning skeletal muscle, and "lysis" meaning breakdown. Rhabdomyolysis is a rare dangerous side effect of ALL statins- roughly 4-5 people out of 100,000 on these drugs will be hospitalized from this problem. Unfortunately, the 80mg dose of simvistatin carries the highest risk.

Statins help reduce heart attacks and strokes, but make sure you have optimized your diet and exercise so you can be on the lowest dose that your genetics allow. My pet peeve is seeing people blame medications for bad outcomes, when behavior modification might have prevented that person from ever NEEDING the drug to begin with!

BOTTOM LINE: If you are on a statin, especially simvistatin (ZOCOR), be aware of the warning signs of dangerous side effects (unexplained tender muscles), and take ownership of your part of the cardiovascular risks of high cholesterol by eating MORE fruits and vegetables and exercising daily!

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FDA's New Cigarette Labels- Wonderfully GROSS!

Let's hear it for the FDA! Cigarette boxes will no longer carry the simple boxed warning that smokers have come to ignore over the last couple decades. Instead of these simple printed words, now there will be nine different graphic images with accompanying appropriate messages. "WARNING: Smoking is addictive"- showing a man smoking from the hole in his tracheotomy (a hole in the neck surgically created for patients on ventilators long term), or "WARNING: Cigarettes cause fatal lung disease" with a picture of healthy pink lungs next to horribly diseased lungs. I think my favorite, though, is the one I posted above, with the yellowed teeth and cancer sore rotting on the lip.

I believe we need to address tobacco addiction at the age and interest level of the smoker. Teens rightly aren't terribly concerned with emphysema at age 60, nor lung cancers even as early as their 40s. They MIGHT listen, however, to concerns about bad breath and yellow teeth. An older smoker, however, may believe tooth whiteners and listerine will fix any transient problems, but the threat of stroke or heart attack from tobacco-related disease might hit home.

Whatever the age, I am pleased to see new marketing strategies put in place to shake up the routine. The FDA will be rotating pictures/messages to be sure that smokers are barraged with new warnings as they begin to be desensitized to the first batch.
Smoking is VERY addictive, and I have yet to meet a smoker over the age of 30 who doesn't wish they had never picked up that first cigarette- even those who steadfastly maintain they enjoy smoking and "don't care if it kills (them)".

BOTTOM LINE: If you still smoke, PLEASE talk to your doctor and find out what options you have to help you QUIT for LIFE.

Sunscreen Labeling Update from the FDA

Hooray! The FDA issued a press release this week that will only allow sunscreen products that protect against BOTH UVA & UVB rays to be labeled as "Broad Spectrum" and they must have SPF values of 15 or higher to state that they reduce the risk of skin cancer and early aging. Previously, SPF only addressed UVB rays, which are the primary cause of sunburn. Both UVA & UVB cause skin damage and skin cancers.

Earlier this month, I blogged about "which sunscreen is best", but let me review a couple key issues. SPF- Sun Protection Factor- measures the amount of solar energy required to cause a sunburn on protected skin versus unprotected skin. While in general terms that means a sunscreen with an SPF of 30 should allow you to be in the sun for 30 times the sun exposure before causing damage, realize there are two major qualifying factors. One, the UV radiation is more intense at different times in the day. Fifteen minutes at noon may equal an hour early in the morning. Two, no sunscreen- even when applied correctly- stays fully effective more than a couple hours. What's correct application? A full OUNCE per person, applied thoroughly and reapplied every two hours. Of course, altitude, latitude, cloud coverage and skin type all factor into the degree of solar intensity required to cause damage as well. With this in mind, the FDA is additionally proposing to limit the maximum SFP to "50+" as there is no evidence to show that products with SPF's higher than 50 provide any additional protection beyond those labeled as 50.

What does all this mean for the average consumer? For now, keep reading sunscreen labels more closely, making sure that the product you are choosing protects against BOTH UVA and UVB radiation. Typically, if you look at the active ingredients and see zinc or titanium dioxide along with several other chemicals, you've got the right product. The new labeling wont be obvious on the shelves till next summer, so while this announcement is a step in the right direction, don't assume products labeled "broad spectrum" this year are truly that. Also, please don't forget about hats and protective clothing, especially if you are going to have extended time outdoors.

BOTTOM LINE: Double check your sunscreen to be sure you are protecting your skin from BOTH types of UV radiation- UVA & UVB- because they BOTH cause skin damage that can lead to skin cancers.

Where Did My Favorite Cold Medicine Go?

Today the FDA (US Food & Drug Administration) is removing many allergy, cough and cold products from the shelves of your pharmacy. If you have a favorite that has worked for you, perhaps you should stock up. What's going on? Well, it turns out that there are a ton of drugs out there that lack FDA approval, yet doctors and patients alike are unaware.

Why does it matter? Our FDA actually does a great job of collecting and reacting to adverse events related to medications, acting swiftly to remove products that could cause danger. Though there are not oodles of reports with this group of products, there are enough, especially considering that because most are over-the-counter, adverse events are much less likely to be reported.


Frankly, as I went through the list, I was very surprised that some drugs that I have previously written prescriptions for (like Entex PSE and Bromfed) are NOT FDA approved. The main reason I don't routinely recommend herbal treatments is their lack of FDA regulation, which means there is no guarantee of the amount of ACTIVE product in each tablet or capsule. Turns out, this could be true for any of these allergy, cough & cold remedies as well. Additionally, in the past couple of years, pediatric recommendations have changed greatly, especially for kids younger than two years. Many of these medications do not issue any such precautions.

Here are a few, but go to the FDA website for a full list: Accuhist DM, Aerohist, Allerx, Aquatab, Bromfed, Biotuss, Brovex, Carbodex, Deconamine, Duravent, Entex, Guaifenesin, Histex, Lodrane, Rescon, Ru Tuss, ZCof, etc.

Note that the Triamic brand and Robitussin brand are NOT on the list.

BOTTOM LINE: Go to the FDA WEBSITE and scan the list to be sure YOUR upper respiratory medicine of choice is NOT on the list!

FDA Warning: Cough Medication DANGER!

Yesterday the FDA issued a warning regarding a medication that has frankly NEVER been on my radar as a dangerous drug- Tessalon (benzonatate). Sadly, there have been five deaths reported in children under the age of 2 after accidental ingestion of this medication, which is a gel capsule and looks like candy or a bath bead.

Is the medication safe for adults? Yes. Tessalon perles are indicated for cough suppression in patients over the age of 10. In my practice, I have found that the drug has a high variability in effectiveness, but rarely has any side effects. Many patients love this drug because it works well to suppress their cough without making them feel goofy or sedated, like the stronger narcotic cough syrups tend to do.

I think the real take home message here is that ALL medications, ESPECIALLY those that "look pretty", need to be in CHILD-PROOF containers AND put away out of reach from little hands. There are far more accidental poisonings from common over the counter medications and vitamins, and ALL PILLS should be stored behind locked cabinets when you've got children in your home (living there or visiting!)

BOTTOM LINE: Please have a special, truly CHILD-PROOF medicine storage area in your home, and realize kids always have and always will stick things in their mouths without thinking!

Heartburn or Broken Bones?

Okay, I'm interrupting my summer tips with this "breaking" report. The FDA has issued a warning regarding proton-pump inhibitors (PPI's) which are medicines that stop acid production such as Prilosec, Nexium, Prevacid, etc. Six of seven studies showed that people, especially those over 50, who take these medications- whether they are the over the counter version or prescribed- for over a year or in high doses, have increased risk of fractures in their hips, spines, and/or wrists.

So what does this mean? Do you have to choose heartburn or broken bones?

Of course not. What it means is that these drugs, like every other class, have potential side effects. We need to use them judiciously, and not as a band-aid for a long term problem. GERD is typically caused by behaviors that can be modified: caffeine, alcohol, and nicotine are at the top of the list. Consider switching gradually to decaf, decreasing your alcohol intake, and quitting smoking instead of routinely grabbing your acid pill every day.

BOTTOM LINE: All medications have side effects; please review ALL of your medications with your doctor and see which, if any, can be reduced or eliminated if you are willing to make some behavioral changes.