Product News and Recalls

What are the side-effects of 2,4,6-tribromoanisole, or TBA?

After Johnson & Johnson announced that Topamax, Tylenol, and other over-the-counter drugs may be contaminated with TBA (short for a chemical called 2,4,6-tribromoanisole), people are wondering whether should be worried about adverse health effects. TBA is also called a “halogenated anisole compound.”

Unfortunately, not much is known about the effects of TBA. The FDA reports that the risks appear to be minimal, particularly because TBA-contaminated drugs likely contain very low levels of the compound. According to the FDA there have been some reports of upset stomach, nausea, and vomiting associated with unusual odors and TBA-contaminated drugs manufactured by J&J.

Manufacturers of TBA, however, report the possibility of more serious side effects. For example, although there has not been sufficient evidence to classify it as “harmful by ingestion”, TBA may cause problems if ingested by a person who already has kidney or liver damage.  In addition, there is some evidence that human exposure to TBA can cause developmental toxicity, based on animal studies. Long-term exposure to high dust concentrations can also cause lung damage, while chronic exposure to large doses of similar compounds (bromides) have been associated with a long list of adverse health effects, including:

  • depression,
  • hallucinations,
  • irritability,
  • agitation,
  • delirium,
  • memory loss,
  • confusion,
  • disorientation,
  • forgetfulness,
  • difficulty talking,
  • weakness,
  • fatigue,
  • vertigo,
  • stupor,
  • coma,
  • decreased appetite,
  • nausea and vomiting,
  • diarrhea,
  • an acne like rash on the face, legs and trunk,
  • lack of coordination,
  • and fetal abnormalities.

Side effects of Topamax contaminated with TBA are less serious than potential side effects of Topamax if used by pregnant mothers, even Topamax without TBA contamination. Topamax use during the first trimester of pregnancy increases the risk of cleft lip, cleft palate, and other oral cleft defects by a factor of 21. If you or a loved one used Topamax or topiramate during pregnancy and gave birth to a child with cleft lip, cleft palate or other birth defects, contact Lopez McHugh, LLP for a free legal consultation. You can reach us by calling toll-free at 1-877-703-7070.