Original data analyzed by two cardiologists threw up safety concerns around the drug suggesting it may damage the kidneys and even increase the risk of death. The following review by high profile authorities in the field supported the original findings suggesting J&J should produce stricter limits on the use of the drug and conduct a large-scale clinical trial to evaluate the drug’s efficacy.
The committee decided a clinical trial was necessary to thoroughly assess the risks and benefits of the drug as current data is not sufficient to support its use. They also considered that doctors should be dissuaded from prescribing Natrecor for ailments other than those specifically approved by the FDA such as kidney dysfunction.
The recommendations advise the limitation of the drug’s use to inpatients in a serious condition, warning against using regular serial infusions of the intravenous therapy in outpatients, an emerging practice by cardiac doctors.
Natrecor was originally acquired by J&J as part of the company’s purchase of the biotech firm Scios for $2.4 billion in 2001. The drug was originally billed as a potential blockbuster, with sales doubling since its release in 2001.
J&J has said it fully accepts the recommendations of the panel and will be moving forward with them. A clinical trial of the drug is already being planned.