FDA study suggests compounded hormones are risky, concerning patients, pharmacists

COBB COUNTY, Ga. — A warning to women who rely on compounded hormones to deal with menopause and other health issues: A study shows the drugs are risky because they’re not regulated by the Food and Drug Administration.

Channel 2′s Chris Jose found out the FDA funded the report and spoke to patients and pharmacists who are pushing back.

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Carolyn Boldt is 64-years old and works full-time.

“It allows me to live the life that I want to live,” Boldt said.

When she’s not in the office, Boldt spends every minute she can with her grandchildren.

“I am healthier than most people than I know at 64 years old,” she said.

Boldt credits an active lifestyle and compounded bioidentical hormones. She’s taken it for nearly two decades to help fight off debilitating effects that come with menopause. Her doctor prescribes the drugs every six months.

“I want the opportunity; I want the options to stay in a perfectly balanced set of hormones for me, and I don’t think that should be taken away,” she said.

Pharmacists at Innovation Compounding in Kennesaw showed Jose some samples.

Pharmacist Tara Thompson said compounded bioidentical hormones come in different forms, including topical solutions.

“It could contain estrogen, progesterone, testosterone, there’s several different hormones that the body makes,” Thompson said.

The FDA says the customized compounded products are a public health concern and pointed to a National Academies of Science, Engineering, and Medicine study it funded.

Researchers said, “there is insufficient evidence to support the overall clinical utility of compounded bioidentical therapy as treatment for menopause.”

Thompson argues compounded hormones are highly regulated by each state’s board of pharmacy and accreditation companies.

“The FDA has constantly been threatening to take away medications from compounding pharmacies because they do not go through the rigorous, clinical trials and FDA approval process that a regular drug does,” Thomas said.

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The study found minimal oversight and recommended the drugs be restricted to patients with a documented allergy to an active ingredient from an FDA-approved product or a documented requirement for a different dosage.

Shawn Hodges is board chair for The Alliance for Pharmacy Compounding.

He’s urging lawmakers to stop any restrictions the FDA is considering.

“The position that the FDA took was that, because none of these are approved by the FDA, it’s safe to assume they’re a risk to the general public. We disagree,” Hodges said. “We do not need the FDA to insert itself in the practice of medicine. This is really about the physician or the doctor working with the patient to identify the appropriate regiment to treat the patient’s conditions.”

The FDA says it’ll work to ensure patients have appropriate access to compounded medications.

A potential federal restriction concerns Boldt.

“What would I do if this happened? What would be my options?” she said.

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Compounding pharmacies are urging patients and providers to contact their lawmakers.

The FDA says it “strives to strike a balance between preserving access to compounded drugs for patients who have a medical need for them while protecting patients from the risks.”

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