Recent studies have linked Organon’s popular antidepressant medication Remeron (generic: mirtazapine) to a number of extremely serious side effects in users and birth defects in babies born to mothers who took the drug during pregnancy. The Federal Government’s Adverse Drugs Reactions Committee has received dozens of reports of blood and bone marrow abnormalities, liver problems, and suicidal ideations associated with Remeron. Additionally, antidepressants similar to Remeron have been linked to congenital birth defects including (but not limited to) atrial septal defects (ASDs), hypoplastic left heart syndrome (HLHS), patent ductus arteriosus (PDA), and persistent pulmonary hypertension of the newborn (PPHN).
Manufactured and marketed by Netherlands-based Organon International, Remeron is a tetracyclic antidepressant that works by affecting chemicals in the brain that may become unbalanced and cause depression and other serious psychological disorders. Remeron is thought to increase the activity of serotonin and norepinephrine in the brain, thereby helping elevate the patient’s mood. The drug comes as an orally-ingested tablet that is intended to be taken once a day at bedtime.
Remeron was first approved by the U.S. Food & Drug Administration (FDA) in 2001 for the treatment of mental depression, but has since been prescribed in an off-label capacity to treat the following conditions:
- Panic / anxiety disorders
- Bipolar depression
- Sleep disorders
- Chronic fatigue
- Irritable Bowel Syndrome
Side Effects of Remeron
Some patients have experienced bouts of confusion, vomiting, rash, dizziness, dryness of the mouth, upset stomach, and drowsiness after taking Remeron. Other, more serious reactions associated with Remeron include:
- Chest pains
- Fast heartbeats
- Serious blood and bone marrow abnormalities
- Agranulocytosis (disorder that causes damage to the bone marrow and a failure to produce white blood cells)
- Liver problems
- Bouts of mania
Remeron & Suicide
Remeron and other similar antidepressants have long been suspected of contributing to suicidal and/or violent behaviors, especially in children. This point of view has recently been adopted by the FDA. In October 2003, the administration notified healthcare professionals of reports of suicidality (both suicidal ideation and suicide attempts) in clinical trials for Remeron and other similar antidepressant drugs in children and young adults with major depressive disorder. The administration completed a review of such reports for Remeron, Prozac (fluoxetine), Celexa, Paxil (paroxetine), Zoloft (sertraline), and Effexor studied under the pediatric exclusivity provision, and concluded that additional tests and analysis are needed.
Then in December 2006, the FDA issued a press release warning the public that prescribing antidepressants to young adults is risky. The administration proposed updating the warning labels of all such medications to include data about suicidal ideations in patients between the ages of 18 and 24. The label change would expand the current warning that pertains only to children and adolescents treated with antidepressants, and contain a suggestion that patients of all ages be monitored carefully when undergoing treatment with the drugs.
Remeron & Death
In addition to these side effects, antidepressants like Remeron have also been associated with an increased risk of death in patients with coronary artery disease (CAD). A recent study conducted by researchers at Duke University analyzed the survival rate of heart disease patients using antidepressants compared with those taking no such medications. After a median of 36 months after follow-up, more than 20% of the patients being treated with antidepressants had died, compared to just 12.5% of those not taking antidepressants. The study concluded that antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.
Remeron Birth Defects
The following birth defects have been linked to antidepressants like Remeron when taken by expecting mothers during pregnancy (especially during the first trimester, a time when many women may still be unaware they are pregnant):
- Atrial Septal Defects (ASD)
- Ventricular Septal Defects (VSD)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Tricuspid Valve (Ebstein’s Anomaly)
- Mitral Valve Prolapse
- Transposition of the Great Arteries (TGA)
- Transposition of the Great Vessels (TGV)
- Tetralogy of Fallot (TOF)
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Atresia
- Aortic Stenosis
- Pulmonary Atresia (PA)
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Tricuspid Valve Stenosis
- Heart Murmur
- Pulmonary Stenosis
- Gastroschisis – abdominal wall defect
- Esophageal Stenosis
- Anal Atresia
- Spina Bifida
Remeron is currently classified by the FDA as a Pregnancy Category C drug, which means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans. With regard to birth defects, medical experts stress that Remeron should only be used during pregnancy when potential benefits outweigh the inherent risks.