Wellbutrin Lawyer Comments on FDA Cautioning GlaxoSmithKline on UK Plant Violations

Wellbutrin heart defect lawyer

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Wellbutrin is commonly prescribed to women who are or may become pregnant for several reasons, including as an antidepressant SSRI aid and as a smoking cessation pill. Regardless of the reason, women who take this drug may experience a greater than average risk of infant child birth defects, including but not limited to heart defects, cleft palate, cleft lip, skeletal deformations and more. If your child experienced such a horrific side effect, please call us today for a free case evaluation on how we can help.

News Reports on GlaxoSmithKline

Our team of Wellbutrin lawyers reviewed a recent article by the Dow Jones Newswires on the manufacturer of Wellbutrin, GlaxoSmithKline.  Specifically,Dow Jones Newswires (10/19, Dooren, Subscription Publication) reports that the Food and Drug Administration issued a warning letter on October 7 to GlaxoSmithKline PLC, alleging violations of its good-manufacturing practice rules at a UK plant making an antibiotic supplied to the US. The letter followed a March inspection of a plant in Worthing West Sussex making the injectable antibiotic Timentin. The agency said that GSK had failed to establish procedures to prevent microbiological contamination of drug products, as a disinfectant used in the plant was unable to remove all types of bacteria. The company said that all Timentin batches have met release standards, adding that it has been working with the agency to address issues raised by the letter and would file a “comprehensive response” by month’s end.

If you would like more information in Wellbutrin claims for birth defects, please continue reading.

The Problem

Our firm is offering free nationwide case evaluations to families whose children were diagnosed with medical conditions at birth or shortly therafter when the mother ingested Wellbutrin or Bupropion during pregnancy. Specific birth defects include cardiac malformations (ASD, VSD, Left Hypoplastic Heart Syndrome, coarctation of the aorta, Tricuspid or Pulmonary Atresia, Pulmonary Stenosis, transposition of the great vessels or any other heart defect), neural tube defect, craniosynostosis, cleft lip, cleft palate, skeletal deformations, and club foot.

About Wellbutrin

Wellbutrin is an antidepressant drug prescribed to treat major depressive disorder, also called major depression and clinical depression, and seasonal affective disorder, a type of depression involving adverse side effects that occur each year during the same season. First approved by the FDA in 1985, bupropion hydrochloride was available for several years only under the brand name Wellbutrin. In 1996, the FDA approved a sustained-release tablet of this drug called Wellbutrin SR and, in 2003, approved an extended-release tablet known as Wellbutrin XL.

Wellbutrin 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.

Wellbutrin has been linked to congenital heart defects. Congenital heart defects affect approximately 40,000 babies each year, and one of the primary known causes of such birth defects is the ingestion of teratogenic drugs during pregnancy. A teratogen is a drug or other substance capable of interfering with the development of a fetus that can ultimately result in serious birth defects.

Alleged Birth Defects

Anti-depressants have become a troubling subject when it comes to teenagers; however, some mothers are unfortunately giving birth to children with birth defects that may be connected to taking drugs called Selective Serotonin Reuptake Inhibiters (SSRIs) during early pregnancy.

SSRI birth defects, which include heart problems, spina bifida, club foot, cleft pallet, and others, are causing concerning and leading to litigation filed against the makers of these dangerous drugs.

Complaints of SSRI birth defects have been identified since at least 2005 from women who ingested during early pregnancy, Zoloft, Celexa, Lexapro, Paxil, Prozac, and Wellbutrin while pregnant. SSRI drugs are generally used as anti-depressants or to stop smoking.

A New England Journal of Medicine study found that women who took SSRIs during third trimester were six times more likely to deliver babies born with primary pulmonary hypertension (PPHN) than those who did not take the SSRIs during their third trimester.  PPHN is a lung disorder that restricts the arteries and causes blood pressure in the pulmonary artery of the heart to rise beyond control.

Symptoms of PPHN may include the following:  heart murmurs, rapid heart rate, bluish skin, low blood oxygen levels, difficulty breathing diagnosing PPHN.

PPHN is a serious birth defect.  Even after treatment, infants can be susceptible to heart failure, brain hemorrhage, seizures, kidney failure or organ damage.  Some of these birth defects can be present throughout life or even fatal.  Some infants who happen to survive PPHN nevertheless have long term breathing difficulties, seizures, developmental delays and hearing loss.

Zoloft, Celexa, Lexapro, Paxil, Prozac, Wellbutrin and Zyban are anti-depressants or smoking sensation drugs that have fallen under close scrutiny for use by expectant mothers.  As consumers of prescriptions drugs, our society assumes that pharmaceutical companies test for the safety as well as the effectiveness of prescription medication.  Unfortunately, there are and have been several drugs on the market that can cause injury, illness or even death.  In these cases, the negligence of a pharmaceutical company may warrant a personal injury lawsuit. 

Such a condition may cause surgery, lifetime defects or death.

Getting Legal Help

If your child is born with a birth defect and you had been prescribed Wellbutrin during pregnancy, you may have a claim for compensation. You may be eligible for compensation for the medical expenses for the treatment of your child and also compensation for your mental sufferings.

If you or a loved one took Wellbutrin during early pregnancy and had a child born with a birth defect, this side effect may be associated with Wellbutrin. Members of our firm are currently reviewing potential Wellbutrin lawsuits. If you have a question or have suffered serious side effects, a Wellbutrin lawyer can be reached by email or by calling TOLL FREE 1-800-632-1404.

Members of our firm are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Topamax®, Wellbutrin®, Fosamax®, and Actos®. They and members of the firm also represent clients across the globe pertaining to medical device failures, including theAdvanced Bionics HiRes90k® cochlear implant , the TVM / TVT transvaginal mesh – sling and the DePuy hip implant. For a free case evaluation, please contact:

TOLL FREE: 1-800-632-1404

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