Expert Testimony on Zelnorm
What follows is a sampling of quotes from people knowledgeable about Zelnorm and its various symptoms and side effects, and the resultant Zelnorm lawsuits:
“Once again, the FDA has approved a drug with marginal
effectiveness in the face of serious questions about its safety—putting
at risk the millions of people who have already used it.”
—Dr. Sidney Wolfe, director of Public Citizen’s Health
Research Group
“Tegaserod [Zelnorm] is a drug that is, at best, minimally effective and that may be causing substantial harm.”
—Dr. Elizabeth Barbehenn, in 2004
“We believe that the risk-versus-benefit profile of Zelnorm is no
longer favorable…. It took really pulling together all 29 studies
that have been conducted throughout the entire life of the product to
see this level of a signal.”
—Dr. John Jenkins, director of the FDA’s Office of New Drugs
“The FDA currently has 21 reports of diarrhea so severe that it
caused such complications as low blood pressure and fainting. Sixteen
patients required hospitalization.”
—Dr. Robert Justice of the FDA
“This decision reflects the FDA’s commitment to continuously
monitor approved drugs throughout their marketing life and take action
when we believe the risks outweigh the benefits. Here, a potential risk
of very serious harm to patients who have this non-life-threatening
condition was recently identified, making this action necessary.”
—Dr. Douglas Throckmorton, deputy director of the FDA’s Center
for Drug Evaluation and Research
“We have to wait and see how many patients feel like they were
really gathering significant benefit from Zelnorm and whose symptoms
were so severe that they’d consider continuing to take the drug.”
—Dr. John Jenkins on the possibility of a limited reintroduction
of Zelnorm to the market
“When you remember that a number of patients taking this drug are
younger, otherwise healthy people, the tolerance for serious side
effects should be very low, even if they are rare.”
—Peter Lurie of Public Citizen, expounding on his calculations that
people on Zelnorm are seven or eight times more likely to
suffer heart problems
“Since Zelnorm went on sale in 2002, the FDA has received 20
reports of ischemic colitis, plus three reports of a similar intestinal
problem. Fourteen patients were hospitalized. Four died, although they
had numerous other serious medical conditions.”
—Dr. Robert Justice