Roche reports progress in Accutane warning program - Hoffmann-La Roche Inc

FDA Consumer, Sept, 1991

Roche Reorts Progress in Accutane Warning Program

A campaign designed to emphasize the danger of birth defects with the prescription drug Accutane (isotretinoin) appears to be working, according to the drug's manufacturer, Hoffmann-La Roche Inc. of Nutley, N.J. However, FDA emphasizes that it is important to make sure that women who are pregnant or who may become pregnant do not take the drug.

The program, Pregnancy Prevention Program for Women on Accutane, was developed by the Roche Dermatologics Division in cooperation with FDA, in response to reports of severe birth defects associated with use of the drug.

Estimates indicate that the number of women aged 12 to 44 who begin taking Accutane has declined steadily, from 95,000 new patients in 1985 to 57,000 in 1990. Since Roche began the program, in November 1988, approximately 20 percent of women evaluated for Accutane treatment using the program kit have been disqualified for therapy.

Accutane has carried a pregnancy warning since it was approved in 1982 for severe, recalcitrant acne, a serious and debilitating condition that causes cysts, scarring and disfigurement. The original labeling warned physicians the drug should not be used by pregnant women or women who might become pregnant. Nevertheless, as early as 1983 there were reports of birth defects associated with use of the drug, and both FDA and the manufacturer addressed the problem with labeling revisions and educational campaigns.

Key components of the Pregnancy Prevention Program for Women on Accutane include:

* revised information for physicians listing six conditions that are prerequisites for use of Accutane by women of childbearing age

* a follow-up survey by the Boston University School of Public Health on women using Accutane

* kits sent to health-care professionals, particularly dermatologists, to aid them in determining which patients should be treated with Accutane

* revised product packaging emphasizing the necessary steps a woman must take to ensure she is not pregnant before beginning treatment with Accutane and that she does not become pregnant while taking it

* an offer by the manufacturer to pay for pretreatment contraception counseling and an initial pregnancy test

* extensive educational programs on the Accutane pregnancy warning.

Although there appears to be progress toward reaching educational goals, FDA warns that physicians and consumers need to strictly adhere to the conditions under which Accutane may be given to women of child-bearing potential, if exposure during pregnancy and birth defects are to be avoided.

Tamperer Sentenced

A North Carolina woman who put slivers of glass in her baby's food and told FDA investigators she found them there when she opened the jar was sentenced on June 13 in the U.S. District Court in Greensboro, N.C.

The court ordered Sherry Lynn Pate of Sophia, N.C., to pay $3,500 restitution to the Harris-Teeter grocery store chain. In November 1989, Harris-Teeter pulled all Gerber Strained Garden Vegetables out of its stores in the Southeast after Pate told the company and the media she had found glass slivers in that brand. Pate was also ordered to undergo psychiatric counseling, pay a $50 special assessment fee, and serve five years' probation.

Pate told FDA investigators she put the glass in her daughter's food to get the attention of her husband, a High Point, N.C., police officer. She did not feed the food to her baby, and she later confessed to the tampering (see "Tampering for Attention" in the July-August 1991 issue of FDA Consumer).

Her actions were in violation of the Federal Anti-Tampering Act, which, among other things, prohibits lying to federal officials about tampering with a consumer product.

Medication for Genital Warts

The first prescription medication for genital warts that patients can apply themselves was approved by FDA on Dec. 13, 1990.

All other approved treatments for this sexually transmitted disease, which yearly affects an estimated 8 million Americans, must be administered by a physician.

Under the approved course of treatment, patients apply the medication, Condylox (podofilox), to the warts with a cotton swab twice a day for three days, followed by four days with no treatment. That cycle can be repeated for up to four weeks, if necessary, to clear up the warts.

However, Condylox is not a cure for the human papilloma virus (HPV), which causes the warts. Therefore, the warts may reappear.

In clinical trials, about half of the 70 patients had no warts after four weeks of treatment. However, two weeks after treatment was stopped, warts had recurred in half of those patients who had been wart-free.

Current treatment guidelines recommend stopping treatment with Condylox after four weeks. The safety and efficacy of continuous use is still under study.

* Other therapies available to treat genital warts include:

* freezing, burning or laser surgery

* injecting a form of alpha interferon directly into the warts.

The Mayapple (Podophyllum peltatum), a wildflower found in eastern North America, is the source for Condylox's active ingredient, podofilox. (For more information on drugs from plants, see "Harvesting Drugs from Plants" in the October 1990 FDA Consumer.)