pregnant woman
Women's Health

Side Effects From Big Pharma: Wellbutrin – Dangerous for You and Your Baby

Shawn Steel, JD

Are some of your pregnant patients taking Wellbutrin? If so, it could be a danger to them and their baby. This drug is extremely popular, but it has a serious history. Wellbutrin promised to make patients "happy, horny and skinny," plus they might even quit smoking. GlaxoSmithKline's sales department promised physicians the pills would sell. But then came the side effects, including strokes and much more.1

Wellbutrin is an antidepressant. It is used to treat depression including seasonal depression, otherwise known as SAD (Seasonal Affective Disorder), the blues that may occur in the fall and winter. Scientists claim Wellbutrin should work by increasing certain types of brain activity.

The drug is also used to treat attention deficit hyperactivity disorder, ADHD (a longtime suspect diagnosis); difficulty focusing or controlling actions; antidepressive disorder; or episodes of other abnormal moods. My favorite diagnosis: "remaining [more] still or quiet than other people who are the same age."2 We used to call those good kids. Now we have a pill for them.

For those who like to dabble with more exotic issues, the literature reports that Wellbutrin is used for popular off-label uses such as getting high, weight loss, bipolar depression, RLS (restless leg syndrome), pathological gambling and sexual dysfunction. The FDA does not approve Wellbutrin for any of these conditions. Restless leg syndrome – really?

Side Effects: Some Moderate, Some Severe ... Some Deadly?

When given to women who are suffering from pregnancy depression or postpartum depression, Wellbutrin may increase the risk of serious birth defects including heart defects (left outflow heart defect), bilateral club feet, and reduced testicles for male babies. It may also interfere with fetal growth. Depressingly, the Mayo Clinic still recommends Wellbutrin for depression during pregnancy.

Stark problems created when pregnant women take antidepressants are internationally recognized. Regulatory agencies from several countries are warning that antidepressants may induce birth defects including heart and lung malfunction, preterm births and numerous other physical defects.

But what has made Wellbutrin infamous is the initial large number of seizures reported; so many that Wellbutrin was initially withdrawn from the market.3 And that's not to mention the "moderate" and serious side effects from the drug,2 which according to the National Institutes of Health include:

Moderate Side Effects

  • headache
  • nausea
  • vomiting
  • uncontrollable shaking of a part of the body
  • rash or blisters
  • itching
  • hives
  • weight loss
  • drowsiness
  • excitement
  • dry mouth
  • dizziness
  • constipation
  • excessive sweating

Serious Side Effects

  • confusion
  • hallucinations
  • irrational fears
  • fever
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles or lower legs
  • hoarseness
  • difficulty breathing or swallowing
  • chest pain
  • muscle or joint pain
  • rapid, pounding or irregular heartbeat

Oh, and by the way, suicide can also be a problem. The FDA requires all antidepressants to carry a "black box" warning stating that antidepressants may increase suicide risk in individuals younger than age 25.4 (With all the side effects, I might suggest that slow, lingering, painful death is an additional possibility.)

Big Pharma Warnings

GlaxoSmithKline is quick to tell you on its website that Wellbutrin is not for everyone. GSK admits a risk of seizure. It suggests that you should not take Wellbutrin with alcohol or sedatives, or monoamine oxidase inhibitors (MAOIs) or certain other medications, or with a nicotine patch, or if you have liver or kidney problems.

Reassuringly GSK informs us that Wellbutrin "is approved only for adults 18 years and over." However, "in some children, teens, and young adults, antidepressants increase suicidal thoughts or actions."

A Little History of Wellbutrin, Including Fraud and Bribery

Bupropion was invented by scientist Nariman Mehta in 1969.5 It was then approved by the U.S. Food and Drug Administration (FDA) as an antidepressant on December 1985 and marketed under the name Wellbutrin. Increased incidence of seizures, however, caused the withdrawal of the drug in 1986. Wellbutrin was re-introduced to the market in 1989.

In 2012, the U.S. Justice Department announced that GlaxoSmithKline had agreed to plead guilty and pay a $3 billion fine, in part for promoting the unapproved use of Wellbutrin for weight loss and sexual dysfunction.6 GSK also was charged by the federal government for paying kickbacks to doctors and misrepresenting its products to the public. GSK secretly employed media physiologist and sex advice guru, Dr. Drew Pinsky, with his popular "Loveline" show. Dr. Drew was paid some $275,000 to promote the drugs, without informing anyone he was paid. One of the key drugs involved in the scandal was Wellbutrin.7

Talk to Your Patients

Wellbutrin has made GSK rich and continues to do so today. Naturally, there are many lawsuits pending against the manufacturer – but the (monetary) benefits for GSK certainly outweigh the costs. If you know a patient is taking Wellbutrin, particularly if they are pregnant, you might suggest they get a second opinion from an MD you trust. If the patient is already suffering side effects from the use of Wellbutrin, legal counseling also may be appropriate.

References

  1. Hensley S. "Glaxo to Plead Guilty to 3 Charges in Sweeping Health Settlement." NPR.org, July 2, 2012.
  2. Information about bupropion [Wellbutrin]. National Institutes of Health (Medline Plus).
  3. Bupropion: medical uses, contraindictions, side effects and mechanism of action. Wikipedia.com.
  4. Boxed Warning. Wikipedia.com. [See also: Stretch K. "Antidepressants Get FDA's 'Black Box' Warning." Dynamic Chiropractic, Nov. 30, 2004.]
  5. Nariman Mehta - designer and synthesizer of bupriopion (Wellbutrin). Wikipedia.com.
  6. Petersen DM. "Crime Does Pay – Big: GlaxoSmithKline Fined $3 Billion; Stock Rises." Dynamic Chiropractic, Sept. 9, 2012.
  7. Whalen J. "'Dr. Drew' Was Paid by Glaxo; Radio Host Extolled Virtues of Antidepressant After Attending Events for Firm." The Wall Street Journal, July 3, 2012
May 2013
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