Problems observed after bowel surgery
Low potassium, a mineral in the blood, was more common in the ipamorelin group. So were trouble sleeping and high blood sugar when people left hospital.
Those findings came from adults receiving ipamorelin into a vein after major bowel surgery.
Two people receiving ipamorelin died after complications of cancer surgery.
The FDA could not tell whether ipamorelin contributed to the deaths, but said the findings raised safety concerns.
What we do not know about injections under the skin
In its review, the FDA found no human safety data for ipamorelin injected under the skin.
It also raised concerns that injected ipamorelin could make the body attack the injected material. Clumps of peptide, meaning short chains of protein building blocks stuck together, or unwanted material in the product could trigger this reaction.
Ask your clinician—the health professional treating you, such as a doctor—what the missing studies leave unknown. Ask what they would do if a problem arose.
Other risks the FDA is concerned about
A hormone is a substance that sends signals inside the body. Growth hormone is the signal ipamorelin prompts the body to release.
The following concerns come from the medical information for growth hormone drugs. They have not been proven in ipamorelin users.
The FDA is concerned that raised growth hormone could bring risks such as high blood sugar, fluid build-up or tumours.
Take your health history into that conversation, including concerns that feel unrelated.