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Johnson & Johnson, the makers of the Ortho Evra (norelgestromin/ethinyl estradiol) birth control patch, has updated the drug’s warning label to include new data on the odds ratio estimates of venous thromboembolism risk in women on Ortho Evra compared to users of oral contraceptives. The new label was approved by the Food and Drug Administration (FDA).
Alisha Gutcher was just 24 years old when she suffered from chest pains and lightheadedness. “My heart was just freaking out,” she said to the Sault Star. “You could see it jumping in my chest.” When she phoned a friend and complained that she couldn’t breathe, her friend took action, driving her to the emergency room where she was immediately admitted. Doctors told her that blood clots had formed in her lungs (pulmonary embolism) and leg (deep vein thrombosis), and she was on the verge of dying. But what would cause an otherwise healthy young woman to become so seriously ill? Doctors confirmed, it was her birth control patch.
Leslie Niedner can’t make sense of the death of her 17-year-old daughter Adrianna. She was a healthy and active college freshman. It was later revealed that what killed her was a blood clot in her lung, also known as a pulmonary embolism. But how could such a condition happen to someone so young and healthy?
The Ortho Evra birth control patch has updated the CONTRAINDICTATIONS, WARNINGS and ADVERSE REACTIONS sections on its label and packaging, according to the Food and Drug Administration’s MedWatch July 2009 Drug Safety Labeling Changes posting. Ortho Evra was one of 38 drugs listed in the report.
A patch-delivery system is now available to consumers who want or need more of the vitamin B-12, an essential vitamin that plays a key role in the normal functioning of the brain and nervous system and for the formation of blood. B-12 is naturally found in meat, shellfish, milk, eggs and fortified cereals, but many people’s digestive systems do not absorb enough B-12, which can lead to vitamin B-12 deficiency. A B-12 deficiency can contribute to anemia, which can leave you feeling weak, lightheaded, depressed and tired.
More than 40 drug development programs have transdermal systems, or drug patches, under development for either initial approval or expanded indications, according to Pharma Live. But can consumers trust their safety record?
Canadian pharmaceutical company Janssen-Ortho, Inc. in cooperation with Health Canada has issued a press release updating information on the average daily release rates of contraceptive hormones from the EVRA Transdermal Contraceptive System (patch) that is marketed in Canada and approved for use for the prevention of pregnancy. EVRA is bioequivalent to Ortho Evra, the birth control patch that is marketed in the United States.
A new provision in the proposed budget signed by President Barack Obama last week could help significantly reduce the cost of birth control for young women by allowing pharmaceutical companies to reinstate discounts on contraceptives that they had previously offered to family planning clinics.
A new program in Wayne County, Michigan, is giving financially strapped women access to free family planning services, health care and birth control. However, women should be advised to consider their birth control options even if they come at no cost.
Johnson & Johnson, the makers of the Ortho Evra contraceptive patch for women, has agreed to settle lawsuits filed by Canadian women who suffered from blood clots, heart attacks or strokes after using the patch. The drug maker avoided trial by spending more than $68 million to settle similar claims by women in the United States, according to Bloomberg.
