Home » Mind & Soul » Depression » Prozac Mania - Page 5

Prozac Mania - Page 5

© John McManamy

On a final note, notwithstanding my bad initial antidepressant experience, I am now on a "cocktail" that includes two antidepressants and a moodstabilizer.

---

UPDATE (June 22, 2000 and April 28, 2001)

Paradox: If you do the right thing and make your current product safer, does this amount to an express admission that your original product was found wanting? Could you be held liable? Could your behavior even be construed as fraudulent?

This is the problem Eli Lilly, makers of Prozac (fluoxetine), may be facing. The company had been preparing to launch a new version of its blockbuster antidepressant under a license agreement with Boston-area Sepracor, just as its 14-year patent was due to expire. (The company has since abandoned the project.) The original Prozac, in the wording of the patent, carries a number of risks:

"Fluoxetine produces a state of inner restlessness (akathisia), which is one of its more significant side effects ... It is also known that in some patients, use of fluoxetine is associated with severe anxiety leading to intense violent suicidal thoughts and self mutilation .... In other patients manic behavior follows treatment with fluoxetine."

According to the patent, the new Prozac would eliminate the side effects of the old drug. Sepracor filed for the patent in 1995 and it was granted in January 1998. Because technically the patent does not belong to Eil Lilly, the drug-maker may be able to distance itself from the wording on the patent.

Nevertheless, the Forsyths filed a federal lawsuit accusing the Eli Lilly of fraud.

Dr David Healy of the North Wales Department of Psychological Medicine at the University of Wales, who testified as an expert witness at the Forsyth trial, estimates that "probably 50,000 people have committed suicide on Prozac since its launch, over and above the number who would have done so if left untreated."

The jury in the Forsyth trial did not buy this testimony, and neither do a lot of scientists. Moreover, an Eli Lilly spokesman maintains: "There is no credible evidence that establishes a causal link between Prozac and violent or suicidal behavior. There is, to the contrary, scientific evidence showing that Prozac and medicines like it actually protect against such behaviors."

No doubt, the company will have ample opportunity to defend that claim in court.

UPDATE (June 12, 2001)

A Wyoming jury has returned a verdict in a wrongful death suit against GlaxoSmithKline (formerly SmithKline Beecham), makers of Paxil, with damages amounting to $6.4 million. On Feb 13, 1998, Donald Schell, 60, took two Paxil tablets, then shot to death his wife, daughter, and grand-daughter before killing himself. Unpublished data from SmithKline revealed that its own investigators had attributed a variety of side effects to the drug, including akathisia (turmoil), mania, psychosis, aggression, and attempted suicides. Dr David Healy, who has published studies on Prozac (but not Paxil) side effects, testified as an expert witness, along with Harvard psychiatrist Terry Maltsberger.

The copyright of the article Prozac Mania - Page 5 in Depression is owned by John McManamy. Permission to republish Prozac Mania - Page 5 in print or online must be granted by the author in writing.