Zyban SSRI Antidepressant | Lawsuit, Lawyer | Side Effects: Birth Defects (Skeletal, Neural Tube, Heart, and Limb Birth Defects, Cleft Lip, Cleft Palate), Suicidal Behavior, and Serotonin Syndrome | Other SSRI Antidepressants: Effexor, Lexapro, Paxil, Prozac, Wellbutrin, and Zoloft
Gilman Law LLP, a leading national law firm with over 30 years of experience protecting the rights of victims, is now accepting claims for lawsuits involving side effects such as birth defects, suicidal behavior, and psychiatric problems associated with the use of the smoking cessation aid, Zyban.
If you or someone you know has taken the SSRi Zyban during pregnancy and the birth child was born with a birth defect, skeletal defect, neural tube defect, heart defect, limb birth defects, cleft lip or cleft palate, or you have developed suicidal behavior, or serotonin syndrome, you may be a victim of a SSRi side effect.
Zyban Side Effects and Symptoms
Birth Defects: Zyban carries a Pregnancy Category C classification, meaning that animal reproduction studies have shown an adverse effect on the fetus but that no adequate or well-controlled studies in humans have been performed.
Suicidal thoughts and behavior: In 2004 GlaxoSmithKline issued a warning that patients treated with bupropion, the active ingredient in Zyban, may “experience worsening of their depression and/or the emergence of suicidal ideation and behavior.”
Psychiatric Side Effects: Zyban bears a Black Box stating that it may cause changes in behavior, including depressed mood, hostility and suicidal thoughts.
FDA Warnings for Zyban and Birth Defects
In 2004, the FDA released a warning against the use of certain antidepressants, including Wellbutrin for women in the late third trimester of pregnancy. In 2006, the agency issued a safety alert regarding the increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Both alerts covered drugs like Wellbutrin, along with other antidepressant medications. Because Wellbutrin and Zyban contain the same active ingredient – bupropion – it is possible that Zyban carries similar risks.
A 2010 case-control study published in the American Journal of Obstetrics and Gynecology suggests that women who take Zyban during early pregnancy may run a greater risk for having a baby born with a heart birth defect. This study identifies a positive association between early pregnancy Zyban use and left outflow tract heart birth defects. Though the study did not conclusively prove a connection between Zyban and heart birth defects, women taking Zyban who are planning to become pregnant should speak with their doctors about the potential side effects and alternative options.
FDA Warnings for Bupropion and Suicide
In October of 2004, the FDA issued a Public Health Advisory concerning bupropion for depression and possible links to an increase in child suicide ideation. The FDA also ordered the manufacturers of antidepressants, including bupropion for depression, to include a Black Box warning on the drug label, warning of the possible link between antidepressants and child suicide. In December 2006, the suicide Black Box warning was expanded to include young adults, ages 18 to 25.
FDA Warning for Zyban and Psychiatric Side Effects
In 2009, the FDA required the maker of Zyban to put information about the risk of behavior changes, depression, hostility and suicidal thoughts in a Black Box on the warning label, which is the strongest warning that can be placed on a prescription medication.
What is Zyban?
Zyban is known generically as bupropion and is manufactured by GlaxoSmithKline. Zyban was approved for use as a smoking cessation aid on May 14, 1997, and helps to reduce the side effects associated with nicotine withdrawal. Another form of bupropion is sold as Wellbutrin, and is approved to treat various forms of depression. Wellbutrin has been linked to birth defects, as well as suicidal behavior in children, teens and young adults. Because it contains the same active ingredient, it is possible that Zyban shares many of Wellbutrin’s risks.
Legal Help for Victims of Zyban Side Effects
If you or someone you know suffered from birth defects, suicidal behavior or psychiatric side effects that could be linked to Zyban, Gilman Law is here to help. For a free evaluation of your case, please fill out the online form on the left or call Toll Free at 1-888-252-0048.