The contraceptive patch Ortho-Evra exposes women to dangerous levels of the hormone estrogen, posing a possible two-fold increase in the risk of blood clots, and should be removed from the market within six months, Public Citizen (Washington) told the FDA in a petition. Ongoing litigation has recently released unpublished studies that confirm the increased estrogen content of the patch.

Evidence compiled by Public Citizen's Health Research Group indicates that, compared to standard oral contraceptives, Ortho-Evra exposes women to:

More estrogen and a greater range of estrogen levels.

A possible two-fold increase in the risk of blood clots.

Increased painful side effects such as breast discomfort, severe menstrual pain, nausea and vomiting.

An increased likelihood of discontinued contraceptive use.

No improvement in contraceptive outcomes.

Ortho-Evra patches are designed to be worn on the skin for seven consecutive days before removal. Three consecutive patches are worn followed by a patch-free week. When Johnson & Johnson (New Brunswick, New Jersey) received FDA approval in November 2001 for marketing the patch, the company said that its product would have two key advantages over existing oral contraceptives: 1) A constant delivery of hormones instead of the ups and downs associated with pill use, and 2) improvements in compliance compared to the daily dosing regimen of oral contraceptives.

However, Public Citizen said "evidence soon emerged that these theoretical benefits are outweighed by side effects from receiving high and variable levels of hormone exposure."

The group said a post-market study was the basis for a 2005 label change explaining that overall exposure to estrogen from the Ortho-Evra patch was 55% to 60% higher from the patch than a standard 35 mcg estrogen oral contraceptive. Comparison studies also have shown that the amount of absorbed estrogen varied 1.2 to 3.5 times as much for women who used the patch than women who used oral contraceptives.

"Had Ortho-Evra been designed as a pill, it is unlikely to have been approved because of its increased estrogen content," said Sidney Wolfe, MD, director of the Health Research Group at Public Citizen.

The Ortho-Evra label was changed again in 2006 and 2008 to include findings from studies that revealed an up to two-fold increase in the risk of blood clots in women using the patch compared to standard oral contraceptives. Further, side effects (such as breast discomfort, painful periods, nausea and vomiting) and discontinuation (stopping the contraceptive entirely) due to side effects were more common among women who used the patch compared to those who used pills.

Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

AACE praises FDA efforts with insulin pumps

The American Association of Clinical Endocrinologists (Jacksonville, Florida) applauds the FDA's efforts to protect the safety of children and adolescents who are using insulin pumps," said Richard Hellman, MD, the Association's president.

In the May edition of Pediatrics, Judith Cope, MD, a physician at the FDA, provided new data that shows there is a serious problem regarding patient safety in insulin pump use. She reported data on 1594 injuries and 13 deaths in children and adolescents collected over 10 years; 82% of the cases resulted in hospitalization. The most common single issue was lack of education, and neither the patient nor the responsible adult knew enough about how the pump worked to avoid the injury or death that resulted. Although there were some cases due to mechanical malfunction of the pump, most problems were the result of human factors involved in the use of the pumps.

Unfortunately, the FDA has not yet provided similar data regarding the numbers of serious injuries in the larger group of pump users, adults who are using insulin pumps.

Hellman said that the American Association of Clinical Endocrinologists has an annual program, now in its third year, to teach and provide hands-on experience to all physicians completing specialized training in endocrinology. They are taught how to care for patients on insulin pumps, how to protect them from harm due to pump malfunction, and how to improve their patient's skills in using an insulin pump safely and well. The physicians find the program most valuable, but more such programs are needed. "This past year we appointed a task force of pump experts to develop guidelines and standards for initiating pump use and what we consider essential to provide for the safe and effective medical care of those on insulin pumps."