New FDA Restrictions on Accutane

November 2005, Vol 1 Iss. 2

Accutane is the most effective drug we have to treat acne, but also the most controversial. The media has been irresponsible at times by reporting stories of questionable side effects and in effect “demonizing” this very safe and useful drug. However, the one side effect that is in no way “questionable” is that Accutane can cause birth defects and therefore cannot be given to a woman who may become pregnant. The following is a recent press release issued about the FDA’s new program designed to decrease the number of Accutane pregnancies.New FDA Restrictions on Accutane
UIn an effort to eliminate Accutane-related birth defects, the thousands of Americans who take the acne drug Accutane — and people who prescribe and dispense it — must now enroll in a national registry.

Under the program, every patient — men and women — must enroll in the iPLEDGE computerized registry starting Dec. 31 to receive Accutane or generic versions of the drug isotretinoin. Doctors must register, too, if they wish to continue prescribing the pills. Drugstores and wholesalers also must register in order for the pills’ manufacturers to ship them any supplies.

Additional Steps for Women
Women must undergo two tests to ensure they’re not pregnant in a laboratory or doctor’s office before the initial prescription, and monthly pregnancy testing before each refill. Home pregnancy tests don’t count. The doctor must enter the pregnancy test results into the iPLEDGE system, and the woman must buy her pills within seven days.

These women also must agree to use two forms of birth control while using Accutane, and must self- register on iPLEDGE — in addition to the doctor’s initial registration — to report that they’re doing so. There’s no way to know if women lie in this step, but the FDA sees it as an additional opportunity to warn of the pills’ danger. The last step occurs at the pharmacy. The pharmacist must check the computer database before filling a prescription to ensure that patients followed all these rules.

The Scope of the Problem
The FDA estimates that 100,000 prescriptions for Accutane and generics are filled each month. Since Accutane began selling in 1982, the FDA has reports of well over 2,000 pregnancies among users (and possibly more that were never reported). The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug- caused defects.

Our Experience with Accutane
We have never had a patient become pregnant on Accutane (and Dr. Norman Minars has been prescribing it since 1982). Accutane is a very safe drug and we will continue to prescribe it. There is simply no substitute for the treatment of cystic acne. We have already registered with iPledge. The only difference our patients will notice is more paperwork, because we already require them to be on two forms of birth control and receive monthly pregnancy tests in our office before receiving their prescriptions.
Read about other Acne Treatment Options

Sincerely,
Todd Minars, MD
email: tminars@hotmail.com
phone: 954-987-7512

In This Issue
• New FDA Restrictions on Accutane
• Additional Steps for Women
• The Scope of the Problem
• Our Experience with Accutane
Staff Member Profile
Last month we featured our newest staff member, dermatologist Lesley Clark-Loeser, MD. This month, we feature our “oldest” staff member, Jean Condina.

Jean has worked at Minars Dermatology for over 24 years (now that is a “long-term relationship”). The care with which she does her job and her relationship with patients have played a large part in the success of this practice. She has not been feeling well lately, so we wish her our best and hope to have her back soon.

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