FDA Approves Prozac Sale in Liquid Form

The Food and Drug Administration has granted marketing approval for a liquid form of the antidepressant Prozac, the drug’s maker, Eli Lilly & Co., said Thursday.

Lilly called the FDA approval “another affirmation of the safety” and effectiveness of Prozac in treating clinical depression, and used its announcement to lash out at critics who have put the drug at the center of a legal and medical hornet’s nest.

“As is now coming to light, much of the criticism of Prozac has been generated by a non-scientific, self-serving campaign that is clearly contradicted by the overwhelming weight of medical and scientific evidence,” W. Leigh Thompson, group vice president of Lilly Research Laboratories, said in a statement.

Prozac, the top-selling anti-depression drug since shortly after its introduction in 1988, is literally being put on trial. Critics contend Prozac can cause patients to have suicidal or even murderous tendencies, and in several criminal cases, defendants have sought to attribute their violent behaviors to Prozac. However, in six such cases that have been completed, according to a Lilly spokesman, the so-called Prozac defense failed and the defendants were convicted.

The drug is also the target of many product liability cases, including wrongful death suits involving patients who committed suicide. Lilly maintains that there is no medical evidence to support claims that Prozac causes such behavior. And many physicians report that Prozac is more effective and has far fewer side effects than previously available drugs used to treat severe depression.