New Accutane Requirements - Answering Service Resources

Home
>
Acne
>
New Accutane Requirements

New Accutane Requirements

Starting January 1, 2006 people with severe acne who need Accutane (isotretinoin), must enroll in the FDA's new iPLEDGE program through a physician who is also enrolled.

In an effort to reduce the number of birth defects caused by isotretinoin, these new rules require anyone involved in the use or distribution of Accutane to be registered in iPLEDGE and to abide by its reporting requirements.

Specifically, users of Accutane (or any other drug containing isotretinoin) must do the following:

Everyone:

* must be registered in iPLEDGE by your doctor, who must also be registered.

* must understand that severe birth defects can occur with use of isotretinoin by a female who could become pregnant.

* must receive and read educational materials with safety information about isotretinoin and about iPLEDGE program requirements.

* must sign an Informed Consent form that contains warnings about the risks of isotretinoin.

* must fill your prescription for isotretinoin within 7 days of your doctor visit.

* must agree to see your doctor every month during treatment for a progress check-up and to get a new prescription for isotretinoin.

Women of childbearing age, in addition:

* must not be pregnant or breast-feeding.

* must have 2 negative pregnancy tests before starting isotretinoin, a negative pregnancy test every month during treatment, and a negative pregnancy test 1 month after treatment has ended.

* must use 2 different forms of birth control at all times unless you agree not to have heterosexual intercourse for 1 month before isotretinoin treatment, during treatment, and for 1 month after treatment has ended.

* must sign a second Informed Consent form with warnings about the risks of birth defects if pregnancy occurs before or during isotretinoin treatment.

* must access the iPLEDGE program on the Internet or by telephone before starting isotretinoin, once a month during treatment, and 1 month after ending treatment to answer questions about program requirements and to enter the 2 forms of birth control you have chosen.

The above is not a complete listing of program requirements.

For more information, visit www.ipledgeprogram.com or telephone 1-866-495-0654.

Visit Ron's website Latest-Acne-Solutions for the lastest research into acne relief.

In The News:

Yaz Is Not A Miracle Drug
The Frisky, Georgia - 11 hours ago
Similarly, Yaz is approved for the treatment of moderate acne, but the FDA said the ad suggests it is approved for acne of all severities. ...

Teens face increased acne concerns this time of year
nwitimes.com, IN - Oct 8, 2008
But according to Dr. Hilary Baldwin, dermatologist and president of the American Acne and Rosacea Society, lifestyle changes and new products can help young ...

Deccan Herald
Look back in pride!
Deccan Herald, India - 12 hours ago
Sometimes, an acne condition can spread to the shoulders and back. In such cases, it is better to use medicated and specialised products to control the ...

Acne Myths
ABC 4, Salt Lake City - Oct 8, 2008
Acne – a four letter word we all dread. But as much as we don’t like to talk about this condition, 50% of adult women and 25% of all adult men get it ...

New Acne Fixes You Might Not Have Considered
Times of the Internet, Ohio - Oct 7, 2008
Everyone is looking for the best acne fixes for dealing with their skin as acne can be a demoralizing affliction at any age. It's important to keep in mind ...

Pressemeldungen.at (Pressemitteilung)
Best Acne Treatment Using Nature’s Cure for Acne
Pressemeldungen.at (Pressemitteilung), Austria - Oct 7, 2008
Acne is a skin condition which can bring anyone who is effected down in self esteem. Acne is hard to ignore especially when your skin is covered with ...

Eisai Introduces "Chocola BBR Drink bit", New Pharmaceutical Drink ...
Japan Corporate News (press release), Japan - Oct 7, 2008
"Chocola BBR Drink bit" is an over-the-counter pharmaceutical product for acne and skin care available in drink form. It alleviates skin problems with its ...

Is it safe to use acne face wash on a newborn?
SouthCoastToday.com, MA - Oct 7, 2008
Is it safe to use a face wash for acne on a child? Based on your description, it sounds like your daughter has milia. Milia are small white spots under the ...

PR Web (press release)
Mario Badescu's Drying Lotion: The Original Pink Acne Treatment is ...
PR Web (press release), WA - Oct 7, 2008
Many recent editorial mentions in magazines such as Elle, OK, and Women's Day show that it is still on the forefront in the battle against acne. ...

FDA issues warning letter over Yaz DTC ads
FiercePharma, DC - Oct 8, 2008
Yaz is in fact approved for treating "moderate acne vulgarities," as well as premenstrual dysphoric disorder (PMDD)--a more severe condition that causes ...
Bayer to Pull Yaz Ad After FDA Warning AdAge.com (subscription)
FDA cites Bayer for misleading birth control ads Reuters
FDA Warns Bayer AG about Misleading Ads Featuring Birth Control ... Network Médica
Pharmalot - Newsinferno.comall 21 news articles

acne - Google News

Answering Service ResourceAnswering Service Resource