Wellbutrin® Extended Release (XL/XR)
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The Food and Drug Administration approved Wellbutrin® in December 1985. A significant number of people had seizures, however, at the initial dosage of 400 mg to 600 mg daily, and the drug was withdrawn from the market in 1986.
Wellbutrin® Extended Release (XL/XR) vs. Sustained Release (SR)
It was later discovered that the seizures greatly depended on the size of the dose, however, and the drug was reintroduced to the market at a maximum dose of 450 mg per day in 1989. Then, in 1996, a sustained release (SR) version, meaning it was released slowly over time, of the drug was approved and was meant to be taken twice a day. This is compared to the original three-times-a-day formulation meant for immediate release.
In 2003, the U.S. Food and Drug Administration (FDA) approved a second version of the sustained release tablet, Wellbutrin® XL, meaning it was an extended release variation of the drug, and needed to be taken only once a day. In general, the terms XL and SR can be used interchangeably.
Wellbutrin® XL Side Effects
A well-known side effect of Wellbutrin®, which was the reason it was first withdrawn from the market, is the occurrence of seizures. The risk of seizures, though, depends greatly on the strength of the dose and has been judged to be:
- 0.1% at 100mg to 300 mg of Wellbutrin®
- 0.4% at 300 mg to 450 mg
- 2% at 600 mg
The risk of suicide is indicated in a black box warning on the drug literature accompanying the bottle. This risk is greatest in persons younger than 25 years old. The FDA found through statistical analyses that there was twice the incidence of thoughts of suicide and suicidal behavior in children and adolescents, and a 1.5-fold increase in young adults 18 to 24 years old.
Other side effects that have been noted include:
- High blood pressure in some patients, both with and without having high blood pressure before taking the medication
- Three cases of liver toxicity
- Dry mouth
- Ringing in the ears
- Tremor
- Sleeplessness
- Excessive sweating
Wellbutrin® XL and Pregnancy
A small number of babies of mothers taking Wellbutrin® during the early weeks of their pregnancies were born with congenital heart defects. Two types of defects found are known as left outflow tract heart defects. They are called coarctation of the aorta, which is a narrowing of the major blood vessel leaving the heart, and hypoplastic left heart syndrome, which is a drastically reduced size of the left side of the heart.
The drug might increase the risk of birth defects in infants whose mothers use the antidepressant during pregnancy. If your child is born with a defect and you took Wellbutrin® during your pregnancy, contact our Wellbutrin® attorneys for legal help.
Contact a Wellbutrin® XL Attorney
If you have suffered any serious side effects from taking Wellbutrin® or your baby was born with a heart defect after you took the medication during pregnancy, you should contact a Wellbutrin® attorney. A qualified attorney can determine if you qualify to file a legal claim.
