U.S. Marshals Seize Auralgan Otic Solution (Unapproved FDA Medication)

Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, was being distributed in violation of federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.

On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, the maker of Auralgan, citing the company for distributing unapproved new drugs and misbranded drugs.

As such, on Feb 15, 2011, US Marshals seized all lots of Auralgan Otic Solution warehoused at Integrated Commercialization Solutions Inc. (ICS) in Brooks, KY.

Read the FDA notice here.

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Botox Approved for Migraine Headaches in the United States

On October 15, 2010, the FDA approved botox for use in migraine headaches. It is hoped that eventually, this procedure will soon be covered by most health insurance companies rather than the few who do so now.

Dr. Chang has been performing botox injections for migraine headaches since 2005 along with for wrinkles, spasmodic dysphonia, cervical dystonias, oral-mandibular dystonias, etc.

Read the NYT article on the FDA approval here.

Read the FDA announcement here.

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UK First Place in the World to Approve Botox for Migraine Headaches

Wall Street Journal reported on July 9, 2010 that the United Kingdom has become the first country in the world to approve botox injections for migraine headaches.

The U.K. approval could shortly precede a decision on migraine treatment from the U.S. Food and Drug Administration.

Botox treatment for migraines can be obtained currently in the US, but is rarely covered by insurance.

Dr. Chang has been performing botox injections for migraines since 2006.

Read the WSJ article here.

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FDA Potentially to Approve Botox for Migraines

As reported in MSNBC today, FDA regulators seem inclined to approve Allergan Inc's wrinkle drug Botox to prevent migraine headaches in millions of Americans, industry analysts said, based on information the drugmaker released on Monday.

That would be great news for current patients of mine who receive botox for migraines. However, once FDA has approved botox for migraines, it may take awhile before it becomes an insurance "covered" procedure.

Read the MSNBC article here.

Read more about botox here.

Dr. Chang provides botox injections for migraine headaches, TMJ, spasmodic dysphonia, torticollis, and other head and neck spastic disorders.

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Sunscreen CAUSES Skin Cancer?!!

On May 24, 2010, a study was released by the Environmental Working Group (EWG) stating that more than half of all popular sunscreens may actually increase the speed at which malignant cells develop and spread skin cancer because they contain vitamin A or its derivatives retinol and retinyl palmitate. In fact only 39 out of more than 500 products examined were considered safe and effective. Tumors and lesions developed up to 21 percent faster in lab animals coated in a vitamin A-laced cream than animals treated with a vitamin-free cream

Other additives cause harm including the hormone-disrupting chemical oxybenzone, which penetrates the skin and enters the bloodstream. Titanium dioxide that is made nanosized may also have serious health implications.

The full list of the best and worst sunscreens can be found on the EWG's searchable database here.

Read a media report here.

As an FYI, a few of the WORST sunscreens are:
• Banana Boat Baby Max Protect, SPF = 100
• iS Clinical SPF 20 Powder & Peter Thomas Roth Instant Mineral Powder SPF 30
• Hawaiian Tropic Baby Creme Lotion SPF 50
• Aveeno Baby Continuous Protection SPF 55
• Anthony Logistics for Men Sunstick SPF 15
• Panama Jack Naturals Baby Sunblock SPF 50
• Banana Boat Ultra Defense Sunscreen Stick SPF 50
• Baby Blanket Tender Scalps Scalp Sunscreen Spray for Babies SPF 45+

For your convenience, a few of the best (and safe) sunscreens are shown here:



The full list of other safe sunscreens can be found here.

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USA Today on Hearing Aids

USA Today on November 2, 2009 published a story entitled "Your Health: Hearing aid guide cuts through the noise" in which best practices for buying a hearing aid is discussed. For the story, Dr. Debara Tucci at Duke University Medical Center was interviewed.

The advice is summarized by an FDA online guide (at fda.gov, click on "medical devices," then "hearing aids") that includes suggestions on how to get your hearing evaluated, how to choose a device and how to get it properly adjusted.

Our practice provides the full spectrum of hearing aid evaluation as well as hearing aid dispensing services (selling, repair, accessories, etc).

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