FDA Warning Letter Slammed Injectafer Advertising Video’s Misleading Claims

Published on May 7, 2019 by Sandy Liebhard

An early Injectafer advertising campaign wasn’t well-received at the U.S. Food & Drug Administration (FDA), judging from a January 2015 Warning Letter.

Injectafer and Anemia

Injectafer (ferric carboxymaltose injection) is an intravenous medication that treats adults suffering from iron deficiency anemia, a disorder that affects roughly 1 billion people throughout the world.

The FDA initially declined to approve the medication in 2008, after clinical trials flagged “excess mortality and severe hypophosphatemia” (dangerously low serum phosphorus levels) as potential Injectafer side effects. Although the agency finally granted approval in 2013, it stipulated that Injectafer infusions be reserved for adult patients who either:

• Can’t tolerate oral iron supplements;
• Didn’t adequately respond to oral iron; or
• Have non-dialysis dependent chronic kidney disease.

Injectafer Advertising: What’s the Problem?

As part of a 2014 Injectafer advertising campaign, Luitpold Pharmaceuticals released a promotional video that aired during Lifetime TV special called “The Balancing Act”. The FDA’s subsequent Warning Letter took issue with two specific statements from the video’s script:

• “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.”

According to the agency, the above statements implied that Injectafer was appropriate for all patients suffering from iron deficiency anemia, even children. But as noted above, the FDA restricted Injectafer to three very specific adult patient populations. While it’s true that doctors are free to prescribe approved drugs in any manner they deem appropriate, pharmaceutical companies are prohibited from promoting their products for “off-label” uses that haven’t received the FDA’s endorsement.

The letter further noted that the Injectafer advertising video did “not provide instructions for, or otherwise indicate that Injectafer will be safe and effective for all IDA patients.” And it criticized its presentation side effect information in a quick, 30-second text segment that was difficult to read because of the small type.

Injectafer Hypophosphatemia Lawsuits

According to the FDA Warning Letter, the most common adverse reactions reported among Injectafer patients include nausea, hypertension, flushing, hypophosphatemia, and dizziness.

In the years since the Injectafer advertising controversy, evidence linking the anemia treatment to a severe and persistent form of hypophosphatemia has only grown. Yet the Injectafer label barely mentions this possible side effect, suggesting only that patients might experience transient decrease in serum phosphorus levels following an infusion.

The first Injectafer lawsuit alleging severe hypophosphatemia was actually filed last January in the U.S. District Court, Easter District of Pennsylvania. Several other cases were brought in the ensuing months, indicating that the litigation could eventually grow to include hundreds of similar claims.

What is Hypophosphatemia?

Healthy adults generally have serum phosphorus levels ranging from 2.5-4.5 mg/dL.

While it’s true that a mild phosphorus deficiency often presents with few, if any, symptoms, some Injectafer patients have allegedly experienced persistant phosphorus drops below 1mg/dL. A deficiency that serious may cause:

• Muscle weakness
• Fatigue
• Bone pain
• Bone fractures
• Loss of appetite
• Irritability
• Numbness, tingling, or tremors
• Confusion

Left untreated, severe and persistent hypophosphatemia may lead to respiratory failure, muscle weakness, cardiac arrest, seizures, coma, and even death.