Bio-Identical Hormone therapy has been absolutely life changing for hundreds of my clients. The symptoms of fatigue, insomnia, hot flashes, night sweats, weight gain etc. can be debilitating if left untreated. Occasionally, candidates for bio-identical hormone treatment are apprehensive about starting treatment because the Bio-Identical Sottopelle Hormone Treatment is not FDA approved. Here is some information on what FDA approval means and what it guarantees.
What does FDA approval mean? FDA approval is granted after a drug has gone through rigorous clinical trials to prove its safety and efficacy for a specific treatment. But is this really true? Let’s take a look at the drug Premarin (synthetic conjugated estrogen derived from a pregnant horses’ urine) which was placed on the market in 1942. It became the most frequently dispensed drug in the United States between 1990-1995, regardless of multiple studies through the late 1980’s proving this drug placed women at an increased risk for heart attacks, stroke and breast cancer. Over 13 years later in 2002, the FDA announced it will more “carefully evaluate this drug.”
What does FDA approval mean to the pharmaceutical companies? Once the drug is approved, it allows pharmaceutical companies to market the drug for the approved condition to recoup cost of research and testing.
FDA Approval does not ensure everyone who takes the drug will benefit from it.
For a clinical trial to be considered successful, it is not necessary for everyone to experience positive effects. Some drugs receiving FDA approval do not even have the majority of patients in the research trial experience a positive improvement. The criteria for approval of the drug, is based on the patients in the research trial having “clinically significant” improvement as compared to those receiving a placebo. There is no set criteria for a percentage or specific number that must be obtained to make it clinically significant.
FDA Approval does not assure that patient will not suffer side effects from taking the drug. Package inserts list many side effects.
FDA Approval does not guarantee that the medication prescribed will be used for the same indication (treatment) that was researched in the drug trial when approval was granted. Approximately 1 in 5 drugs prescribed – are prescribed as off-label usage. These drugs are being prescribed for something different than which the drug originally received FDA approval.
FDA approval does not guarantee that insurance companies will pay for the medication. Insurance companies set their own policies for what is to be covered – typi- cally based on price. Newer drugs that have no generic counterpart are usually expensive and insurance companies will often try to avoid paying for them. In addition, insurance companies sometimes use the lack of FDA approval and certain of-label prescriptions to deny claims.
Are compounded Bio-Identical Hormones unsafe because they are not FDA approved? Compounded medications are regulated by state boards of pharmacy. They are not FDA approved because FDA approval is designed to regulate mass-production of drugs. Compounded medications are specifically compounded to meet the unique needs of an individual based on the physician’s prescription. Moreover, Bio-identical hormones – like all compounded medications are made from FDA and US Pharmacopeia (USP) registered materials – the same materials used by pharmaceutical manufacturers.
Summary. Don’t let FDA approval deter you from a life changing treatment that is biologically identical to your own body’s hormones and documented to be safe and effica- cious as compared to the synthetic hormones which have received FDA Approval. Make the informed choice and live life to its fullest. You simply do not have to live life with symptoms of fatigue, increased mid section fat, hot flashes, low sex drive, decreased mental acuity, depression and more.