What Are Bioidentical Hormones? Safety and Uses
The FDA has not approved all bioidentical hormone products, but those that have been approved have undergone extensive testing and quality control. However, there are many products on the market that have not been evaluated by the FDA and have not been tested for safety or effectiveness.
These products are sold by companies that are not registered with the FDA. This leaves a confusing marketplace with some well-tested products and others that may carry unknown risks. There are no long-term studies that have been done to determine the long-term effects of bioidentical hormones.
Compounded bioidentical hormones have not been tested and approved by the FDA
Bioidentical hormones are manufactured in labs from plants and animal sources and have the same chemical composition as the hormones in the human body. They are sold as pharmaceuticals and as compounded preparations. Some of the more popular compounded formulations contain hormones that are derived from natural sources. Advocates of bioidentical hormones claim that these products are safer and more effective than pharmaceuticals.
However, bioidentical hormones must be chemically modified in a laboratory before they are given to a patient.
The FDA requires pharmaceutical companies to report any side effects of their drugs. However, compounding pharmacies do not have to report side effects. As a result, patients are not guaranteed the potency and quality of compounded hormones. There are also risks of overdose.
They may not be better or safer than FDA-approved therapies
In January 2008, the FDA notified seven pharmacy operations that their products did not meet the FDA’s safety and efficacy standards. They also stated that the mixtures sold by these operations had not been thoroughly tested for efficacy, potency, or purity. As a result, there was no way to ensure that they were safe for human consumption.
There are two major types of bioidentical hormones, namely compounded and pre-made. The former has been manufactured by a pharmaceutical company, while the latter is made by a pharmacist.
Both are advertised as safer, more effective, and more natural alternatives to conventional hormone therapy. While custom-made bioidentical hormones may be beneficial for some patients, many providers are concerned about their safety.
They are absorbed rather than swallowed
Bioidentical hormones are a form of hormone replacement therapy that is absorbed rather than swallowed. Because these hormones are absorbed in the body, they are more easily used.
The process of hormone replacement therapy can be titrated to meet the specific needs of each person. In fact, many formulary pharmacists work with physicians to formulate customized hormone replacement plans for their patients. They can also provide valuable information about compounded hormones.
The major advantage of bioidentical hormones over other methods of hormone replacement is that they have the same chemical structure as the hormones produced in the body. This means that they can minimize negative side effects while boosting your body’s hormone levels.
However, few studies have been conducted to compare bioidentical hormones to non-bioidentical preparations. As a result, there is little evidence available to draw definite conclusions …