Ortho-Evra, a patch alternative to traditional birth control pills, was introduced by Ortho-McNeil Pharmaceutical, a subsidiary of drug giant Johnson & Johnson, in 2002. At the time, the drug was hailed as a safe, easy to use alternative to birth control pills.
Ortho Evra Patch VS. Birth Control Pills
According the FDA’s press release announcing Ortho-Evra, “[t]he risks of using this product are similar to the risks of using birth control pills including an increased risk of blood clots, heart attack, and stroke.”
Since that press release was issued, however, evidence has come to light that not only are the risks of the patch far greater than those of birth control pills, but both Ortho-McNeil and the FDA were aware of the greater incidence of problems with the patch, and did nothing to warn patients or their doctors of these increased risks.
In fact, the Ortho Evra patch exposes women to 60% more of the hormone estrogen than regular birth control pills, and Ortho Evra users are three times as likely as traditional birth control pill users to suffer blood clots while on the medication. The data this information is based on was the original data supplied to the FDA by Ortho-McNeil Pharmaceutical when seeking approval for Ortho Evra.
It was not, however, until 2005 that a third party analyzed the data and publicized this disturbing incidence of problems. By that time, as many as 23 women and girls had already died as a result of their use of Ortho Evra.
In addition to the existing data based on Ortho-McNeil’s own clinical trials, even more disturbing evidence has come to light since.
During the same time frame beginning in May 2002, the FDA received 44 reports of blood clots, including some fatal, caused by use of the Ortho Evra patch. The Johnson & Johnson Ortho Tri-Cyclen birth control pill was only responsible for 17 cases of blood clots, even though the pill was being used by almost six times as many people as the patch was.
During litigation over the safety of the Ortho Evra patch, Ortho-McNeil’s internal records were introduced, showing that the drug company had received 500 reports of serious health problems caused by the patch. During the same time frame, they had received only 61 reports of health problems associated with all birth control pills.
Dangerous Side Effects of Ortho Evra
While the side effects of the Ortho Evra patch are similar to the side effects of birth control pills, the primary distinction between the two is that problems are far more frequent with the Ortho Evra patch than they are with traditional pills.
The most frequent serious side effect of the Ortho Evra patch is the development of blood clots and other severe cardiovascular problems. These blood clots can appear even in young, otherwise healthy women, who were never at risk of blood clots before using the Ortho Evra patch.
Based on this data, and on other cases of side effects that have been confirmed, the risk of blood clots with the Ortho Evra patch is estimated to be fourteen times greater than the risk with traditional birth control pills.
Some of the most common symptoms of a blood clot are:
- Nausea and vomiting
- Problems with vision
- Severe headaches
If you or someone you know is currently using the Ortho Evra patch, it is important that you understand the risks involved, and that you are familiar with the symptoms of serious side effects, as these can be deadly. If an Ortho Evra user begins to exhibit these symptoms, seek emergency medical attention immediately.
If You’ve Been Injured
If you or someone you love has suffered a blood clot, stroke, or other cardiovascular problem while using the Ortho Evra patch, you deserve compensation for your injuries, particularly if you and your doctor were not sufficiently warned of the potential risks involved.
Ortho-McNeil Pharmaceutical chose to ignore the serious dangers this product would cause its users, and now that those risks have become known, the women who have been hurt by this drug company’s decision have a right to seek compensation for the serious injuries they’ve suffered as a result.
To learn more about how you and your family can go about getting some compensation for your suffering, contact an experienced pharmaceutical injury attorney in your area today.