Wednesday, June 25, 2014

Fwd: FDA MedWatch - Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions

---------- Forwarded message ----------
From: FDA MedWatch <fda@service.govdelivery.com>
Date: Wed, Jun 25, 2014 at 10:20 AM
Subject: FDA MedWatch - Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions
To: iammejtm@gmail.com

Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions

Sold under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.

AUDIENCE: Consumer, Pharmacy, Family Practice

ISSUE: FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use.

These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels.

The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

BACKGROUND: Based on the information reported to FDA, it cannot be determined if the serious hypersensitivity reactions were triggered by the acne products' active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both. FDA is continuing to monitor and evaluate this safety issue, and will work with manufacturers regarding any future label changes that would address the risk of severe hypersensitivity reactions.

RECOMMENDATION: Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don't develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402722.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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This email was sent to iammejtm@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

--
Jeremy Tobias Matthews

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Riding Of The Practical Knowledge Through The Moves Done Up Ahead; Up River In The Visualization Of River Boarder Moves Being Done. One Should Fit The Shape That's Going To Steer Through The Rapids Accurately In Order To Make The Sport Safer And Better. It Is True That This Sport Is Beyond All Of Us Inspiring All Of Us River Boarders To Champion The Charge Up River In The Uplifting Of The Human Spirit, Therefore To Instance Such Self Reliance In Action By Shaping And Self Propelling In Roaring Rapids That Are Deep Enough Where The Rider's Wise Enough To Navigate With Some Custom Steering Edges By A River Boarder Capable Of Eyeing The Spot To Ride In. The Set Up Should Also Be Customized For Each Spot The Rider Is Going To Ride In. Any One Size Fits All Is Inaccurate When Dealing With Multiple Gaps Of A Set Of Rapids With Skimming Spaces On Either Side Wherefore Knowing Where All Of The Rocks Are At Is As Important As Is Where To Mix And Match The Handle System, The Board And Set Up To Fit What Gap In The Rapids You Want To Start From In The Ride Up River. All Shapes Are Available In Foam Composite Or Wood, Just Tell Me Which Shape As Well As Color Of Edges, Background, What Creature and Color Of It.

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The Art Of The Stretch System Is To Get The Stretch The Same Consistency As The Current To Ride In So The Rider Is In Balance With The River. This Is A Lot Less Strain On The Body. It Also Makes For A Smooth Even Pull Up River With No Jerks Or Sudden Stops. Since Every Riding Spot Is Different The Professional Rider Has Different Length Segments To Match Different Spots. Therefore For The Safety Of Customers The Rider Should Know How Many Gaps They Want To Charge Up Into And How Deep The Water Is. The Shop Rate For Making A Set Up Is $40 An Hour Tie Off Instructions Included With Purchase. Please Set An Appointment For Estimate.

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A4 Description

Overall This One Is Shaped Like An Otter However This One Does Have A Tendency To Get Caught In A Dive If The Rider's Weight Is Not Kept On The Back End To Prevent The Current From Taking The Nose To The Bottom So The Rider Must Adjust When Caught In a Dive. Don't Just Let It Go. You Will Just Have To swim To The bottom To Get It Anyway. You Might As Well Adjust Right Then And There And Put Weight On The Back End Of The Board While Your Exploring Underneath The River. It Does Have A Split Tail On The Rear Which Makes For Nice Rail To Rail Banking. It Also Has The Inverted Center So You Can Carry It Under Your Arm Like A SurfBoard With The Same Length As A3.

A5 Description

One Of The Things I Love About This Shape Is The Diversity Of Tricks It Allows. A Skilled Rider Can Do Any Trick On Any Shape Granted, But Some Tricks As A Shaper Has A Certain Shape In Mind, Just Work Better For Those Tricks. That Is Why A Good Shaper Rides The Boards They Make And Visualizes The Moves They Will Do Within The Movement And Bodily Timing With The Rapids Before They Make The Shape They Ride And So This Is The One That This Rider Can Do The Most Tricks Under The Water, On The Water And Above The Water With To Begin With, And Then Once The Tricks Are Mastered They Can Be Done On Any Board. Some Boards Will Work Better For Different Body Types So Knowing Your Own Body Is The first Step And Knowing The Tricks And Spot Come Next. Trust Yourself You Will Always Do That The Best.

Wednesday, June 25, 2014

Fwd: FDA MedWatch - Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions

Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions

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