In 2004, women using the Ortho Evra contraceptive patch were three times as likely as women using birth control pills to die or develop nonfatal blood clots, according to FDA reports obtained by the Associated Press under the Freedom of Information Act, the AP/Yahoo! News reports (Mendoza, AP/Yahoo! News, 7/17). The patch, which is manufactured by Johnson & Johnson's Ortho-McNeil and first became available in the U.S. in April 2002, is worn on the skin for one week at a time, delivering to the bloodstream progestin and estrogen, the same synthetic hormones used in birth control pills (Kaiser Daily Reproductive Health Report, 9/22/04). After receiving permission from FDA to access a database containing about 16,000 reports of adverse reactions to the patch, ranging from rashes to death, the Associated Press reports that about 12 of the estimated 800,000 patch users nationwide died of blood clot-related deaths in 2004 and dozens of other users experienced nonfatal blood clots or strokes last year. FDA and Ortho-McNeil said they are aware of a possible increased risk of blood clots among patch users but added that the patch is as safe as birth control pills, according to the AP/Yahoo! News. Doctors disagree about the importance of the Associated Press' findings and the potential dangers of the patch. Some physicians were alarmed by the number of fatalities and other serious complications from the patch and urged further investigations. Other doctors said some deaths are expected with any medication and no investigation is needed, adding that women should not overreact to the news and remove the patch because unintended pregnancy could be more risky (AP/Yahoo! News, 7/17).

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Ortho-McNeil earlier this year launched a new study of the deaths and serious side effects related to using the patch. In addition, Johnson & Johnson in March launched print and television advertisements for Ortho Evra featuring doctors who discuss risks associated with the contraceptive patch, including blood clots and strokes. Johnson & Johnson CEO William Weldon said he approved the ads because drug ads generally "may inadvertently minimize the importance and power of medicines and their risks," adding, "Our communication with consumers should be thought of as direct-to-consumer education." However, the study and ad campaign are not in response to recent reports of deaths associated with the patch, according to Katherine LaGuardia of Ortho-McNeil (Mendoza, AP/Yahoo! News, 7/16).