Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Acne Health Center

Font Size

FDA Panel: Ease Accutane Rules

Flexibility Urged in Program to Prevent Birth Defects From Acne Drug
WebMD Health News
Reviewed by Louise Chang, MD

Aug. 1, 2007 - A program to prevent birth defects from the acne drug Accutane should be more flexible, an FDA advisory panel said today.

Accutane is a powerful drug that works against some of the hardest-to-treat forms of acne. But the drug also causes birth defects. Women who take the drug must take careful steps to avoid pregnancy.

FDA approval of Accutane requires all patients taking the drug to register with the so-called iPledge program. The program is designed to ensure that patients avoid pregnancy, and links prescriptions to pregnancy tests.

Even so, 122 women taking Accutane (or other versions of the drug generically known as isotretinoin) became pregnant during the first year of the program.

The FDA convened an expert panel to review the iPledge program and to make recommendations on how it might be improved.

The panel today voted to make the program more flexible, to take steps to reduce treatment interruptions, and to reduce unnecessary burdens for patients, an FDA spokesperson tells WebMD.

The panel recommended two major changes to the iPledge program:

  • Currently, the program requires women to fill their isotretinoin prescriptions within seven days of the office visit at which they received the prescription. The panel recommended starting the seven-day clock at the time of a pregnancy test.
  • If a patient fails to fill a prescription within the seven-day window, current rules require the patient to wait 23 days before the prescription can be filled. The panel recommended that a new seven-day window can begin on the date of a new pregnancy test.

FDA panel recommendations are not binding, although the agency almost always follows the advice of its panels.

Today on WebMD

Girl with acne
See if you know how to control your acne.
happy woman with clear skin
Triggers and treatments for blackheads, whiteheads, and cystic acne.
Bride with acne
Dos and don’ts for hiding breakouts.
close-up of a young man soaping his face
Why adults get acne and how to treat it.
Boy cleaning acne face
HPV Vaccine Future
beauty cream
Bride with acne
Woman applying mineral makeup
Arrows pointing on teen girl blemish

WebMD Special Sections