Swiss pharmaceutical giant Novartis yesterday announced
having suspended the sales of its drug Zelnorm, used in
the treatment for constipation caused by irritable bowel
syndrome after the US Food and Drug Administration said
the product carried the risk of heart problems or strokes.
drug had been approved in July 2002, for women who had
the complication, and in August, 2004, the drug was considered
safe for use by men and women under 65.
However, under an ongoing review, Novartis analysed data
from more than 18,000 patients and its researchers found
that 13 out of 11,614 patients treated with the drug experienced
events like heart attack, stroke, or angina. Only one
in 7,031 placebo-treated patients experienced such events.
All patients affected had pre-existing cardiovascular
review of the data suggested that a causal relationship
is unlikely" between heart problems and Zelnorm use,
said Jeffrey L. Anderson, MD, an independent cardiologist
at the University of Utah who reviewed the data. "Furthermore,
the data did not show any consistent pattern of event
type, time to event or dose relationship in tegaserod-treated
the FDA is now advising patients who are using Zelnorm
to contact their health care providers to discuss treatment
alternatives. "Patients who are taking Zelnorm should
seek emergency medical care if they experience severe
chest pain, shortness of breath, dizziness, sudden onset
of weakness or difficulty walking or talking, or other
symptoms of a heart attack or stroke," the FDA said
in a press release yesterday.
FDA is still working with Novartis to allow access to
Zelnorm as an investigational drug for patients with no
other treatment options, or in other cases where the benefits
may outweigh the risks.