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Natrecor Side Effects

In August 2005, Johnson & Johnson said it issued a letter the previous month telling doctors to stop prescribing Natrecor for patients the drug was not initially intended to treat. Natrecor was FDA approved in 2001 to treat congestive heart failure or acute decompensating heart failure for the sole purpose of treating hospitalized patients. As many as 600,000 patients have been treated with the drug since its approval, but the drug has come under fire from some in the cardiology community because of potential Natrecor side effects, including increased risk of mortality and toxicity to the kidney.

The drug's labeling was updated in May 2005 to better warn about increased Natrecor side effects, specifically to include data indicating an increased risk of mortality within 30 days for Natrecor patients compared with patients taking a placebo or other treatments. The company sent letters to doctors describing which patients are appropriate to take the drug in order to minimize Natrecor side effects, and said it was launching a comprehensive recommended use initiative.

To better notify doctors and consumers about possible Natrecor side effects, the company said sales representatives and promotional speakers would be trained to specifically utilize Natrecor's recommended use in the new informational campaign, according to the company. The company said its new plan was in response to the recommendations made by an independent panel convened in May 2005 of cardiologists.

Dr. Eugene Braunwald, a highly respected heart researcher from Harvard Medical School, headed the panel, and the panel specifically recommended that Natrecor only be used in cases of an acute type of heart failure when the patient actually shows up at the hospital, and not in place of diuretics, which is the first-line treatment for heart failure, and never for outpatients, scheduled appointments or to improve kidney function. J&J's decision to take part in a "proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used" was recommended by the panel as well.

Considering the potentially deadly Natrecor side effects, Dr. Eric Topol of the Cleveland Clinic went so far to say in the July 14, 2005 edition of the New England Journal of Medicine that the drug should be off the market because the FDA was never given sufficient data upon which to have based its approval. Topol was highly critical of how Natrecor was marketed, and the company has been accused of using aggressive marketing tactics, allowing drug sales to reach almost $700 million in 2005.

Natrecor side effects relating to kidney safety were known before and during the process of FDA approval, and noted in the drug's labeling, but the increased risk of mortality was not fully known until the drug became widely used. The drug was never approved to be used as frequently as it is being used in outpatient clinics, but it was not until several years after patients were prescribed the drug that the extent of Natrecor side effects was discovered. For more information about Natrecor side effects, please contact us to confer with an attorney.

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