Prasterone Dehydroepiandrosterone Dietary Supplements

What is Prasterone Dehydroepiandrosterone Dietary Supplements

Dehydroepiandrosterone (DHEA), also known as prasterone, is a C19 steroid also known as 5-androsten-3 beta-ol-17-one. DHEA and DHEAS (an active, sulfated form of DHEA), are endogenous hormones secreted by the adrenal cortex in primates and a few non-primate species in response to ACTH.

DHEA is a steroid precursor of both androgens and estrogens.

Synthetic DHEA is marketed as a dietary supplement. There is currently no objective, well-controlled, large-scale, scientific evidence to back claims that taking DHEA combats the signs or symptoms of aging, diabetes, neurologic disease, sexual dysfunction, or heart disease.

Some athletes abuse DHEA believing that it can enhance the body’s synthesis of testosterone; the potential action of DHEA as an anabolic steroid has lead to the prohibition of supplementation in competitive sport, even though evidence of anabolic effects in athletes is lacking.

DHEA is also abused by athletes in an attempt to normalize the testosterone:epitestosterone ratio.

However, the sensitivity and specificity of currently available testing for athletic ‘doping’ can readily identify the presence of banned substances, including testosterone.

Many of the trials of DHEA supplementation to date have lacked the rigor and statistical applications needed to support therapeutic claims.

In 1984, the FDA banned the non-prescription (OTC) sale of exogenous DHEA due to concern over hepatotoxicity (hepatitis and hepatic tumors) noted in animal studies.

The FDA formally relegated DHEA to a Category II OTC ingredient at that time (i.e., not generally recognized as safe and effective, or “not GRAS”).

However in 1994, the passage of the US Dietary Supplement Health and Education Act (DSHEA) allowed DHEA to be marketed as a nutritional or dietary supplement.

Several prasterone (DHEA) proprietary products have sought FDA-approval. An NDA was submitted in the year 2000 for a proprietary prasterone product (Prestara, formerly known Aslera or GL-701), for patients with mild-to-moderate systemic lupus erythematosus (SLE); however, the FDA issued a ‘not approvable’ letter since thetrial data for SLE did not meet the primary end point.

Now known as Prastera Kit, this prasterone dietary supplement is packaged with ibuprofen, but the prasterone within the kit is NOT an FDA-approved drug product.

In August 2003, Paladin Labs Inc., received orphan drug designation from the FDA for dehydroepiandrosterone (DHEA), under the brand name Fidelin, for replacement therapy in patients with adrenal insufficiency; however, the product remains investigational for this use and is not FDA-approved.

Indications

  • andropause
  • erectile dysfunction (ED)
  • systemic lupus erythematosus (SLE)

For the adjunctive treatment of mild-to-moderate systemic lupus erythematosus (SLE)† in adult women

Side Effects

  1. abdominal pain
  2. acne vulgaris
  3. acneiform rash
  4. amenorrhea
  5. breast discharge
  6. breast enlargement
  7. clastogenesis
  8. clitoromegaly
  9. dysmenorrhea
  10. elevated hepatic enzymes
  11. emotional lability
  12. fatigue
  13. fluid retention
  14. galactorrhea
  15. gynecomastia
  16. headache
  17. hepatitis
  18. hirsutism
  19. hoarseness
  20. insomnia
  21. jaundice
  22. libido increase
  23. mania
  24. menstrual irregularity
  25. nasal congestion
  26. nausea
  27. new primary malignancy
  28. peripheral edema
  29. teratogenesis
  30. vaginal bleeding
  31. virilization
  32. vomiting

Monitoring Parameters

  • LFTs
  • pap smear
  • prostate-specific antigen (PSA)

Contraindications

  • acquired immunodeficiency syndrome (AIDS)
  • bipolar disorder
  • breast cancer
  • breast-feeding
  • children
  • diabetes mellitus
  • endometrial cancer
  • endometrial hyperplasia
  • erectile dysfunction (ED)
  • G6PD deficiency
  • hepatic disease
  • hepatocellular cancer
  • human immunodeficiency virus (HIV) infection
  • infertility
  • jaundice
  • labor
  • mania
  • ovarian cancer
  • porphyria
  • pregnancy
  • prostate cancer
  • prostatic hypertrophy
  • soya lecithin hypersensitivity
  • surgery
  • uterine cancer
  • vaginal bleeding
  • vaginal cancer

Interactions

  • Abarelix
  • Acarbose
  • Acetaminophen; Aspirin, ASA; Caffeine
  • Alogliptin
  • Alogliptin; Metformin
  • Alogliptin; Pioglitazone
  • Alpha-glucosidase Inhibitors
  • Alprazolam
  • Amitriptyline; Chlordiazepoxide
  • Anastrozole
  • Anticoagulants
  • Antithrombin III
  • Apixaban
  • Argatroban
  • Aromatase Inhibitors
  • Aspirin, ASA
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Aspirin, ASA; Caffeine; Dihydrocodeine
  • Aspirin, ASA; Caffeine; Orphenadrine
  • Aspirin, ASA; Carisoprodol
  • Aspirin, ASA; Carisoprodol; Codeine
  • Aspirin, ASA; Citric Acid; Sodium Bicarbonate
  • Aspirin, ASA; Dipyridamole
  • Aspirin, ASA; Omeprazole
  • Aspirin, ASA; Oxycodone
  • Aspirin, ASA; Pravastatin
  • Azelastine; Fluticasone
  • Beclomethasone
  • Benzodiazepines
  • Betamethasone
  • Betrixaban
  • Bivalirudin
  • Budesonide
  • Budesonide; Formoterol
  • Budesonide; Glycopyrrolate; Formoterol
  • Canagliflozin
  • Canagliflozin; Metformin
  • Cetrorelix
  • Chlordiazepoxide
  • Chlordiazepoxide; Clidinium
  • Ciclesonide
  • Clomiphene
  • Clonazepam
  • Clorazepate
  • Conjugated Estrogens
  • Conjugated Estrogens; Bazedoxifene
  • Conjugated Estrogens; Medroxyprogesterone
  • Corticosteroids
  • Cortisone
  • Cyclosporine
  • Dabigatran
  • Dalteparin
  • Danaparoid
  • Dapagliflozin
  • Dapagliflozin; Metformin
  • Dapagliflozin; Saxagliptin
  • Darbepoetin Alfa
  • Deflazacort
  • Degarelix
  • Desirudin
  • Dexamethasone
  • Diazepam
  • Dienogest; Estradiol valerate
  • Diethylstilbestrol, DES
  • Dipeptidyl Peptidase-4 Inhibitors
  • Drospirenone; Estradiol
  • Drospirenone; Ethinyl Estradiol
  • Drospirenone; Ethinyl Estradiol; Levomefolate
  • Edoxaban
  • Elagolix; Estradiol; Norethindrone acetate
  • Empagliflozin
  • Empagliflozin; Linagliptin
  • Empagliflozin; Linagliptin; Metformin
  • Empagliflozin; Metformin
  • Enoxaparin
  • Epoetin Alfa
  • Ertugliflozin
  • Ertugliflozin; Metformin
  • Ertugliflozin; Sitagliptin
  • Estazolam
  • Esterified Estrogens
  • Esterified Estrogens; Methyltestosterone
  • Estradiol
  • Estradiol Cypionate; Medroxyprogesterone
  • Estradiol; Levonorgestrel
  • Estradiol; Norethindrone
  • Estradiol; Norgestimate
  • Estradiol; Progesterone
  • Estrogens
  • Estropipate
  • Ethinyl Estradiol
  • Ethinyl Estradiol; Desogestrel
  • Ethinyl Estradiol; Ethynodiol Diacetate
  • Ethinyl Estradiol; Etonogestrel
  • Ethinyl Estradiol; Levonorgestrel
  • Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
  • Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
  • Ethinyl Estradiol; Norelgestromin
  • Ethinyl Estradiol; Norethindrone
  • Ethinyl Estradiol; Norethindrone Acetate
  • Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
  • Ethinyl Estradiol; Norethindrone; Ferrous fumarate
  • Ethinyl Estradiol; Norgestimate
  • Ethinyl Estradiol; Norgestrel
  • Exemestane
  • Fludrocortisone
  • Flunisolide
  • Flurazepam
  • Fluticasone
  • Fluticasone; Salmeterol
  • Fluticasone; Umeclidinium; Vilanterol
  • Fluticasone; Vilanterol
  • Fondaparinux
  • Formoterol; Mometasone
  • Ganirelix
  • Glipizide; Metformin
  • Glyburide; Metformin
  • Goserelin
  • Heparin
  • Histrelin
  • Hydrocortisone
  • Incretin Mimetics
  • Insulins
  • Lepirudin
  • Letrozole
  • Leuprolide
  • Leuprolide; Norethindrone
  • Linagliptin
  • Linagliptin; Metformin
  • Lorazepam
  • Meglitinides
  • Mestranol; Norethindrone
  • Metformin
  • Metformin; Pioglitazone
  • Metformin; Repaglinide
  • Metformin; Rosiglitazone
  • Metformin; Saxagliptin
  • Metformin; Sitagliptin
  • Methoxy polyethylene glycol-epoetin beta
  • Methylprednisolone
  • Midazolam
  • Miglitol
  • Mometasone
  • Nafarelin
  • Oxazepam
  • Pentosan
  • Platelet Inhibitors
  • Pramlintide
  • Prednisolone
  • Prednisone
  • Progestins
  • Quazepam
  • Ribociclib; Letrozole
  • Rivaroxaban
  • Saw Palmetto, Serenoa repens
  • Saxagliptin
  • Segesterone Acetate; Ethinyl Estradiol
  • SGLT2 Inhibitors
  • Simvastatin; Sitagliptin
  • Sitagliptin
  • Sulfonylureas
  • Temazepam
  • Thiazolidinediones
  • Tinzaparin
  • Triamcinolone
  • Triazolam
  • Triptorelin
  • Warfarin
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