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It is illegal for any drug or medical device manufacturer to advertise their products for uses other than those approved by the Food and Drug Administration (FDA). Though doctors may prescribe treatments as they see fit, manufacturers cannot encourage healthcare professionals or patients to consider products for non-approved uses.

That’s why in 2015, the FDA sent a letter to Luitpold Pharmaceuticals (parent company of American Regent and a wholly owned subsidiary of Daiichi Sankyo) about a video advertisement the company released concerning the iron-replacement product, Injectafer (ferric carboxymaltose or FCM).

Injectafer Provides Misleading Information in Video Advertisement

Injectafer is an injectable iron supplement, designed to treat iron deficiency anemia. This is a condition in which because of a deficiency in iron, a patient does not produce enough hemoglobin in the red blood cells. Since hemoglobin carries oxygen to other organs and tissues, a lack of it can cause symptoms like shortness of breath, fatigue, and pale skin.

The condition is typically treated with oral iron supplements or iron pills, but it can take several weeks to restore iron levels to normal. Some people have trouble digesting the pills or can’t absorb them well. Others, because their anemia is severe or because they’ve lost a lot of blood, need their iron levels replenished more quickly.

In these cases, injectable forms of iron can provide a treatment alternative. The FDA approved Injectafer in 2013 for the treatment of iron deficiency anemia, but with a restriction—it could be used only in adult patients who either could not tolerate oral iron supplements, who had not had a good response to them, or who had non-dialysis chronic kidney disease.

Yet the video, according to the FDA, implied that the treatment could be applied to “all” patients, which goes against the restricted approval.

FDA Points Out Misleading Statements About Injectafer

The FDA took issue with a couple statements the manufacturers made in the video. According to the letter, they were as follows:

  • “In the United States, an estimated 7.5 million people suffer from iron deficiency anemia or IDA and well over one-third of those with IDA are women and children.”
  • “Well, it’s called Injectafer, or ferric carboxymaltose. It’s the first IV iron approved in the U.S. for patients with iron deficiency anemia caused by any disease. In fact, it’s also used for patients who are intolerant of oral iron or where oral iron is unsatisfactory and it’s also approved in adult patients in non-dialysis chronic kidney disease.”

These statements, the FDA said in their letter, were misleading “because they suggest that Injectafer is used to treat all patients, including children, with iron deficiency anemia (IDA), regardless of concomitant disease or prior treatment, in addition to the two limited subsets of patients specified later in the claim.” (Emphasis the FDA’s.)

They went on to say that Injectafer’s use is limited only to the populations mentioned in the restriction and that the product labeling “does not provide instructions for, or otherwise indicate that Injectafer will be safe and effective for all IDA patients.” They also noted that the video minimized the risks of Injectafer, presenting them only in a quick, 30-second text segment that was difficult to read because of the small type.

Injectafer Downplays Serious Risks

There were more things about the ad that the FDA took issue with, including misleading statements made in dialogue that made it seem like Injectafer could improve the general well-being of the patient, and implying that the treatment offered advantages over other competitive products when there was no evidence of such advantages.

In fact, recent studies have found evidence of the opposite—that Injectafer can increase the risk of hypophosphatemia (a deficiency of phosphate) and severe hypophosphatemia more than other injectable iron products.

In 2016, for example, researchers compared the iron used in Injectafer (FCM) with the iron used in a competing product, Monofer (iron isomaltoside) in patients with iron deficiency anemia. They found that those injected with FCM had a 45.5 percent risk of hypophosphatemia, compared to only a four percent risk in those taking iron isomaltoside. Further, those taking FCM were at a 32.7 percent risk of severe hypophosphatemia—while none of the patients treated with iron isomaltoside suffered from this more dangerous condition.

The FDA asked the manufacturer to “cease violating the FD&C Act” with the video and to ensure that their future advertisements complied with regulations.

Injectafer’s manufacturer has so far failed to provide adequate warnings about the risk of severe hypophosphatemia associated with Injectafer.

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