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Wellbutrin Side Effects
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An article published in the July 2010 issue of American Journal of Obstetrics & Gynecology suggests an increased risk of congenital heart defects when infants are exposed to Wellbutrin during early pregnancy. Specifically, an association was found between the use of Wellbutrin during the first trimester and left outflow tract defect, which can restrict blood flow to the infant's body from the left chambers of the heart. Infants born with left outflow tract defect often require surgery to correct the problem.
Wellbutrin Birth Defects
Left outflow heart defects include coarction of the aorta, hypoplastic left heart syndrome, pulmonary stenosis, aortic stenosis, teralogy of fallot ventricular septal defects and atrial septal defects.
The study involved data from 12,700 children born in the US between 1997 and 2004. Researchers found that infants exposed to bupropion during the first trimester were more than two times as likely to have a congenital heart problem. At the time, researchers recommended further studies be conducted.
Wellbutrin is classed as Pregnancy Category C, meaning there are studies conducted in animals that demonstrate a potential risk to the fetus, but there are currently not enough human studies.
In 1996, the FDA approved a sustained-release tablet of bupropion hydrochloride called Wellbutrin SR and, in 2003, approved an extended-release tablet known as Wellbutrin XL—all manufactured by GlaxoSmithKline. The drug was pulled a year later due to the high number of seizures associated with Wellbutrin side effects, but in 1989 federal reviewers allowed it back on the market after determining that reports of seizures were dose specific--Glaxo lowered the daily dosage of the drug.
Wellbutrin Side Effects
Wellbutrin belongs to the aminoketone class. It is structurally and chemically unlike other antidepressants, such as Prozac, Paxil and Zoloft. The mechanism of its therapeutic actions is not well understood, but it does appear to block dopamine uptake. Wellbutrin is sometimes used "off-label" for ADHD, weight loss, and even sexual dysfunction.
In 2004 GlaxoSmithKline, along with the FDA, issued a Wellbutrin warning to healthcare professionals stating in part, that patients being treated with antidepressants may "experience worsening of their depression and/or the emergence of suicidal ideation and behavior". Professionals were encouraged to watch closely for signs of "clinical worsening and suicidality" in their patients, particularly when starting or stopping the drug, as well as when dosages are changed.
Wellbutrin FDA Warning
In October 2004 the FDA approved the following for inclusion on a "black box" warning: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders." Wellbutrin is not approved by the FDA to treat depression in children. Patients, especially those younger than 24 years of age, can experience worsening suicidal thoughts and behaviors.
Wellbutrin Depression and Suicidal Thoughts
Like Wellbutrin, Zyban is known generically as bupropion hydrochloride. Zyban is used as a smoking cessation drug and Zyban side effects may be similar to Wellbutrin side effects. On July 1, 2009, the FDA required the maker of Zyban to include a boxed warning about the risk of mental health events. Such Zyban adverse effects could include changes in behavior, depressed mood, hostility and suicidal thoughts, in patients when taking Zyban.
Zyban Side Effects
Wellbutrin Legal HelpIf you or a loved one has experienced side effects from the use of Wellbutrin or if you have taken Wellbutrin while pregnant and your child has suffered from a birth defect, please click the link below to submit your complaint and we will have a lawyer review your case.
Last updated on Aug-5-11
WELLBUTRIN LEGAL ARTICLES AND INTERVIEWS
Study Suggests Link between Wellbutrin and Birth Defects
Seattle, WA: It has been just over a year since a study was published in the American Journal of Obstetrics & Gynecology suggesting a link between the use of Wellbutrin early in pregnancy and the development of Wellbutrin birth defects. The study concluded that more data would be needed to confirm potential Wellbutrin side effects on infants. Additional studies have not been conducted, but the FDA has Wellbutrin in pregnancy category C and suggests that it should be used during pregnancy only if the potential benefit justifies the potential risk [READ MORE]
How Much 'Well' is Associated With Wellbutrin?
Washington, DC: There appears to be some disconnect as to just what FDA pregnancy category Wellbutrin is assigned to. Most sources hold that the drug is categorized as 'C', which is described by the Journal of Counseling and Development (JCD) as posing a potential risk to the fetus that cannot be ruled out, due to the fact that animal-based studies have shown adverse effects on the fetus, but that no well-controlled studies on pregnant women have shown conclusive results [READ MORE]
Former Glaxo Executive Indicted
Durham, NC: A long-promised crackdown on pharmaceutical executives accused of potential wrongdoing is gaining momentum with the indictment yesterday of a former vice president and legal counsel of GlaxoSmithKline (Glaxo). While the pharmaceutical giant is headquartered in the UK, its US operations are based in North Carolina [READ MORE]
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