Ketek

Ketek was also tested at the Tucson Vivra facility.

FDA Waved Through Asthma Drugs Despite Falsified Trials 2009

Recently Alabama physician Anne Kirkman Campbell began serving a sentence in a federal prison in Lexington, KY for clinical trials she conducted of the controversial, antibiotic Ketek, linked to liver failures and deaths.

FDA Waved Through Asthma Drugs Despite Falsified Trials 2009

Despite revelations of Campbell's fraud and problems found at other study sites by regulators while the drug was being tested, Ketek sailed through the FDA and was approved on April 1, 2004.

FDA Waved Through Asthma Drugs Despite Falsified Trials 2009

The warning also states that "Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness."

Deirdre Imus: FDA: Another Government Regulatory Disaster -- II of III 2008

On February 12, 2007, the FDA finally announced that Ketek would get a "black box" warning.

Deirdre Imus: FDA: Another Government Regulatory Disaster -- II of III 2008

Fittingly, former FDA bosses Jane Henney (Vioxx) and Mark McClellan (Ketek) can claim sleep-approving.

Jamie Reidy: Sleep-blogging 2008

Having served as chairman of the Senate Finance Committee during the Vioxx and antidepressants hearings, Grassley began investigating the approval of the antibiotic drug Ketek after learning the drug was approved even though the agency knew "safety tests on the drug had been forged."

Deirdre Imus: FDA: Another Government Regulatory Disaster -- II of III 2008

Sen. Charles Grassley (R-IA) has been investigating “why FDA officials approved the sale of the antibiotic Ketek even after the government learned safety tests on the drug had been forged.”

Think Progress » ThinkFast AM: June 15, 2006 2006

The review of Ketek was thus marked by pronounced departures from accepted review practices.

Deirdre Imus: FDA: Another Government Regulatory Disaster -- II of III 2008

Manufactured by Sanofi-Aventis SA, Ketek was linked to 12 cases of liver failure including four deaths.

Deirdre Imus: FDA: Another Government Regulatory Disaster -- II of III 2008