Beware Decorative Contacts!

 

 

 October 30, 2012

Halloween celebrations are often a time to dress like your favorite star or a creature of the night, which means altering your appearance.  Some choose to do this by wearing decorative contact lens to make sure they fit the role.  But choosing to change the look of your eyes can sometimes come with consequences, sometimes resulting permanent damage.  The FDA has recently released a notice cautioning users of decorative lenses.

Decorative contact lenses are meant to change the look of your eye, not correct you vision.  They are sometimes called:

• Fashion contact lenses
• Halloween contact lenses
• Color contact lenses
• Cosmetic contact lenses
• Theatre contact lenses

While the names might not make it clear, these are medical devices!  The FDA oversees their regulation just like other medical devices.  Just as you would not purchase your regular contacts from anyone off the street, you should not purchase your decorative lenses from just any place.  You should not buy them at a street vendor, beauty supply store, flea market, novelty ship or Halloween store – you should see your doctor for a prescription.

Know the Risks

Just as regular contacts can cause eye problems, decorative contacts can cause problems too.  Risks include:

• A cut or scratch on the top layer of your eyeball (Corneal Abrasion)
• Allergic reactions like itchy, watery red eyes
• Decreased vision
• Infection
• Blindness

When wearing any type of contact lenses, be aware of signs of possible eye infection, which include:

• Redness
• Pain in the eye(s) that doesn't go away after a short period of time
• Decreased vision

If you have any of these signs, you need to see a licensed eye doctor (optometrist or ophthalmologist) right away! An eye infection could become serious and cause you to become blind if it is not treated.

You can avoid some of these risks by getting any type of contact lenses from your doctor. Be sure to follow the directions for cleaning, disinfecting, and wearing the lenses that your doctor gives you. If your doctor doesn't give you any directions — ask for them!

Dos and Don'ts

Do get an eye exam! A licensed eye doctor will examine your eyes to make sure the contact lenses fit properly. The fit of your contact lenses is very important. A wrong fit can cause damage to your eyes. Be sure to always go for follow-up eye exams.

Do get a prescription! Your eye doctor will write you a prescription for all contact lenses, including decorative lenses. The prescription should include the brand name, correct lens measurements and expiration date.

Do follow the contact lens care instructions! Follow the instructions for wearing, cleaning and disinfecting your contact lenses that come with your contact lenses. If you do not receive instructions, ask an eye doctor for them.

Do seek medical attention right away and remove your contact lenses if your eyes are red, have ongoing pain or discharge! Redness, pain and discharge from the eyes are signs of an eye infection. If you think you have an eye infection from your contact lenses, remove them and see an eye doctor right away.

Don't share your contact lenses with anyone else! You wouldn't share your toothbrush would you? All eyes are not the same size and shape and your contact lenses are fitted just for you.

Don't buy any contact lenses without a prescription! If you don't see an eye doctor and get a prescription, then the contact lenses you get may not fit properly and may not work well. They could even damage your eyes. Sometimes wearing contact lenses can damage the top layer of your eyeball (cornea). Even if you aren't having any problems now, the lenses still could be causing damage to your eyes. By having regular check ups and buying contact lenses with a prescription, you will reduce the chances of any undetected damage to your eyes.

Buying Decorative Contact Lenses

You can buy contact lenses, including decorative contact lenses, from an eye care doctor, on the Internet or from a mail-order company. It's very important that you only buy contact lenses from a company that sells FDA-cleared or approved contact lenses and requires you to provide a prescription.

Anyone selling you contact lenses must get your prescription and verify it with your doctor. They should request not only the prescription, but the name of your doctor and their phone number. If they don't ask for this information they are breaking federal law and could be selling you illegal contact lenses.

Remember — Buying contact lenses without a prescription is dangerous!

Right now there are a lot of products that you can buy without a prescription but they may not be safe or legal. Never buy contact lenses from a street vendor, a beauty supply store, flea market, novelty store or Halloween store.

It's your job to make sure you protect your eyes by having an eye exam, getting a prescription and buying contact lenses from a legal source.

 

Content from the FDA  - http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ContactLenses/ucm270953.htm

 

New Diet Pills Offer Option to Off-Label Obesity Drugs

By MELINDA BECK

July 30, 2012, 6:50 p.m. ET

Piper Miguelgorry started gaining weight in her 30s and 40s, after having three sons. The environmental researcher from Folsom, Calif., tried many diet regimes, without success, until she found a weight-loss center in nearby Roseville, where phentermine, a prescription appetite suppressant, was part of the plan, along with a high-protein, low-carb diet.

"Much to my surprise, I lost 50 pounds," says Mrs. Miguelgorry, 58, who has kept it off for more than a year. She also beat Type 2 diabetes and cut her cholesterol in half. She credits phentermine with helping reduce her craving for carbohydrates and plans to stay on it indefinitely.

 

Two diet pills just approved by the FDA, Qsymia and Belviq, won't be available for several months, but some doctors have been prescribing the ingredients of Qsymia (a migraine drug and phentermine, an old diet pill) to patients for years specifically for weight loss. Melinda Beck on Lunch Break explores the risks and side effects. Photo: AP.

Physicians who treat obesity hailed the Food and Drug Administration's recent approval of two new diet drugs—the first in 13 years—as a new era in weight-loss management. But some obesity specialists, including those at prestigious medical centers, have been prescribing medications to help patients lose weight for decades, both on and off-label.

Those medications include phentermine and several other stimulants approved for weight loss in the 1950s, as well as drugs to treat diabetes, depression and attention-deficit disorder that have weight-loss as a side effect.

One of the newly approved drugs, Qsymia, is a combination of phentermine and topirimax, a drug for easing seizures and migraines that also tends to make people feel full. The other, Belviq, works on brain receptors for serotonin, a neurotransmitter than triggers feelings of satisfaction.

Physicians can legally prescribe medications for uses not specifically approved by the FDA. But most obesity doctors do so cautiously given the history of diet pills removed from the market due to serious side effects including death.

"The fact that we've got two new drugs approved will reaffirm to the public that this truly is a medical problem and there's a place for pharmacotherapy," says Ed Hendricks, head of the Center for Weight Loss Management, which treated Mrs. Miguelgorry.

While some experts argue that people who are obese should simply eat less and exercise more, many physicians who treat obesity say it is driven by biological changes in the body, not lack of willpower.

"People say, 'Why are you treating a lifestyle problem with medication?' If you think that, you don't understand obesity," says Louis Aronne, director of the Comprehensive Weight Control Program at New York Presbyterian Hospital/Weill Cornell Medical College. He says there is mounting evidence that in some people, neurons in the hypothalamus that should recognize when the body has stored sufficient fat and either cut food intake or boost energy expenditure aren't working properly. Medications can help, says Dr. Aronne, who oversaw clinical trials of Qsymia.

In trials of 3,700 obese and overweight patients, those who took Qsymia for one year lost 6% to 9% more of their body weight than those on a placebo. Nearly 70% lost at least 5% of their weight.

With Belviq, of nearly 8,000 patients studied, those on the drug lost about 4% more than those on placebo. All were also counseled to exercise and eat a reduced calorie diet. The FDA says people who don't lose at least 5% of their weight in 12 weeks should discontinue the drugs.

People who eat very large portions or think about food all the time, even right after a meal, aren't getting biochemical signals to stop eating and may find drugs helpful, says Robert F. Kushner, clinical director of the Comprehensive Center on Obesity at Northwestern University.

People who eat for emotional reasons tend to benefit less, although drugs can help clarify their motivations. "If you give a medication that makes them feel full, but they still keep eating, it becomes very clear that it really is emotional," says Dr. Kushner, chairman of the American Board of Obesity Medicine.

The new drugs are FDA approved for patients with a body mass index of 30 or higher, or with a BMI of 27 and high blood pressure, diabetes, high cholesterol or sleep apnea. People with very large amounts of weight to lose may benefit more from bariatric surgery, or a combination, doctors say. The drugs aren't covered by most insurance companies. They are expected to be available this fall.

Most of the drugs currently prescribed for weight loss suppress appetite by affecting neurotransmitters, which send signals in the brain. Stimulant medications are among the most powerful. The FDA approved several stimulants—including phendimetrazine (marketed as Bontril) and diethylpropion (Tenuate)—specifically for weight loss in 1959. They remain on the market today.

How They Work

Drugs sometimes prescribed for weight loss work in various ways.

·         Stimulants rev up the central nervous system.

·         Antidepressant drugs such as buproprion (Wellbutrin) affect brain chemistry.

·         The diabetes drug metformin (Glucophage) reduces the impact of blood sugar. Liraglutide (Victoza) boosts a gut hormone to promote fullness.

·         The FDA-approved obesity drug orlistat (Xenical, Alli) blocks fat absorption.

·         Naltrexone (Depade, ReVia) blocks opiod receptors and makes food less appealing.

The best known is phentermine, half of the popular fen-phen combination in the 1990s until fenfluramine was linked to heart-value damage and discontinued in 1997. Because they are potentially addictive, phentermine and the others are approved for short-term use only. "But all of us use it long-term," says Dr. Kushner. Dr. Hendricks, who says he has treated 15,000 patients with phentermine, alone and in combinations, over 23 years, and says that patients who keep taking it tend to maintain their weight loss. Drs. Aronne, Hendricks and Kushner all consult for drug makers.

ADHD drugs including Ritalin and Adderall also suppress appetite in some patients, but most obesity doctors use older generic stimulants. Patients with heart disease, high blood pressure, hyperthyroidism or glaucoma should not use stimulants.

The diabetes drug Metformin helps decrease the amount of sugar the body absorbs from food and increases the body's response to insulin. Some patients can experience dangerously low blood sugar.

It is unclear why bupropion (Wellbutrin) doesn't make patients gain weight the way other antidepressants do, but it may help ease cravings. (Last month, GlaxoSmithKlein agreed to pay a $3 billion fine in part for promoting Wellbutrin for weight-loss and other off-label uses.)

Naltrexone (Depade, ReVia) helps alcoholics stop drinking by blocking opiod receptors in the brain, diminishing the kick booze provides. It may make food less rewarding the same way. Side effects, in rare cases, may include liver damage.

Some clinics promote human chorionic gonadotropin (hCG), an infertility treatment, as a way to "reset metabolism" when combined with a 500-calorie-a-day diet. But obesity experts say there is no evidence that hCG works better than a placebo. The FDA has warned seven companies to stop selling over-the-counter hCG and making unsupported claims.

Respected obesity experts say consumers should be wary of purported diet drugs sold over the Internet, as well as doctors who sell drugs from their offices, with little or no evaluation or without a comprehensive weight-loss plan.

Diet Drugs Over the Years

Medications the FDA approved, rejected or the makers withdrew

Years on the U.S. Market	Drug (Brand Name)	Comment
1949-1979	Amphetamine	Discontinued due to potential for abuse
1959-present	Phentermine and other anoretics	Appetite suppressants; approved for short-term use only
1960s	'Rainbow pills'	Amphetamine, digitalis, diuretics combined; discontinued after links to several deaths
1973-1997	Fenfluramine (Pondimin)	Often combined with phentermine in 'fen-phen'; withdrawn after links to heart value problems
1996-1997	Dexfenfluramine (Redux)	Similar to fenfluramine; withdrawn after links to heart value problems
1997-2010	Sibutramine (Merida)	Withdrawn due to risk of heart attack, stroke
1999-present	Orlistat (Xenical, Alli)	Blocks fat absorption
2007 (rejected)	Rimonabant (Acomplia)	Suspected link to suicidal thoughts
2011 (rejected)	Contrave	Combines an antidepressant and an alcoholism drug; now undergoing more trials
2012	Qsymia, Belviq	Approved after additional data submitted

A version of this article appeared July 31, 2012, on page D1 in the U.S. edition of The Wall Street Journal, with the headline: New Diet Pills Offer Option To Off-Label Obesity Drugs.

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