Natrecor Attorneys
Natrecor, also known as Nesiritide, was approved by the FDA in 2001 for
a type of acute congestive heart failure accompanied by shortness of breath.
It was restricted to only be given in emergency settings and only to the
sickest patients. In recent years, some physicians have given Natrecor
on a regular basis to heart failure patients who weren't suffering from
serious breathing problems. Natrecor was increasingly being used for off-label
uses.
Almost 600,000 patients have been prescribed Natrecor since 2001, but
serious safety concerns have emerged, linking the drug to kidney problems
and elevated death rates. It can take years before actual drug risks are
realized, after a drug is being widely used, but issues of kidney safety
were known prior to and during the FDA approval process. Natrecor labeling
specifically noted the kidney risks in the labeling, but the drug's manufacturer
- Scios who was bought by Johnson & Johnson in 2003 - has been accused
of aggressively marketing the drug, which could have exposed a greater
number of people to the drug's risks unnecessarily.
Prescribing a drug off-label has become a common and increasingly controversial
practice among doctors. While there have been significant benefits to
prescribing drugs for purposes it was not specifically approved for, it
is illegal for a company to promote a drug for reasons besides what the
FDA has recognized and approved. Scios' marketing strategies for Natrecor
have been questioned in addition to promotional materials the company
provided doctors.
Several journal articles provided data linking Natrecor to kidney problems
and elevated death rates, but Scios argued one of the papers by Dr. Jonathan
Sackner-Bernstein, a cardiologist at North Shore University Hospital in
New York, included studies done at higher doses than are advised on Natrecor's
label.
These patients taking Natrecor were 80 percent more likely to die within
the next 30 days than patients who had received other treatments. In May
2005, an independent expert panel of cardiologists set strict limitations
on Natrecor to be restricted to severely ill hospitalized patients.
Also, J&J announced it would revise Natrecor labeling to include data
indicating an increased risk of mortality within 30 days compared with
patients taking a placebo or other treatment, in compliance with the FDA.
Even with the increased Natrecor warnings, medical experts still wanted
further studies to better determine health risks.
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