Feraheme Linked to Adverse Events

Reports of the drug <"http://www.yourlawyer.com/practice_areas/defective_drugs">Feraheme being linked to so-called “life-threatening” events led to AMAG Pharmaceuticals shares to fall 21 percent, its lowest in just about five years, wrote Reuters. The reports have also shed doubt on Feraheme’s future sales.

AMAG said that fatal events, such as “hypersensitivity and cardiac events,” have been reported after patients have taken the pharmaceutical maker’s key medication, a kidney drug, said Reuters. The US Food and Drug Administration (FDA) approved Feraheme in 2009 to treat iron-deficiency anemia in adults diagnosed with chronic kidney disease.

AMAG Pharmaceutical shares have fallen over 30 percent since Feraheme was included in the FDA list of potential drug safety concerns this August, said Reuters.

Eun Yang, an analyst with Jefferies & Co analyst stated that a 50 percent chance exists for a “black box warning” for Feraheme, which could adversely affect future sales, said Reuters. Sales of the drugs dropped six percent from the second quarter to $15.1 million in the third quarter, noted Reuters. A black box warning, the FDA’s strongest, points out a drug’s safety risks as well as “an extension of the observation period after administration of the drug,” explained Reuters.

“We believe if Feraheme’s label includes a black box, future revenues will likely be a fraction of our current estimates and AMAG will struggle to become a profitable and perhaps even viable company,” Ladenburg Thalmann analyst Juan Sanchez said, quoted Reuters. Thalmann also pointed out that whether a black box warning is called for, a final outcome for the medication would be difficult to predict, especially in light of increased US health regulator oversight, said Reuters. Sanchez gave the stock a “neutral” rating.

Meanwhile, the Boston Business Journal (BizJournal), just reported that the FDA sent a warning letter to AMAG’s CEO, telling the company that its websites touting Feraheme and another one of the company’s products neglected to include details on the risks associated with the medications. The omissions are essentially a misbranding of the medications, which is in violation of FDA rules, said the FDA, wrote BizJournal.

The other medication, GastroMARK is used diagnostically and orally in magnetic resonance imaging (MRI) to increase demarcation of the bowel so that it can be distinguishable form other organs and tissues near the upper area of the gastrointestinal tract. The GastroMARK webpage omits the medication’s contraindication that can occur in people with “known or suspected intestinal perforation or obstruction,” said BizJournal.

The FDA letter reads, in part: “These violations are concerning from a public health perspective because they suggest that GastroMARK is useful in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience, and that GastroMARK and Feraheme are safer than has been demonstrated by substantial evidence or substantial clinical experience,” quoted BizJournal.

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