ePillz.com - Accutane Comes Under the Strengthened Management Program from FDA

Accutane Comes Under the Strengthened Management Program from FDA

On August 12, the Center for Drug Evaluation and Research, which is a subdivision of U.S. Food and Drug Administration (FDA), announced the strengthened risk management program, called iPLEDGE, to enhance the safe use of Isotretinoin (Accutane) for treating the severe forms of acne. The main reason to enforce the precautions and control lays in serious side effects, Accutane can cause when taken by pregnant women or women, preparing to get pregnant. Isotretinoin can cause birth defects, loss of baby or early birth. To avoid this, FDA needs to control that women do not get pregnant for 1 month before starting Isotretinoin treatment, during all period of treatment and 1 month after it.

According to the terms of new program, a centralized registry or clearinghouse will be created with the main task to confirm the negative results of pregnancy test for every female patient, who will need the Isotretinoin treatment. The doctors will be able to prescribe such treatment only after receiving the appropriate confirmation. Moreover iPledge program covers the registering of all patients, taking Accutane, as well as counseling and educating them on the possible risks of the treatment.

Isotretinoin is available under several marketing names, like Accutane, Amnesteem, Claravis or Sotret. At the time being, this is one of the most effective and powerful drug to treat the severe forms of acne, especially nodular acne, which can not be treated with all other methods, including antibiotics. As it is known acne is the skin disease, caused by interaction of hormones on the oil glands of the skin. As the result the skin pores get plugged with too much oil and pimples appear.

It is not only the cosmetic problem, for it can lead to different inflammatory complications, thus it should be medically treated in most cases. Isotretinoin action is in significant decrease of oil amount, produced by oil glands, so that it does not plug up the skin pores and pimples do not appear. It is important to know that Isotretinoin has its advantages and disadvantages in comparison to analogue medicines.

The plus is in its great effectiveness and permanent results. Statistics say that only about 10% of patients experience the return of acne problems during 1 year after Isotretinoin treatment. Most of other acne-controlling medicines are antibacterial agents, which are effective only if the medicine is used daily. At the same time the weak point of Isotretinoin is in its side effects, which can be very serious.

iPledge program is not the first step of FDA to reduce the side effects from Isotretinoin medicines. In year 2004, the similar program, abbreviated as SMART, was implemented. But its effectiveness did not prove the expectations in reducing the pregnancies exposed to Isotretinoin. As the result from now on, the new program iPLEDGE works to ensure the safe treatment with Isotretinoin and to reduce the side effects appearance.