The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.

Specifically, this includes men 50 years of age and older and women 60 years of age and older who have an elevated amount of a substance known as high sensitivity C-reactive protein in their blood and at least one additional traditional cardiovascular risk factor such as smoking, high blood pressure, a family history of premature heart disease, or low amounts of high-density lipoprotein or HDL cholesterol, the so-called “good cholesterol.”

This new indication does not support the use of Crestor in individuals who have an elevated high sensitivity C-reactive protein but no traditional cardiovascular risk factors.

Crestor is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. High amounts of low-density lipoprotein or LDL cholesterol, the so-called “bad cholesterol,” is a known risk factor for heart attacks, strokes, and heart disease.

“This expanded indication for Crestor will provide health care providers with a new therapeutic option to help appropriately-identified people lower their risk for a cardiac event,” said Eric Colman M.D., deputy director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

The new indication was based on results from a study called the JUPITER trial, which compared 8,901 patients who received Crestor for two years to the same number of patients who received a placebo. Patients who took Crestor experienced fewer cardiac events, including heart attacks and strokes, and underwent fewer procedures such as coronary angioplasty or coronary artery bypass surgery to treat or revascularize their arteries.

High sensitivity C-reactive protein is a nonspecific indicator of inflammation, which is associated with the buildup of cholesterol and other fatty material in the coronary arteries.

Crestor is already approved for use in combination with diet and exercise to lower LDL cholesterol and a related substance known as triglycerides in patients with a high amount of these substances in their blood. The medication is also approved to slow the progression of atherosclerosis – a thickening of the artery wall due to the buildup of cholesterol and other fatty materials.

Source: U.S. Food and Drug Administration

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Xiaflex is a biologic drug made from the protein product of a living organism. It works by breaking down the excessive buildup of collagen in the hand.

“Before the FDA approved Xiaflex, the only effective treatment for this hand disorder was surgery, which sometimes meant a long recovery and the need for physical therapy for patients. Since there are no other non-surgical alternatives for Dupuytren’s contracture, Xiaflex will be an important advance in the management of this disabling condition,” said Bob Rappaport, M.D., director, Division of Anesthesiology, Analgesia, and Rheumatology of the FDA’s Center for Drug Evaluation and Research.

Xiaflex is injected directly into the collagen cord of the hand and should be administered only by a health care professional experienced with injections of the hand, because tendon ruptures may occur.

The most common adverse reactions in patients treated with Xiaflex were fluid build up, swelling, bleeding, and pain in the injected area. Although no serious allergic reactions have been observed, such a response would not be unexpected because this foreign protein could prompt an immune system reaction.

In one 66-patient study, 44 percent of those injected with Xiaflex were treated successfully, compared to 5 percent for patients who received a placebo. In a separate 306-patient study, 64 percent of patients given Xiaflex were treated successfully, compared to only 7 percent of patients receiving the placebo.

Xiaflex is manufactured by Auxilium Pharmaceuticals Inc., a specialty biopharmaceutical company based in Malvern, Penn.

Source: FDA

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The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.

“The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day,” said FDA Commissioner Margaret A. Hamburg, M.D. “This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects the FDA’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. Funding in the FY 2011 request also supports new regulatory authority to regulate cigarettes and other tobacco products received in June 2009.

The proposed budget includes support for the FDA’s investment in addressing the challenges of the 21st century. The FDA envisions a transformed U.S. food safety system that focuses on prevention, increased efforts to address medical product safety challenges and a focus on modernizing regulatory science at the FDA.

These four initiatives are the major highlights for the FY2011 budget increases.

* Transforming Food Safety (+ $318.3 million)
The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

* Protecting Patients (+ $100.8 million)
The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

* Advancing Regulatory Science (+ $25.0 million)
Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the  FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

* Tobacco (+ $215.0 million)
An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

Source: FDA

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The thyroid is a 2-inch-long, butterfly-shaped gland in the front of your neck weighing less than an ounce. It’s one of the glands that make up your endocrine system. These glands produce, store and release hormones that travel through the bloodstream and direct the activity of the body’s cells.

Thyroid hormones regulate metabolism—the way the body uses energy—and affect nearly every organ in the body. They influence brain development, breathing, heart and nervous system functions, body temperature, muscle strength, skin dryness, menstrual cycles, weight and cholesterol levels.

When the thyroid gland produces more thyroid hormone than the body needs, it can cause many of the body’s functions to speed up. This problem is called hyperthyroidism. Too little thyroid hormone, called hypothyroidism, causes many of the body’s functions to slow down.

The symptoms of thyroid disease can vary from person to person. Common symptoms of hyperthyroidism are nervousness, irritability, fatigue, muscle weakness, trouble sleeping, heat intolerance, hand tremors, rapid and irregular heartbeat, frequent bowel movements or diarrhea, weight loss, mood swings and goiter, which is an enlarged thyroid that may cause your neck to look swollen.

Common symptoms of hypothyroidism are fatigue, weight gain, a puffy face, cold intolerance, joint and muscle pain, constipation, dry and thinning hair, decreased sweating, heavy or irregular menstrual periods, impaired fertility, depression and a slowed heart rate.

Women are much more likely than men to develop thyroid disease. It’s also more common among people older than age 60.

It’s particularly important if you’re a woman with hyperthyroidism to discuss your condition with your doctor before becoming pregnant. Uncontrolled hyperthyroidism raises the chance of miscarriage, preterm delivery and preeclampsia, a potentially serious complication that increases blood pressure.

Thyroid treatments aim to bring thyroid hormone levels back to normal. Treatment depends on the type of thyroid disease and its cause.

If you suspect you might have thyroid disease, talk to a health care professional. Several tests are available to help confirm a diagnosis and find its cause. The American Thyroid Association (which isn’t affiliated with NIH) recommends that adults, particularly women, have a blood test every 5 years, starting at age 35, to detect thyroid problems.

Source: newsinhealth.nih.gov

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If you really think about it, each one of us is already a modeler. We create mental models every time we try to predict the outcome of a sporting event, an election or the stock market. But our mental models are based on limited facts and are skewed by our perspective and assumptions. Computer models, in contrast, rely on objective data. They can account for many more factors than the human brain, and they can be tested, adjusted and verified.

Computer models have many potential uses. Simulations of how people behave in the face of natural disasters could help prepare local and national officials to respond. Mathematically capturing the behavior of pests or beneficial insects could improve agricultural practices. And modeling social networks can help doctors develop better strategies to change unhealthy behaviors.

Using computer models, researchers are trying to predict—and propose ways to minimize—the effects of a future flu pandemic. Flu outbreaks in 1918, 1957 and 1968 killed millions worldwide. NIH-funded researchers looked at the measures that different health officials took in past pandemics and analyzed their effects. They used this information to build computer models and confirm the models could simulate what happened during past outbreaks. Then they used them to simulate an outbreak of pandemic flu as it spread throughout a large city.

The simulations helped researchers identify public responses that could significantly slow the spread of infection. Tactics like closing schools and giving anti-viral treatments, the models found, could give researchers more time to develop vaccines. The models are also helping researchers understand how people react to these public health measures and how to optimize their timing.

Computer models can help researchers combat other diseases, too. Last year, NIH-funded researchers created a computer model of cholera transmission in Matlab, Bangladesh. Cholera bacteria, which spread through contaminated water and food, can cause severe symptoms that include diarrhea, vomiting and leg cramps. The disease can lead to death by dehydration in a matter of hours if left untreated.

The computer simulation showed that cholera transmission could be controlled if about 50% of the population got an oral vaccine. Public health officials now know they could likely control cholera with a modest investment using a mass vaccination program. These types of models can help health officials figure out which vaccination strategies would work best in different settings.

Last year, NIH-funded researchers computerized weight, height and other data collected over a 32-year period from a socially intertwined network of over 12,000 adults. They found that friendships can have a crucial influence on a person’s weight. In fact, the likelihood of becoming obese increased by nearly 57% if a close friend had become obese.

This year, using the same technique, the scientists reported that close relationships exert a strong influence on smoking. The greatest effect was in married couples. When a husband or wife quit smoking, it reduced the chance of their spouse smoking by about 67%.

This research suggests that it may be possible to harness social networks to help people change behaviors, such as smoking, for the better.

No computer model is perfect. Even the best can only take into account the things that we know about and can measure. Modelers also routinely have to make decisions about what to include and exclude.

Researchers continue to design and test new computer models. As they improve, they give researchers new insights into the most effective ways to affect people’s health.

Source: News in Health

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10 Things You Probably Don’t Know about Your Body and Your Health:
Health knowledge is essential as the basis for personal health maintenance — with an eye toward longevity. You may not get all these numbers right in a pop quiz; but it is important to know of them and that they are key indicators of the state of your health.

1. Your Total Cholesterol. The National Cholesterol Education Program NCEP, a section of the National Health Institutes, publishes recommended cholesterol levels for maintaining low risk for health problems, specifically cardiovascular health. A measurement below 200 is the “desirable level that puts you at lower risk for coronary heart disease.” If your total cholesterol number is not below 200, then get it down there!

2. HDL or high density cholesterol. Cholesterol is an unwelcome fatty substance that tends to collect in coronary arteries (of some persons) and interfere with blood flow. It is chemically distinguished as high density cholesterol (HDL) and low density cholesterol (LDL). HDL is found to be on its way out of your system. A good level, number for HDL is 40. Lower than that calls for correction. Exercise will help.

3. Your LDL — low density cholesterol. This is the most important cholesterol measurement, because it indicates cholesterol that is building up. Heart experts want it to be at a level below 100 mg/dl (milligrams per deciliter of blood). If you are already at risk for or diagnosed with cardiovascular disease, it should be down around 70. And researchers have found that at even lower levels, heart disease (atherosclerosis) begins to recede. A very good thing.

4. Triglycerides. Like cholesterol, these are fats (lipids) in the blood. They are associated with overweight and are stored in fat tissue. Exercise reduces them. In excess, they are a risk for heart disease. A good level for triglycerides is 150 mg/dl. A routine “lipid profile” blood test will include the triglyceride level and the cholesterol levels.

5. FPG. Fasting plasma glucose. This is the measure of glucose (sugar) in the blood — a test for diabetes. It is measured in blood drawn after an 8 hour (usually overnight) fast. Diabetes is indicated when the glucose level in the blood is over 125 mg/dl. That is, the body’s metabolism is not able to process glucose in the blood sufficiently. Levels 125 and below, down to 95, are regarded as risky, because they may be on their way to diabetes and they tend, like diabetes, to do damage to bodily organs. This stage is called is “pre-diabetes” and requires treatment.

6. A1C is the chemical name of a component of hemoglobin, the protein that carries oxygen in the blood (and also gives blood its red color). It tends naturally to bond with glucose in the blood stream. But if there is too much glucose available (diabetes), the A1C level increases. A normal measure is 5%. Higher indicates that diabetes is uncontrolled. The hemoglobin A1C test shows the average level over a 3-4 month period.

7. OGTT is another way of testing your glucose level. The letters stand for Oral Glucose Tolerance Test. In this test the patient drinks a sugary glucose drink — like an ultra-sweet cola… If the body is unable to metabolize the glucose efficiently it will remain and show up at high levels. Diabetes is diagnosed if after two hours a blood test shows the level at 200 mg/dl. Below 140 is normal.

8. BMI — your body mass index. On this measure using the formula weight/lb divided by height/in(2) (squared), a calculation of 30 is considered obese; 40 is morbid obese. You’re overweight at 25. The more you are below 30, the better. Other factors, such as body shape, may influence this measurement and there are variations in the application of the formula. It is, however, a good starting point for watching your weight. In a related measure, a 40+ inch waist for a man and 35+ for a woman are characteristics of the metabolic syndrome.

9. BP. Blood pressure. The first thing your health care provider does when you visit is take your blood pressure. Because blood pressure levels tell much about your health condition at any moment in time. A healthy blood pressure is in the range of 120-140 in the systolic (top number) and below 90 in the diastolic (bottom number). The numbers reflect the level and movement of mercury in an instrument called a sphygmomanometer (sphygmos being Greek for pulse) as it senses pressure through an inflated sleeve wrapped on your arm. Abnormally high blood pressure is a clue to something unhealthy going on in the body. When it is chronically high, it is a condition called hypertension, which requires aggressive treatment, because it can lead to very serious health problems . . . like stroke or heart attack. Ask how you can monitor your blood pressure at home.

10. Homocysteine. In its ongoing effort to discover what causes people to have heart attacks, medical science has identified a number biochemical factors; one of them is homocysteine. It is a kind of amino acid produced naturally; but it has been found in high levels in persons who have heart disease. Current standards regard a homocysteine level below 16 mg/dl in the blood as desirable. Higher than 16, efforts should be made to reduce it . . . mainly though dietary supplements, such as folic acid and vitamins B-6 and B-12.

And also . . .

High Sensitivity C-reactive protein (CRP). This is a measure that has lately been considered critical. Because current research evidence shows that heart disease, atherosclerosis, displays a certain inflammation of the coronary arteries. CRP is the body’s response to inflammation; hence, the presence of CRP in the blood is a marker of an atherosclerotic condition.

The bottom line of this month’s Longevity Report is that knowing your “numbers” is not only critical to your health maintenance, but it is also easy information to obtain. Pay attention to your doctor’s reports. Or ask for more information. The more you know about the status of your body’s health, the more are you in position to improve it — for the long term.

Source: The Heart, Diabetes, and Weight Loss Centers of New York

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Daniel F. Kripke, M.D.’s article, based on a compilation of studies involving sleeping pills and cancer, has just been published in the Journal of Sleep Research. It appears with an editorial authored by Dr. Gary D. Friedman, an epidemiologist at Stanford University’s School of Medicine and adjunct investigator at the Kaiser Permanente Medical Care Program who has vast experience in investigating the carcinogenic effects of drugs.

The effects of 556 person-years of taking either zaleplon (Sonata), Eszopiclone (Lunesta), ramelteon (Rozerem) and zolpidem (Ambien) were assessed, compared to a control group who took a placebo over 230 person-years. Kripke found eight non-melanoma skin cancers and four tumors of uncertain malignancy in the groups that took sleeping pills compared to none in the placebo groups.

Lab animals given high doses of hypnotic drugs are known to have developed kidney, thyroid and testicular cancers and suffer chromosome damage, which is a sign of carcinogenicity. Although a direct causal link between cancer and sleeping pills has still not been proven, Kripke urges additional studies as well as serious epidemiological investigations, given the fact that sleeping pill use is constantly rising and three new types have been put on the market in addition to Ambien (zolpidem), the most popular brand used in the United States.

“Because the compilation mixes diverse studies of several drugs and the number of cancers observed during controlled hypnotics trials remains small,” Kripke writes, “this preliminary analysis should be viewed as an investigative step, rather than sufficient proof that modern hypnotics cause cancer.”

But both he and Friedman — who congratulated Kripke for raising this important issue even though the reviewer remained somewhat skeptical of a causal link — urge caution and suggest that regulatory bodies and the U.S. National Institutes of Health keep an eye on cancer cases reported by sleeping pill users.

The Journal of Sleep Research is published by Wiley-Blackwell and can be accessed online at http://www.blackwellpublishing.com/jsr

Source: SCRIPPS CLINIC

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Ninety bicycling police officers from 5 metropolitan regions in the U.S. (Northwest, Southern, Desert West, Midwest, and Southeast) using traditional saddles were evaluated prior to changing saddles and then again after 6 months of using the noseless bicycle saddle.

The findings show that use of the noseless saddle resulted in a reduction in saddle contact pressure in the perineal region. There was a significant improvement in penile tactile sensation, and the number of men indicating they had not experienced genital numbness while cycling for the preceding 6 months rose from 27 percent to 82 percent using no-nose saddles. Use of the noseless saddle also resulted in significant increases in erectile function as assessed by the initial evaluation, but there were no significant changes noted in Rigiscan® measures, a method used to record penile rigidity while the subject sleeps. With few exceptions, bicycle police officers were able to effectively use no-nose saddles in their police work and 97 percent of officers completing the study continued to use the no-nose saddle afterward.

Dr. Steven Schrader of the National Institute for Occupational Safety and Health in Cincinnati, first author of the study and the recent co-recipient along with his research team of a Bullard-Sherwood Research-to-Practice Award in the Interventions Category for “Health Effects of Occupational Cycling” stated, “No-nose saddles are a useful intervention for bicycling police officers alleviating pressure to the groin and improving penis health. Different saddle designs may require some re-learning of ‘how to ride a bicycle,’ but the health benefits to having unrestricted vascular flow to and from the penis and less penile numbness is self-evident.”

Dr. Irwin Goldstein, Director, Sexual Medicine, Alvarado Hospital, San Diego C.A., and editor-in-chief of The Journal of Sexual Medicine, wrote an accompanying editorial entitled “The A, B, C’s of The Journal of Sexual Medicine: Awareness, Bicycle Seats, and Choices”.

“For the first time, we have a prospective study of healthy policemen riding bikes on the job, using wider, no-nose bike saddles for 6 months. Not only did their sensation improve, their erectile function also improved. Changing saddles changed physiology. This is a landmark study for our field that that is important for future riders, and modification of lifestyle showing improvement without any active treatment.”

_________________________________________________________________

The study and editorial are published in the August 2008 issue of The Journal of Sexual Medicine.

Source: Blackwell Publishing

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“American consumers are entitled to have safe and effective drugs,” said Hanaway.

The seizure followed an inspection of several of the company’s plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

“The FDA is committed to taking enforcement action against firms that circumvent the drug approval process,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace.”

In a routine inspection of KV Pharmaceutical’s facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company’s manufacturing and distribution of other unapproved drug products. Today’s action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

• PhenaVent Capsules
• PhenaVent LA Capsules
• PhenaVent PED Capsules
• Ethezyme Papain-Urea Ointment
• Ethezyme 650 Papain-Urea Ointment
• Ethezyme 830 Papain-Urea Ointment
• Hista-Vent DA Tablets
• Meperidine/Promethazine Capsules
• Pseudovent Capsules
• Pseudovent 400 Capsules
• Pseudovent PED Capsules
• Tri-Vent DM Syrup
• Tri-Vent DPC Syrup
• Hydro-Tussin DM Liquid
• Hydro-Tussin CBX Syrup
• Hydro-Tussin DHC Syrup
• Hydro- Tussin EXP Syrup
• Hydro-Tussin HD Syrup
• Hyoscyamine Sulfate Sublingual Tablets
• Hydroquinone 4% Cream
• Hydroquinone 4% Cream with Sunscreen
• Bromfenex Extended Release Capsules
• Bromfenex PD Extended Release Capsules

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

“The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date,” said Deborah M. Autor, director of the FDA’s Office of Compliance within CDER. “When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company’s other unapproved drugs.”

In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs—Compliance Policy Guide (CPG).” This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.

Source: FDA

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At the American Academy of Dermatology’s Summer Academy Meeting 2008 in Chicago, dermatologist Sharon E. Jacob, MD, FAAD, assistant clinical professor of pediatrics and medicine (dermatology) at the University of California, San Diego, discussed the dangers of black henna tattoos and how dermatologists are treating an increasing number of patients, including very young children, with skin problems from allergic reactions to PPD.

Natural henna used for temporary tattoos is made from leaves of the lawsonia inermis plant, which provides a vegetable coloring that comes in shades of brown, green or red. Temporary coloring (dyeing) of the skin with natural henna is considered harmless and only lasts for a few days. To increase the intensity of the tattoo beyond which can be attained with natural henna color and to prolong the longevity of the temporary tattoo from days to weeks, some henna tattoo artists are adding PPD (commonly also used for black hair dye) into the henna mix. This turns the tattoo black.

The U.S. Food and Drug Administration (FDA) prohibits the direct application of PPD to the skin because of its known health risks. However, since the tattoo industry is not regulated, people are still getting black henna tattoos and exposing themselves to serious medical problems.

“Perhaps the most alarming issue we are seeing with black henna tattoos is the increase in the number of children — even children as young as four — who are getting them and experiencing skin reactions,” said Dr. Jacob. “Kids make up a significant portion of the population that receives temporary tattoos, because parents mistakenly think they are safe since they are not permanent and are available at so many popular venues catering to families. In fact, nothing could be further from the truth.”

Dr. Jacob noted that to date, there have been hundreds of case reports of allergic contact dermatitis from black henna tattoos, with reactions ranging from mild eczema to blistering and even permanent scarring. The first sign of a reaction is typically redness and itching, followed by bumps, swelling and then blisters. Topical steroids can be used to stop the reaction, but Dr. Jacob explained that whether or not any scarring occurs depends on the depth and severity of the inflammation.

In addition, some people may become sensitized to PPD from just one exposure — meaning that the immune system becomes prepared to remember the chemical to which it has been exposed or a chemical with a similar structure. When this happens, a person can develop a lifelong sensitivity to PPD and an allergy can cause a cross reaction to other compounds, including certain medications. For example, use of some heart, hypertension and diabetes medications, and even some anesthetics used in topical hemorrhoid preparations or oral gels, can lead to allergic reactions in people previously sensitized to PPD.

“Each exposure to PPD re-challenges the immune system, so each time you get a black henna tattoo or use a hair dye that contains PPD, there is an increased risk of having a reaction,” said Dr. Jacob. “Many people are sensitized to PPD, but don’t have a reaction to it. However, each time you are exposed to black henna, you increase your risk of developing a lifelong allergy to it.”

Dr. Jacob advised if one does choose to obtain a henna tattoo, only do so if you can be certain that only vegetable henna is used, not PPD-adulterated henna. “Unless the artist can tell you exactly what’s in the tattoo, don’t get one,” said Dr. Jacob.

The American Academy of Dermatology Association (AADA) endorses a ban on the practice of applying PPD-adulterated henna tattoos, and some state dermatology societies have started posting warnings on their Web sites about black henna tattoos.

For any skin reactions that develop from a temporary tattoo, Dr. Jacob recommended that people see their dermatologist for proper diagnosis and treatment. If a serious reaction occurs, such as severe blistering or swelling, she said seek immediate medical attention.

Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 15,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or http://www.aad.org/.

Source: American Academy of Dermatology

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