Birth Control Patch

Side effects of Ortho Evra among the most commonly misdiagnosed

admin — Mon, 23 Aug 2010 16:40:21 +0000

A November 2009 study published in the Archives of Internal Medicine has found that a number of side effects linked to the Ortho Evra patch are among the most commonly missed or delayed diagnoses by physicians. A survey of more than 300 physicians found that cases of pulmonary embolism and stroke frequently resulted in diagnostic errors due to mistakes in assessing patients or other factors.

The Ortho Evra birth control patch has been linked to a number of serious and potentially deadly side effects, including blood clots, deep vein thrombosis, pulmonary embolism, heart attack and stroke. In 2006, the Food and Drug Administration issued a warning to Ortho Evra users after a study revealed that the birth control patch was twice as likely to cause blood clots as birth control pills.

The consumers group Public Citizen has called on the FDA to take Ortho Evra off of the market, citing the risk of blood clots and other side effects faced by users of the birth control patch. Despite these efforts, the FDA has yet to announce plans to issue an Ortho Evra recall.

Side effects of Ortho Evra among the most commonly misdiagnosed

admin — Mon, 09 Nov 2009 15:10:06 +0000

A new study published in the Archives of Internal Medicine has found that a number of conditions linked to the use of the Ortho Evra patch are commonly overlooked by physicians. A survey of more than 300 physicians found that pulmonary embolisms and strokes were frequently misdiagnosed due to mistakes in assessing patients or other factors.

The consumers group Public Citizen has called on the FDA to take Ortho Evra off of the market, citing the risk of blood clots and other side effects faced by users of the birth control patch. In spite of these efforts, the FDA has yet to announce plans to issue an Ortho Evra recall.

FDA approves new Ortho Evra patch warning

admin — Tue, 01 Sep 2009 18:53:50 +0000

The Food and Drug Administration has approved new labeling changes to the Ortho Evra birth control patch intended to warn users about an increased risk of blood clots and other side effects. According to the new warning, women who use the Ortho Evra patch may be more than twice as likely to suffer serious blood clots as women who are using birth control pills.

The new FDA warning was based on the results of several studies which examined the potential link between Ortho Evra and blood clots or other side effects. Other studies have also found that women who use the Ortho Evra patch may double their risk of blood clots. These clots can increase the risk of other serious side effects, including heart attack, stroke or pulmonary embolism.

More than 4,000 women who used Ortho Evra have filed lawsuits against the manufacturers of the birth control patch, alleging that they concealed information about its safety from consumers. Because the Ortho Evra patch releases about 60% more estrogen into the body than birth control pills, these women allege that they were unwittingly exposed to an increased risk of deep-vein thrombosis or other conditions.

Still no Ortho Evra recall from FDA despite group’s call for action

admin — Mon, 01 Jun 2009 16:20:54 +0000

The Ortho Evra patch is still on the market more than one year after a leading consumer advocacy group called on the Food and Drug Administration to issue a recall for the birth control patch. The Public Citizen Health Research Group petitioned the FDA in May 2008 to issue an Ortho Evra recall, citing the increased risk of blood clots and other side effects that that could face women who are use the patch.

Because the Ortho Evra patch delivers about 60% more estrogen into the blood stream than birth control pills, women who use the patch are approximately twice as likely to develop blood clots, including deep vein thrombosis. These blood clots in the legs or other parts of the body could travel to the lungs, leading to a pulmonary embolism.

Although Ortho Evra is still on the market, many women have stopped using the birth control patch due to the risk of side effects they may face. Despite this fact, more than 2.7 million Ortho Evra prescriptions were filled in 2007 alone.

While the FDA has not yet issued a recall on Ortho Evra in response to Public Citizen’s petition, the agency has taken action following previous petitions from the group. In August 2006, Public Citizen petitioned the FDA to issue a black box warning to alert users of Levaquin and other antibiotics of a potential risk of ruptured tendons. The agency added warnings in July 2008 after Public Citizen filed a lawsuit against the FDA.

Similarly, Public Citizen petitioned the FDA to strengthen warnings about Botox that the toxin could spread from the injection site, causing potentially life threatening side effects. The FDA added a black box Botox warning in April 2009.

FDA has not heeded group’s petition for Ortho Evra recall

admin — Sun, 10 May 2009 20:02:01 +0000

More than one year after the consumer advocacy group Public Citizen called on the Food and Drug Administration to issue a recall of the Ortho Evra birth control patch, the agency has yet to take any publicized action in response. Many women continue to use Ortho Evra—including about 2.7 million prescriptions as recently as 2007—despite the group’s call to withdraw the patch.

Public Citizen’s petition in May 2008 called on the FDA to remove the patch from the market within six months due to an increased risk of side effects compared with other birth control products. Because the Ortho Evra patch releases about 60% more estrogen into the bloodstream than birth control pills, women who use the patch are about twice as likely to experience serious blood clots as with the pill.

Although the FDA has heeded previous petitions from Public Citizen, it has sometimes taken them a year or long to take action. In August 2006, the group petitioned the FDA to issue a “black box” warning about the risk of tendon ruptures with Levaquin and other antibiotics, which the agency finally did almost two years later in July 2006.

Similarly, in January 2008, Public Citizen called for warnings about the risk of serious side effects from Botox, including potentially life-threatening swelling, breathing or swallowing problems. The FDA issued a black box warning about Botox in April 2009.