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If your young child uses an anti-allergenic infant formula such as Neocate, or if you or a loved one suffers from iron deficiency anemia, you should be aware of a potentially dangerous condition called hypophosphatemia (HPP).

Two popular products—Injectafer and Neocate—have been linked to HPP in adults. Those using these products should be warned about the danger, but so far, the manufacturers have failed to provide those warnings, leaving many people at risk.

What is Hypophosphatemia?

Hypophosphatemia (HPP) is a condition in which the body becomes deficient in phosphate. Symptoms vary depending on how deficient the person is. At mild levels, there may be no symptoms at all, or the patient may experience fatigue, weakness, confusion, and shortness of breath. At moderate and severe levels, however, the symptoms may be more serious and can include muscle weakness, respiratory failure, seizures, coma, and heart failure.

Phosphate is a combination of the mineral phosphorus and oxygen. When you take in phosphorus through food—via things like eggs, beans, nuts, cereal, milk, and meat—the body metabolizes it into phosphate. It then uses that phosphate for a number of activities, including building and repairing teeth and bones, producing energy, and maintaining DNA.

The body can become deficient in phosphate for many reasons, including thyroid disorders, vitamin D deficiency, kidney disease, malnutrition, alcoholism, and treatment of diabetic ketoacidosis. But recent research has revealed that certain products can cause HPP, too.

Hypophosphatemia in Infants Using Neocate

Parents who give their babies “Neocate” formula need to be alert for signs of HPP in their children. Neocate is a substitute baby formula used for babies who are allergic to regular cow’s milk and soy. It’s an anti-allergenic formula that’s considered “amino-acid-based.”

A recent study linked Neocate formula with HPP and related bone problems in babies. They found 51 children at 17 institutes who had been fed only Neocate formula and had developed HPP. The parents did not know that their children had this condition, though, until the children developed either bone fractures or rickets (a disease caused by vitamin D deficiency).

Initially, doctors were confused. They thought the fractures were caused by something else, but all of the children improved when they were given supplemental phosphate. The researchers concluded that the children were deficient in phosphate because of Neocate, and that when they were transferred to another formula, they improved quickly. They recommended that children fed formulas like Neocate should be carefully monitored for low levels of phosphate.

Hypophosphatemia in Iron Deficiency Anemia Patients Receiving Injectafer

Iron deficiency anemia is a type of anemia caused by an iron deficiency. The body needs iron to produce “hemoglobin,” which is critical for getting oxygen to the organs and tissues that need it. If a person is low on iron, symptoms may include weakness, shortness of breath, and pale skin, among others.

The condition is usually treated with an oral iron supplement, but some patients cannot tolerate it or don’t have good results from it. For these patients, doctors usually recommend iron injections. There are many forms available. One of them is called “Injectafer.” It is one of the most popular because it works quickly. Patients can take two doses separated only by seven days and experience significant improvements in iron levels.

Yet Injectafer, more than other injectable iron supplements, has been linked with a risk of both HPP and severe HPP. Injectafer uses a form of iron called ferric carboxymaltose (FCM). In a 2015 study, researchers found that only 22 percent of patients treated with iron sucrose developed HPP, but 51 percent of those treated with FCM did. In a 2016 study, they found similar results. Those taking FCM were at a 45.5 percent increased risk for HPP, compared to only a four percent risk for those taking another form of iron (iron isomaltoside).

Watch for Signs of Hypophosphatemia

If you have a baby using Neocate, or if you have iron deficiency anemia and may be treated with an iron injection, ask your doctor about the risks, and find out if there may be safer alternatives for you or for your baby.

Meanwhile, watch for early signs of hypophosphatemia, which may include:

  • Muscle weakness
  • Bone pain; fractures
  • Tingling, numbness, tremors
  • Arrhythmias
  • Trouble breathing; shortness of breath
  • Confusion
  • Delirium
  • Seizures
  • Coma

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