Trade nameOrtho evra patch Generic namenorelgestromin ethinyl estradiol By: Tiffany Skillern and Shalynn Spikes January 21, 2010 Mrs. Holmes[ best teacher alive] 1st pd
Years on the market • Ortho Evra birth control patch introduced on the market in April 2002. • Knowing how dangerous the patch was, the FDA approved it and the drug companymarketed it without adequate warnings • The patch spent 8 years on the market. • 44 serious blood-clot related injuries were reported in the first year. • At least 29 women, most in their late teens and 20's, have died as a result of using the patch. • The Ortho Evra patch is manufactured by Ortho McNeil Pharmaceutical, Inc. based in Raritan, New Jersey.
What is ortho evra patch • The Patch is birth control that you wear on your body. It is a small, beige, thin, smooth, square-shaped patch with rounded edges that helps prevent pregnancy the same way the birth control pill does. • The medicine is delivered into the bloodstream through transdermal, or "through the skin," technology, instead of by traditional oral means. • The Patch is worn on the body, preventing pregnancy by delivering continuous levels of hormones (progestin and estrogen, respectively) into the bloodstream through the skin. Following this process, the Patch works the same way that pills do: by preventing ovulation. • This means that the ovary does not release an egg to be fertilized. It also thickens the cervical mucus, which makes it more difficult for sperm to enter the uterus, and it changes the endometrium, which is the mucus membrane that lines the uterus, to reduce the chance of implantation..
What are the side effects? • Thrombophlebitis and venous thrombosis with or without embolism • Arterial thromboembolism • Pulmonary embolism • Myocardial infarction • Cerebral hemorrhage • Cerebral thrombosis • Hypertension • Gallbladder disease • Hepatic adenomas or benign liver tumors • In addition to these common side effects, serious risks, which can be life threatening include, blood clots, stroke and heart attacks, and are increased when you smoke cigarettes, especially if you are over 35. • breast symptoms, which included pain, tenderness and swelling. Headache, nausea, upper respiratory infection, menstrual cramps and abdominal pain were also experienced. Skin irritation and rash were also reported at site of application.
Process to get it off the market • Its first 2 years on the market, at least 17 young women between the ages of 17 and 30 died after using the Ortho Evra patch. The following year, in 2004, 12 more young women died after using the patch. All of them died from blood-clot related injuries. Most of them were in their late teens and early twenties. Dozens more survived strokes and other blood-clot related injuries during that time period • Results were 1st group said results were similar to those of women taking an oral contraceptive; 2nd group said those with patch were 2 times more likely to suffer from blood clots
FDA APPROVED? SAY WHAT? • On November 10, 2005, 3 ½ years after Ortho Evra was approved, the FDA and Ortho McNeil Pharmaceutical issued a warning to healthcare providers and revised the warning label on the Ortho Evra Patch. • The warning states that women who use the patch are exposed to approximately 60% more estrogen than women who use an average birth control pill. • Estrogen is the hormone that is known to cause blood clots. Following is an excerpt from the FDA. • According to Associated Press reports, the FDA and Ortho McNeil Pharmaceutical were aware of this increased risk before the drug was even approved. • The dangerous elevated risk was noted by the FDA physician who reviewed the drug before the agency approved it. • The reviewer said "the label should clearly reflect this reviewer's safety concern about a potential increased risk." He added that it would be important to study users of the patch for blood clot injuries after the patch was on the market.
Prevention and precautions • FDA should have checked label; although label had risk it was the exact same label from that of the oral contraceptives • Knowing how dangerous the patch was, the FDA approved it and the drug company marketed it without adequate warnings • In 2005, after investigative reporters published the true risks, a warning was added to the label • To date, the Ortho Evra patch has not been recalled and is still being marketed aggressively to young women across the United States and in other parts of the world.
Producers • Shalynn Spikes • Tiffany Skillern