Blood clots and the birth control patch — Blood clots in the leg and blood clots lungs are behind the calls for a recall on the Ortho Evra patch.
Blood clots were the adverse reactions Ortho caused in the lungs of two women given the drug in clinical
trials conducted before the drug was approved and in addition to many similar
cases in women after the drug was marketed.
Adverse reactions ortho evra caused are now in the new warning. The FDA belatedly acknowledges the increased dangers of using
ORTHO EVRA. These adverse reactions were first noted by the FDA physician who reviewed the
drug before the agency approved it.
Despite the adverse ortho reactions that the FDA has now admitted -- that women who use the ORTHO
EVRA birth control patch are exposed to about 60 percent more estrogen than if
they were taking a typical birth control pill, the FDA still allowed the ORTHO
EVRA on the market and is unwilling to ban or recall it.
The problem is that hundreds of pharmaceutical
lobbyists put pressure on the government to keep the drugs on the market.
Birth control is prescribed to young, healthy women and should be associated
with the lowest possible risk of serious adverse drug reactions. There is no
evidence that the ORTHO EVRA birth control patch is a superior contraceptive
compared to older birth control pills.
The Associated Press used the Freedom of Information Act to obtain adverse drug
reaction reports for ORTHO EVRA from the FDA. They reported that in 23 cases
where death was the outcome, doctors found that 17 of the patients’ death
appeared to be blood clot-related, including 12 from last year. The FDA
estimates that it receives reports of only 1 in 10 to 1 in 100 of the serious
adverse drug reactions that actually occur, meaning that the actual rate of
adverse reactions for Ortho Evra may be much higher.
Additionally, the Associated Press looked at the reviews of clinical trial
results done by FDA physicians and scientists prior to the weekly birth control
patch’s approval. The results were submitted for review by drug manufacturer
Ortho-McNeil in support of ORTHO EVRA.
Ortho-McNeil and the FDA medical officer reviewing ORTHO EVRA disagreed about
whether or not two cases of blood clots in the lungs (pulmonary embolus/PE) in
young women participating in the pre-approval clinical trials were caused by the
birth control patch. The FDA medical officer wrote:
The FDA reviewer did not agree with Ortho-McNeil’s above conclusions. The
two blood clot cases of pulmonary embolus/PE, a serious and potentially fatal
condition, must be counted as two cases in the original group. Furthermore the
FDA insisted that ORTHO EVRA’s labeling include the possible risk of fatal blood
clots such as venous thromboembolism (VTE).
The FDA also expressed concern that 211 out of 3,088 women ( or 6.8 percent) in
the pre-approval clinical trials gained 10 or more pounds in the trials and the
contraceptive effectiveness of the ORTHO EVRA birth control patch was reduced in
women weighing more than 198 pounds.
Precautions to consider before taking ORTHO EVRA:
You could be at high risk for developing certain serious diseases that can be
life threatening or may cause temporary or permanent disability or death. The
risks associated with using the ORTHO EVRA birth control increase significantly
if you:
· Smoke
· Have high blood pressure, diabetes, or high cholesterol
· Have or have had clotting disorders, heart attack, stroke, chest pain
(angina pectoris), and cancer of the breast or reproductive organs, jaundice, or
malignant or benign liver tumors
Before using the ORTHO EVRA birth control patch, you must consult your doctor
and pharmacist about all the prescription drugs, vitamins, and supplements you
are taking:
Are you allergic to estrogens, progestins, or other medications?
Be sure to mention any of the following: Tylenol, antibiotics, anticoagulants
such as blood thinners, Lipitor, cyclosporine, HIV protease inhibitors,
medications for seizures, Phenobarbital, morphine, oral steroids, thyroid
medications, St. John Wort, and many more. Your doctor may need to change the
doses of your medications or monitor you carefully for side effects.
In our 21st century pill popping society – drug interactions can be fatal and/or
could alter the effectiveness of the ORTHO EVRA birth control patch.
Why take the risk when birth control pills are a much safer option? Women should
be empowered to make the right choice for their bodies and long term health
goals.
Have you or a loved one experienced a serious problem with
the birth control patch side effects? Are you eligible for an ORTHO EVRA
lawsuit?
Fill out the below form to see if you qualify for an ORTHO EVRA lawsuit. Ask our
experienced lawyers to review your potential lawsuit. No obligation. Don’t delay.
