Warnings Increased About Risk Of Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)
(Posted by Tom Lamb at DrugInjuryWatch.com)
In March 2011 Ortho-McNeil-Janssen Pharmaceuticals, Inc. revised the Prescribing Information (more commonly called the "package insert" or "label") for its Ortho Evra (norelgestromin/ ethinyl estradiol) transdermal system to give a stronger warning about blood clot related side effects like pulmonary embolism (PE) and deep vein thrombosis (DVT).
Previously, the Boxed Warning, or "Black-Box" Warning, for the Ortho Evra skin patch birth control product only included a short paragraph titled "Cigarette Smoking and Serious Cardiovascular Risks".
Now the Ortho Evra label (accessed 4/18/2011) has a Black Box warning which includes these two new paragraphs about a woman's risk of suffering adverse events while using the Ortho Evra patch:
Risk of Venous Thromboembolism
The risk of venous thromboembolism (VTE) among women aged 15-44 who used the
ORTHO EVRA® patch compared to women who used oral contraceptives containing
30-35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was
assessed in four U.S. case-control studies using electronic healthcare claims data. The
odds ratios ranged from 1.2 to 2.2; one of the studies found a statistically significant
increased risk of VTE for current users of ORTHO EVRA® (see WARNINGS -
Table 5).
Pharmacokinetic Profile of Ethinyl Estradiol
The pharmacokinetic (PK) profile for the ORTHO EVRA® patch is different from the
PK profile for oral contraceptives in that it has higher steady state concentrations and
lower peak concentrations. Area under the time-concentration curve (AUC) and
average concentration at steady state for ethinyl estradiol (EE) are approximately
60% higher in women using ORTHO EVRA® compared with women using an oral
contraceptive containing 35 mcg of EE. In contrast, peak concentrations for EE are
approximately 25% lower in women using ORTHO EVRA®. It is not known whether
there are changes in the risk of serious adverse events based on the differences in PK
profiles of EE in women using ORTHO EVRA® compared with women using oral
contraceptives containing 30-35 mcg of EE. Increased estrogen exposure may
increase the risk of adverse events, including venous thromboembolism. (See
WARNINGS and CLINICAL PHARMACOLOGY, Transdermal versus Oral
Contraceptives.)
Our March 2010 article about the safety profile of Ortho Evra, "Recent Report About Ortho Evra Safety Seems To Contradict Earlier Findings From Same Group", covered some of the developments which led to an April 2010 Ortho Evra label change.
______________________________________________________________________________
DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects
Drug Injury Case Evaluation - Free & Confidential