Unapproved Eardrops Under FDA Scrutiny After Infant Death


The FDA ordered drug companies to stop making and marketing unapproved eardrops after an infant suffered a fatal reaction to eardrops including an unapproved ingredient.

“These products haven’t been shown to be effective in anyone, and there’s no proof that they work,” said an FDA medical officer.

The infant died from a blood reaction with benzocaine, an ingredient in the eardrops not yet approved by the FDA for prescription medications.

In a Wednesday report, the FDA showed other minor reactions linked to benzocaine:

  • Irritation
  • Stinging
  • Itching
  • Burning
  • Hypersensitivity

The drops are used to treat ear infections, earwax buildup, and inflammation, but the presence of the unapproved ingredient makes them dangerous – if not lethal.

To get approval from the FDA, the products must show their effectiveness and safety.

The following ingredients are not approved by the FDA:

  • Chloroxylenol
  • Pramoxine
  • Benzocaine
  • Antipyrine
  • Zinc Acetate
  • Antipyrine

The FDA’s order will not influence over-the-counter drugs or eardrops with FDA-approved ingredients. If your child was prescribed an unapproved medication for an ear infection, contact your healthcare provider today.

When to Contact a Lawyer

If your child sustained a serious reaction to an unapproved medication, the Washington, DC product liability attorneys at Simeone & Miller, LLP, LLP invite you to contact our office. We will give a free, no-obligation consultation to discuss your case and possible legal action.