TBO.com - TBO is Tampa Bay Online

Unapproved Cough Drugs' Days Are Numbered

ADVERTISEMENT

Bloomberg News

Published: September 29, 2007

U.S. regulators are cracking down on about 200 unapproved prescription cough medicines that contain the narcotic hydrocodone, including some marketed for young children. The Food and Drug Administration on Friday threatened to pull the products off the market if companies do not stop making and distributing them within six months.

The delay will help ensure that makers of approved drugs can accelerate production so there isn't a shortage, the FDA said.

The drugs are frequently prescribed by doctors, sometimes because they have names similar to seven FDA-approved medicines, including UCB SA's Tussionex and Endo Pharmaceuticals Holdings' Hycodan, the agency said.

Cough drugs containing hydrocodone were linked to more than 400 reports of serious side effects from dosing errors as of 2005, the FDA's Web site stated. Unapproved drugs pose more risks because they may carry inadequate warnings or falsely suggest they can be given to children as young as 2 years old, the FDA said.

'The industry continues to attempt to circumvent the law and put consumers' health at risk,' said Deborah Autor, director of the FDA's office of drug compliance. Incorrect dosing or mistaking unapproved products for approved drugs with similar names can lead to serious illness, injury or even death, she said.

The FDA declined to name any of the companies making unapproved products or their brand names. Some of them have been on the market for decades, before a law was enacted requiring all hydrocodone products to be approved by regulators. Hydrocodone is derived from codeine.

Share this:

Loading Comments...

Email Print

ADVERTISEMENT