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Farah & Farah E-Newsletter: June 2015

FDA Warns About Facial Fillers

The U.S. Food and Drug Administration (FDA) is issuing a warning about facial fillers, which are injected to soften wrinkles.

Because they are injected into the face, the needle can accidentally enter blood vessels and cause a blockage of blood flow to tissues. The filler material can also travel through the blood vessel and cause blindness, stroke or death of the underlying facial structure, the agency said in a news release.

Fortunately, the unintentional risk is rare, according to the FDA. The Cleveland Clinic estimates adverse reactions occur one in every 10,000 cases.

An agency analysis found the most likely areas for blockages to occur were between the eyebrows, around the nose, the eyes and on the forehead. The damage is sometimes irreversible.

The FDA issued a Safety Communication May 28, 2015 for consumers, dermatologists, plastic surgeons and anyone who might perform soft tissue fillers, also called dermal fillers. It was made aware of the issue through medical device reports and clinician experts.

Fillers are used to smooth out wrinkles and augment an area such as cheeks or lips. They are used by both women and men trying to appear younger.

The materials used are not implicated here but are usually collagen, hyaluronic acid, a type of sugar derived from the cartilage of rooster combs, calcium hydroxylapatite, a type of mineral, and/or Poly-L-Lactic acid or PLLA, a man made polymer.

The only area approved for temporary treatment with fillers by the FDA are nasolabial folds or marionette lines. Permanent fillers are approved by the FDA only for treatment of nasolabial folds. Some absorbable fillers are approved for lip and cheek augmentation.

Medical professionals administering fillers should be aware of the symptoms of a blood vessel injection – stroke-like symptoms, a white appearance of the skin near the injection site, discomfort, difficulty speaking, severe headache or confusion, vision changes and /or pain shortly after the injection.

Manufacturers will be asked to update their label so healthcare workers and their patients will have full informed consent about the adverse events they may encounter, no matter how small the risk.

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Use of E-Cigs by Teens Soars

While tobacco smoking has fallen out of favor among the “cool” teen crowd these days, the use of e-cigarettes is more popular than ever.

Middle and high school students use of e-cigarettes tripled from 2013 to 2014, according to federal data, surprising the Food and Drug Administration (FDA) which lightly regulates the products.

That represents the first rise in smoking during a time when tobacco use among teens dropped from 16 percent in 2011 to just nine percent in 2014, according to the report. Many teens reportedly believe e-cigarettes are a safer alternative to smoking tobacco.

Published in the weekly Morbidity and Mortality Weekly Report by the Centers for Disease Control and Prevention (CDC), the survey finds 450,000 middle school students and two million high school students now use e-cigarettes.

“Nicotine exposure at a young age may cause lasting harm to brain development, promote addiction and lead to sustained tobacco use,” warns Dr. Tom Frieden of the CDC.

E-cigs or electronic cigarettes are shaped like cigarettes and smokers inhale a vapor created from the nicotine-laced fluid inside. The debate is whether the vapor contains enough nicotine to be a health hazard or to get kids hooked, serving as a "gateway" product to tobacco. There are also unknown additives in the liquid sometimes compounded by "vap shops" which mix nicotine with various flavorings.

E-cigs are not cheap. Beginning at $40 and going up to $200 for a starter kit, the fluid can cost upward of $20 a bottle. Nor surprising, many e-cig companies are owned by Big Tobacco, such as MarkTen, owned by parent company Altria, the maker of Marlboro cigarettes.

The concern is also that just the act of smoking may hook a new generation on cigarettes, keeping revenue streams healthy for the tobacco giants.

Anti-smoking advocates believe e-cigarettes are undoing years of progress made educating the public, especially the young, about the hazards of smoking.

"It’s another generation being hooked by the tobacco industry. It makes me angry," said Frieden to the New York Times.

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Study Will Find Whether Plastics Raise Breast Cancer Risk

A study is about to get underway to determine the possible link between phthalates and a woman’s breast cancer risk.

Phthalates (pronounced THAL-ates) are chemicals that make plastic more flexible, also known as “plasticizers” and they are ubiquitous – found in hundreds of products, everything from shampoos, flooring, packaging, cosmetics, food can liners and children’s toys.

An epidemiologist at the University of Massachusetts Amherst, Prof. Katherine Reeves, of the School of Public Health, will lead the three-year investigation.

Phthalates have been found in virtually every American and even in human breast milk.

Researchers will determine the amount of 11 phthalate metabolites found in urine samples taken from 500 women at a baseline, year one, and year three. They will be compared to 1,000 healthy women who serve as controls. The expectation is that there will be variations in phthalate exposure.

So far, no studies have measured phthalate metabolites prior to a cancer diagnosis.

Listed as a reproductive and developmental toxicant by California’s Proposition 65, phthalates are endocrine disruptors and androgen blockers linked to an early onset of puberty, interference with the hormone system, genital and reproductive defects and low sperm count in adult males, reports Zero Breast Cancer, a nonprofit group in California.

Humans are exposed to phthalates through plastic packaging, breathing air containing plastic vapors or particles, through hand-to-mouth contact (children’s toys), medical tubing and children’s toys. Also avoid contact with vinyl flooring, detergents, plastic raincoats, shower liners, hairsprays, soaps and nail polishes.

Consumers should look for DBP (dibutylphthalate) used in nail polishes to reduce cracking; DMP (dimethylphthalate) found in hair sprays to keep hair flexible; and DEP (diethylphthalate) used as a solvent and fixative in fragrances.

The U.S. Food and Drug Administration reports DBP and DMP are rarely used while DEP is still a common additive to cosmetics. While labels will disclose some phthalates, consumers cannot determine if a fragrance has the chemical added, nor can you know about products used in salons. Look for the additive “fragrance” to avoid DEP.

Look for the number "3" inside the universal recycling triangle symbol molded on the bottom of a consumer product to determine if phthalates are used in that product.

The Centers for Disease Control and Prevention reports women have a higher rate of phthalates in their urine than men.

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Additional Possible Stories Ahead

As Melanoma Rates Soar, a New Drug Shrinks the Skin Cancer

The CDC reports the case of aggressive skin cancer, melanoma, are on the rise, but just in time a combination of drugs finds tumors are stopped in almost 60% of cases.

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Lumber Liquidators Facing Class-Action Over Dangerous Formaldehyde Flooring

Levels of formaldehyde, present in certain flooring manufactured by Lumber Liquidators and sold in Florida and three other states, exceeds the California Air Resources Board and Formaldehyde Emissions Standards at levels up to 20 times. Formaldehyde is a known carcinogen and is also linked to respiratory issues and asthma. In response, the company says it is offering consumers free home air quality tests.

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New Diabetes Drug Warning from FDA

The FDA warns a drug used to treat type 2 diabetes may cause a risk of ketoacidosis, characterized by a buildup of acids in the body that can be life-threatening.

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Nail Salons and the Cost of Perfect Nails

Nail salons abound with stories of miscarriages and cancer among workers as well as painful skin afflictions. A growing body of research points to solvents and chemicals used in beauty products.

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Risperdal and Boy Breast Growth

A biochemist at Johnson & Johnson testifies the company knew about the antipsychotic drug Risperdal and never turned over internal documents to the FDA looking into the link between boy’s breast growth and the drug.

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The attorneys of Farah & Farah in Jacksonville, Florida have experience with personal injury, medical malpractice, product liability, workers’ compensation, social security, injury and negligence lawsuits. Eddie Farah and our team of Jacksonville attorneys are proud to represent working people and families throughout the country.

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