Action 9

Charlotte woman urges senators to police FDA better

CHARLOTTE, N.C. — A Charlotte woman was in Washington on Wednesday, asking the North Carolina senators to be more heavy-handed with the U.S. Food and Drug Administration.

Rachel Brummert met with Sens. Richard Burr and Thom Tillis, urging them to police the FDA better.

"We are real people with real issues, and we need their help. We need them to step up and to protect patients and to make sure this doesn't happen to anybody else," she said.

She wants:

  1. The FDA to follow up on drugs more aggressively after it approves them
  2. Congress to form an oversight committee to oversee the FDA
  3. The FDA to overhaul its reporting program, Medwatch
  4. Congress to include more patient safety provisions in the bill known as the Cures Act

Brummert is executive director of the Quinolone Vigilance Foundation.

She got involved in this issue because of certain popular antibiotics, called fluoroquinolones. Action 9's reported on them extensively. They have the brand names Avelox, Cipro and Levaquin.

They can be very effective for treating infections, but some patients -- like Brummert -- say they took these drugs and suffered severe side effects. In her case, she said she's had ongoing muscle and tendon pain for years.

Read our past coverage:

Drug companies defend the antibiotics. Bayer, which makes Cipro, said they can be very effective when used on the right patient.

The FDA is thinking of requiring stronger warnings for those meds. But, no matter what it decides, Brummert would like to see changes.

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