Serious drug side effects can be devastating in any case, and particularly tragic when affecting the lives of unborn babies. Benicar, a high blood pressure medication manufactured by Daiichi-Sankyo, was approved by the U.S. Food and Drug Administration (FDA) on April 5, 2002 and released on the market for public use. A number of serious side effects have since been reported for this drug, based on research and post-marketing experience.
Perhaps the most alarming adverse effect of taking Benicar is fetal toxicity. This drug crosses the placental barrier during pregnancy and has damaging, toxic effects on the fetus.
Safety labeling changes warning of fetal toxicity were not issued by FDA until March 2012 (although a boxed warning to avoid use during pregnancy appeared in February 2012). Drug manufacturers have a duty to the public to thoroughly test their products for safety before bringing them to market, and a responsibility to warn patients and their doctors of any potential side effects.
If your child suffered fetal toxicity because of Benicar, it is in your best interest to speak with a knowledgeable drug injury lawyer. Our legal practice at Farah & Farah is focused exclusively on representing people who have been seriously injured by dangerous drugs and medical devices. You can rely on our pharmaceutical litigation attorneys to thoroughly investigate your claim and fight tenaciously for the compensation you are entitled to receive.
FDA Warning of Fetal Toxicity with Benicar
As of March 2012, FDA instructs patients and physicians to discontinue Benicar as soon as possible when pregnancy is detected. FDA warns that drugs acting directly on the renin-angiotensin system (system involving hormones that regulate blood pressure and fluid balance) can be fatal or cause injury to the developing fetus.
Further, FDA warns that use of this type of drug during the second and third trimesters of pregnancy can reduce fetal renal (kidney) function and increase morbidity (incidence of disease) and death in the fetus and newborn. It can cause oligohydramnios (lack of amniotic fluid), which can be associated with skeletal deformations and lung hypoplasia (incomplete development of the lungs).
Potential adverse effects on the newborn when Benicar is taken during the second or third trimester, as listed by FDA, include:
- Skull hypoplasia (incomplete development of the skull)
- Anuria (failure of the kidneys to produce urine)
- Renal failure (kidney failure)
- Hypotension (abnormally low blood pressure)
In its patient counseling information, FDA instructs physicians to:
- Tell female patients of childbearing age about the consequences of taking Benicar during pregnancy.
- Discuss treatment options with women who are planning to become pregnant.
- Ask patients to report pregnancies as soon as possible.
Effects of Drugs during Pregnancy
According to the Merck Manual, medications should not be used during pregnancy unless absolutely necessary. Drugs can harm the fetus in several different ways. They can:
- Act directly on the fetus, causing abnormal development, damage, or death;
- Alter the function of the placenta, reducing the oxygen and nutrient supply to the fetus;
- Cause the muscles of the uterus to forcefully contract, reducing the blood supply and injuring the fetus, or triggering early labor; or
- Affect the fetus indirectly — for example, drugs that lower the mother’s blood pressure can reduce blood flow to the placenta.
In cases of preeclampsia, eclampsia, or high blood pressure during pregnancy, however, hypertension medication may become necessary. High blood pressure can increase the risk of complications for both the baby and the mother.
Pregnant women on hypertension medication must be closely monitored. If the drug lowers blood pressure too quickly, it can reduce blood flow to the placenta and interfere with the oxygen and nutrient supply to the fetus.
Drug Categories for Risk during Pregnancy
The FDA classifies drugs according to their risks to the fetus if taken during pregnancy. Category A drugs carry the lowest risk – well-designed studies in people have shown that they present no risk for the fetus. Category B drugs are not quite as safe – studies on animals show no risk to the fetus, but no human studies have been done.
Benicar is a Category D drug. In this category, evidence of human fetal risk has been demonstrated in human studies. In certain circumstances (life-threatening situations, for example), the benefits may outweigh the risks and a Category D drug may be acceptable for use.
If your child has suffered birth defects or serious injury and you were on Benicar during your pregnancy, call Benicar injury attorneys at Farah & Farah by dialing (800) 533-3555 for a free case evaluation. We can advise you of your options under the law and provide you with the high-quality representation you need to seek justice and compensation.