USFDA Consumer Alert: Wrinkle Relief: Injectable Cosmetic Fillers

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Dermal Fillers

In the quest for youth—or at least a more youthful appearance—women and men are seeking treatments to minimize laugh lines, crow’s feet, and forehead furrows. A popular treatment involves injecting cosmetic wrinkle fillers into the face.

Injectable cosmetic wrinkle fillers are soft tissue fillers approved as medical devices by the Food and Drug Administration (FDA). These devices are injected into the skin to help fill in facial wrinkles, restoring a smoother appearance. Most of these wrinkle fillers are temporary because they are eventually absorbed by the body.

Some people may need more than one injection to achieve the wrinkle-smoothing effect. The effect lasts for about six months or longer.

Successful results depend on

  • health of the skin
  • skill of the doctor
  • type of filler uses

Uses:

FDA has approved absorbable injectable cosmetic wrinkle fillers for correcting soft tissue contour defects, such as moderate and severe wrinkles and folds. Some absorbable fillers are approved for restoring or correcting the signs of facial fat loss in people with human immunodeficiency virus (HIV).

FDA has also approved two absorbable injectable wrinkle fillers for lip augmentation in patients over the age of 21.

The only non-absorbable FDA-approved injectable cosmetic wrinkle filler is for correcting facial tissue around the mouth.

FDA-approved cosmetic wrinkle fillers should not be used for

  • increasing breast size (breast augmentation)
  • implanting into bone, tendon, ligament, or muscle
  • implanting into blood vessels

Filler Materials

Wrinkle fillers are made of various types of materials, and some include a combination of products. Some products also contain lidocaine, which numbs the skin at the injection site.

The materials used in injectable cosmetic wrinkle fillers include

Temporary (absorbable) fillers

  • Collagen injections are made of highly purified cow or human collagen. Collagen is a natural protein that is a major component of skin and other tissues in the body.
  • Hyaluronic acid gel is a protective lubricating gel, produced naturally by the body, that binds with water to plump the skin.
  • Calcium hydroxylapatite is a mineral that is a major component of bone. Calcium hydroxylapatite is a well-matched (biocompatible) material that dissolves in the body (biodegradable) and is implanted in the form of a gel.
  • Poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, synthetic material from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches and bone screws.

Permanent (non-absorbable) filler

  • Polymethylmethacrylate beads (PMMA microspheres) are tiny round, smooth plastic particles that have been tested to be biocompatible. They are not absorbed by the body.

Risks:

Getting injected with cosmetic wrinkle fillers is an elective procedure. As with any medical procedure, it poses risks.

Possible side effects include

  • infection
  • bruising
  • redness
  • swelling
  • pain
  • tenderness
  • itching and rash
  • raised bumps of skin (nodules or granulomas) that may need to be surgically removed
  • death of skin, which may cause disfiguration, if the cosmetic wrinkle filler is injected and blocks a blood vessel
  • sore (abscess) at the injection site
  • wrinkle filler that breaks through the skin
  • open or draining wounds
  • blurred vision and flu-like symptoms
  • increased allergic reaction that may lead to a severe allergic reaction (anaphylactic shock) that requires emergency medical help. (Your doctor may request a pre-treatment allergy test to determine if you are allergic to the filler.)

Most side effects occur shortly after injection and go away within seven days. In some cases, side effects may emerge weeks, months, or years later. A non-absorbable filler may cause long-term side effects.

You should not use cosmetic wrinkle fillers if any of the following applies to you:

  • severe allergies marked by a history of anaphylactic shock
  • allergy to cow collagen or eggs
  • allergy to lidocaine
  • inflamed or infected skin
  • prone to form excessive scarring (keloid) or thick scarring (hypertrophic scars)
  • bleeding disorder
  • active inflammatory condition (cysts, pimples, rashes or hives) or infection; you should postpone treatment until the condition is controlled.

Source: USFDA

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Indian pharma companies secure 154 ANDAs approval from US FDA during 2013

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The Indian pharmaceutical companies and their subsidiaries have established strong presence in the United States and other regulated markets with higher investment in research and development (R&D) during the last couple of years. Indian companies received final approval for 154 ANDAs during the year 2013 from US FDA and 38 tentative ANDAs approval during 2013.

The US FDA has approved a total 400 final ANDAs during the year 2013 as against 476 in the previous year and it approved total 86 tentative ANDAs during 2013 as against 94 during 2012. Out of the total approvals, Indian companies grabbed 38.5 per cent final approval during 2013 as against 37.4 per cent in the previous year. Similarly, Indian companies received 44.2 per cent of total tentative approvals as compared to 42 per cent in the previous year.

The US FDA final approval of 400 ANDAs during 2013 was the lowest in the last five years. During 2012, it approved 476 ANDAs as against 431 ANDAs in 2011. It approved 418 ANDAs in 2010 and 419 during 2009.

Sun Pharmaceutical Industries and its subsidiaries viz, Taro Pharmaceutical Industries and Caraco Pharmaceutical Laboratories, received highest number ANDAs approvals from US FDA during 2013. Sun Pharma and its subsidiaries received 30 ANDAs approvals followed by Lupin 21, Aurobindo Pharma 19, Dr Reddy’s Laboratories 14, Emcure Pharmaceuticals 13, Glenmark Generics 8, Torrent Pharmaceuticals 6, Cadila Healthcare Group and Claris Lifesciences 5 each. Alembic Pharmaceuticals and Hetero Laboratories received 4 ANDAs approval each during 2013. Ipca Laboratories, Jubilant Life Sciences, Strides Arcolab and Alkem Labs received 3 approvals each. Other major companies like Ranbaxy Laboratories received only one approval and Wockhardt, Cipla, Macleods Pharma and Micro Labs received 2 approvals each during 2013.

Lupin received highest tentative approval for 10 ANDAs during 2013 and was followed by Aurobindo Pharma 6, Sun Pharmaceuticals 5 and Alembic Pharmaceuticals 4. Further, Zydus Pharma received 3 tentative approvals during 2013.

Indian companies are investing in R&D to tap profitable regulated market with higher approval for ANDAs and DMFs. The company filed 13 ANDAs with US FDA and its cumulative filings reached at 294. Similarly, it filed 8 DMFs during the second quarter and cumulative total reached at 175. Further, it filed 47 API DMF/COS in other key regulated market. The cumulative approvals in US stood at 184 ANDAs, followed by South Africa 64, Australia 46, and Canada 39. For the first half ended September 2013, Aurobindo’s consolidated net sales moved up by 34.3 per cent to Rs.3,597 crore from Rs.2,678 crore in the similar period of last year. Its net profit went up sharply to Rs.253.55 crore from Rs.93.44 crore, a growth of over 171 per cent.

Lupin’s R&D expenditure increased sharply to Rs.217 crore during the second quarter ended September 2013 from Rs.93.5 crore and it worked out to 8.3 per cent of net sales. It filed 7 ANDAs and received approval for 6 ANDAs during the quarter under review. Cumulative ANDA filings with the US FDA now stand at 183 with the company having received 92 approvals to date. It also received first MAA approval from European regulatory authorities in the quarter.

For the first half ended September 2013, Dr Reddy’s Laboratories R&D expenditure increased by 64 per cent to Rs.544 crore from Rs.332 crore. As of the end of September 2013 quarter, it filed 4 ANDAs and 62 ANDAs are pending for approval with the US FDA.

Orchid Chemicals has filed 43 ANDAs in US up to September 2013 and received approval for 32 ANDAs. Similarly, it filed 30 marketing authorizations in the EU region and received 30 approvals. The company filed 90 DMFs in US and 21 filings in European market. It filed 8 DMFs globally, including one each in the US and Europe. The cumulative number of DMF filings as of end of September stood at 590.

Thus, the Indian companies have successfully stepped up the ANDA filings and approvals form US FDA during 2013 and now set to spread there business operations in the highly regulated markets. Despite quality problem regarding few major players, the Indian companies will able to generate better level of revenues with higher approval rates.

Source: PharmaBiz

USFDA: Consumer Alert : Temporary Tattoos May Put You at Risk

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Temporary Tattoo

Spring break is on the way, or maybe summer vacation. Time to pack your swim suit, hit the beach, and perhaps indulge in a little harmless fun. What about getting a temporary tattoo to mark the occasion? Who could it hurt to get a temporary tattoo?

It could hurt you, if you actually get one. Temporary tattoos typically last from three days to several weeks, depending on the product used for coloring and the condition of the skin. Unlike permanent tattoos, which are injected into the skin, temporary tattoos marketed as “henna” are applied to the skin’s surface.

However, “just because a tattoo is temporary it doesn’t mean that it is risk free,” says Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors. Some consumers report reactions that may be severe and long outlast the temporary tattoos themselves.

MedWatch, FDA’s safety information and adverse event (bad side effects) reporting program, has received reports of serious and long-lasting reactions that consumers had not bargained for after getting temporary tattoos. Reported problems include redness, blisters, raised red weeping lesions, loss of pigmentation, increased sensitivity to sunlight, and even permanent scarring.

Some reactions have led people to seek medical care, including visits to hospital emergency rooms. Reactions may occur immediately after a person gets a temporary tattoo, or even up to two or three weeks later.

Not Necessarily Safe

You may be familiar with henna, a reddish-brown coloring made from a flowering plant that grows in tropical and subtropical regions of Africa and Asia. Since the Bronze Age, people have used dried henna, ground into a paste, to dye skin, hair, fingernails, leather, silk and wool. This decoration—sometimes also known as mehndi—is still used today around the world to decorate the skin in cultural festivals and celebrations.

However, today so-called “black henna” is often used in place of traditional henna. Inks marketed as black henna may be a mix of henna with other ingredients, or may really be hair dye alone. The reason for adding other ingredients is to create a tattoo that is darker and longer lasting, but use of black henna is potentially harmful.

That’s because the extra ingredient used to blacken henna is often a coal-tar hair dye containing p-phenylenediamine (PPD), an ingredient that can cause dangerous skin reactions in some people. Sometimes, the artist may use a PPD-containing hair dye alone. Either way, there’s no telling who will be affected. By law, PPD is not permitted in cosmetics intended to be applied to the skin.

You may see “black henna” used in places such as temporary tattoo kiosks at beaches, boardwalks, and other holiday destinations, as well as in some ethnic or specialty shops. While states have jurisdiction over professional practices such as tattooing and cosmetology, that oversight differs from state to state. Some states have laws and regulations for temporary tattooing, while others don’t. So, depending on where you are, it’s possible no one is checking to make sure the artist is following safe practices or even knows what may be harmful to consumers.

A number of consumers have learned the risks the hard way, reporting significant bad reactions shortly after the application of black henna temporary tattoos.

  • The parents of a 5-year-old girl reported that she developed severe reddening on her forearm about two weeks after receiving a black henna temporary tattoo. “What we thought would be a little harmless fun ended up becoming more like a nightmare for us,” the father says. “My hope is that by telling people about our experience, I can help prevent this from happening to some other unsuspecting kids and parents.”
  • The mother of a 17-year-old girl agrees. “At first I was a little upset she got the tattoo without telling me,” she says. “But when it became red and itchy and later began to blister and the blisters filled with fluid, I was beside myself.” She explains that as a nurse, she’s used to seeing all manner of injuries, “but when it’s your own child, it’s pretty scary,” she says.
  • And another mother, whose teenager had no reaction to red henna tattoos, describes the skin on her daughter’s back as looking “the way a burn victim looks, all blistered and raw” after a black henna tattoo was applied there. She says that according to her daughter’s doctor, the teenager will have scarring for life.

Source : USFDA

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USFDA approves Post – Natal chromosomal variations detection kit

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Baby

U.S. Food and Drug Administration authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes.

According to the National Institutes of Health and the American Academy of Pediatrics, two to three percent of children in the United States have some form of intellectual disability. Many intellectual and developmental disabilities, such as Down syndrome and DiGeorge syndrome, are associated with chromosomal variations.
“This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “The FDA’s review of the test provides clinical laboratories with information about the expected performance of the device and the quality of the results.”
The FDA reviewed the Affymetrix CytoScan Dx Assay through its de novo classification process, a regulatory pathway for some novel low-moderate-risk medical devices.
For the de novo petition, the FDA’s review of the CytoScan Dx Assay included an analytical evaluation of the test’s ability to accurately detect numerous chromosomal variations of different types, sizes, and genome locations when compared to several analytically validated test methods.  The FDA found that the CytoScan Dx Assay could analyze a patient’s entire genome and adequately detect chromosome variations in regions of the genome associated with intellectual and developmental disabilities.
Additionally, the agency’s review included a study that compared the performance of the CytoScan Dx Assay to tests that are commonly used for detecting chromosomal variations associated with a developmental delay or intellectual disability. A comparison of test results from 960 blood specimens showed the CytoScan Dx had improved ability over commonly used tests, including karyotyping and FISH chromosomal tests, to detect certain chromosomal abnormalities.
This device should not be used for stand-alone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer. The test results should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate. Interpretation of test results is intended to be performed only by health care professionals who are board certified in clinical cytogenetics or molecular genetics.
Affymetrix CytoScan Dx Assay is manufactured by Affymetrix, Inc., located in Santa Clara, Calif.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: USFDA

 

Decorative Contact Lenses: Is Your Vision Worth It?

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eye

Wouldn’t it be cool to have Twilight vampire eyes for Halloween?

Or deep violet eyes to match your purple sweater?

How about your favorite sports team’s logo on your eyes just for fun?

You can have all of these looks with decorative contact lenses (also called fashion contact lenses or color contact lenses, among other names). These lenses don’t correct vision—they just change the appearance of the eye.

But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law.

They are not “one size fits all.” An eye doctor (ophthalmologist or optometrist) must measure each eye to properly fit the lenses and evaluate how your eye responds to contact lens wear. A poor fit can cause serious eye damage, including

  • scratches on the cornea (the clear dome of tissue over the iris – the part of the eye that gives you your eye color)
  • corneal infection (an ulcer on the cornea)
  • conjunctivitis (pink eye)
  • decreased vision
  • blindness
  • Places that sell decorative lenses without a prescription may give you few or no instructions on how to clean and care for your lenses.

Failure to use the proper solution to keep contact lenses clean and moist can lead to infections, says Bernard Lepri, O.D., M.S., M.Ed., an optometrist at FDA. “Bacterial infections can be extremely rapid, result in corneal ulcers, and cause blindness—sometimes within as little as 24 hours if not diagnosed and treated promptly.”

“The problem isn’t with the decorative contacts themselves,” adds Lepri. “It’s the way people use them improperly—without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care.”

Where NOT to Buy Contact Lenses

FDA is aware that many places illegally sell decorative contact lenses to consumers without valid prescriptions for as little as $20.

You should never buy lenses from:

  • street vendors
  • salons or beauty supply stores
  • boutiques
  • flea markets
  • novelty stores
  • Halloween stores
  • record or video stores
  • convenience stores
  • beach shops
  • Internet (unless the site requires a prescription)

These are not authorized distributors of contact lenses, which are prescription devices by federal law.

How to Buy Decorative Contact Lenses Safely

Get an eye exam from a licensed eye doctor (ophthalmologist or optometrist), even if you feel your vision is perfect.

Get a valid prescription that includes the brand name, lens measurements, and an expiration date. But don’t expect your eye doctor to prescribe anime, or circle, lenses. These bigger-than-normal lenses that give the wearer a wide-eyed, doll-like look have not been approved by FDA.

Buy the lenses from a seller that requires you to provide a prescription, whether you go in person or shop online.

Follow directions for cleaning, disinfecting, and wearing the lenses, and visit your eye doctor for follow-up eye exams.

See your eye doctor right away if you have signs of possible eye infection:

  • redness
  • eye pain that doesn’t go away after a short time
  • decrease in vision

Source: USFDA

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