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Revised Warning for Anti-Smoking Drug

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Adam Bitner5 years ago

The U.S. Food and Drug Administration (FDA) revised the black box warning for the anti-smoking drug Aplenzin, listing a risk of suicidal thoughts as a side effect for people who use the drug to quit smoking. Aplenzin contains bupropion hydrobromide, which is an antidepressant also known as Wellbutrin, Zyban, and Buproban.

Aplenzin is not currently indicated for treatment of smoking, although it is often prescribed off-label for these uses. Zyban, which has the same active ingredient, is indicated for treatment of smoking cessation.

Major Risks Associated With Medication

  • Bupropion hydrobromide lists side effects such as seizure, hallucination, loss of consciousness, as well as other less serious side effects.
  • Children and young adults up to 24 years of age were susceptible to suicidal thoughts while taking the medication.
  • Anyone prescribed antidepressant medication should be aware of the risks and side effects before they begin use of the drugs.

Antidepressants Especially Dangerous for Children

  • Children and teenagers younger than 18 experience a greater risk for suicidal thoughts and depression while on mood elevators like bupropion hydrobromide.
  • According to an article at, in 2002, 18 million children and adolescents were prescribed antidepressants and about 30% attempted suicide.
  • Antidepressants for children can be dangerous.
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If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.


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