March 97 Medical Bulletin

FDA Medical Bulletin * March 1997 * Volume 27 Number 1

NOTICES

Fertility Drug Shortage Over

A shortage beginning in early 1995 in the United States of 2 fertility drugs, menotropins and urofollitropin (Pergonal and Metrodin, both manufactured by Serono Laboratories Inc, Norwell, Mass), has been alleviated. With adequate supply of those drugs and FDA approval of other fertility drug products, the FDA is recommending to physicians that they start patients on the available approved fertility drugs. The FDA is also recommending that physicians inform patients now receiving their drugs from alternative sources that they will no longer be able to acquire fertility medications from non-US sources. During the period of the shortage, the agency had used its enforcement discretion to permit women to import fertility drug products for their personal use from non-US sources if their physicians could not obtain sufficiant US supplies. The agency will be directing its field offices to begin the process of no longer allowing the release of unapproved, imported fertility drug products.

FDA Calls for Applications for Emergency Use of Oral Contraceptives

FDA has published a Federal Register notice requesting that manufacturers submit supplemental new drug applications for emergency use of oral contraceptives. This use of oral contraceptives, known as emergency contraception, is intended to prevent unintended pregnancy in women who have had unprotected sexual intercourse. Oral contraceptives used for this purpose are often referred to as the morning after pill.

The Agency issued this notice because it concluded, on the basis of current scientific evidence, that certain oral contraceptives approved for daily use are safe and effective as emergency contraceptive pills. Approval of this indication would allow information on appropriate treatment regimens to be added to the labeling for physicians and patients alike.

Oral contraceptives were first approved in the 1960's. Although many versions of the oral contraceptives containing an estrogen and progestin are available in the United States, no sponsor has submitted a new drug application for use of these products as emergency contraceptives. As a result, no oral contraceptives are labeled or promoted for emergency use although individual physicians may prescribe them for this purpose as part of their medical practice.

Numerous studies have shown that specific regimens consisting of higher doses of oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel can be used to prevent conception when other contraceptives fail or when no contraception is used. At a June 28, 1996, meeting of the Agency's Reproductive Health Drugs Advisory Committee, the committee unanimously concluded that four specific treatment regimens are safe and effective. Further details are provided in the Federal Register notice.

Although emergency contraception is not as effective as proper use of a regular contraceptive method, it substantially reduces the chances of becoming pregnant after unprotected sexual intercourse. Risks, contraindications, and warnings for the emergency use of an oral contraceptive would be similar to those for oral contraceptives prescribed for daily use. About half the women who take the emergency contraceptive regimen have temporary nausea.

In the Federal Register notice published February 25, 1997, the Agency said that it is prepared to accept applications based on the available evidence.

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