Testosterone is a hormone that is produced naturally in human bodies. Male bodies produce more and female bodies much less. Testosterone injections are used legitimately to treat certain medical conditions in men. The Food and Drug Administration (FDA) has not approved testosterone preparations for any use in women. So if a doctor prescribes testosterone for a woman, it is for an off-label use.
In the U.S. before the FDA approves any drug for use in patients, the company that manufactures the drug must submit clinical data and other information to the FDA for review and approval. The data from studies must show that the drug is both safe and effective for its intended uses. A safe drug may still have adverse side effects, but if the FDA approves it, it means that the FDA believes that the benefits of administering the drug for a particular use outweigh the potential risks.
If a drug is used “off-label”, this means that it is being used to treat a condition for which it has not been tested and approved by the FDA. So, importantly, the effectiveness of the use for an off-label purpose has not been proven by clinical studies. In addition, it means that there are no studies that establish the proper dosage of the substance for treating the off-label condition. A person may still experience side-effects if they use the medication, but they cannot know with any degree of certainty that they are experiencing the benefits as well.
There is some research showing that testosterone may improve sexual function in specific groups of women. However, data on the safety and effectiveness of testosterone use in women are limited. Experts note that the long-term safety of testosterone therapy for women also is unknown.
Given the fact that research on the safety and effectiveness of testosterone use for treating women is limited and the number of potential serious side effects well known, testosterone is not commonly used to treat sexual dysfunction in women. Again, the FDA has not approved testosterone for the treatment of any condition in women, so using testosterone to treat a woman would be an off-label use.
Health care professionals especially caution women that testosterone can harm an unborn baby. A woman who is pregnant should not use it. Rather, a woman should use effective birth control if they are using testosterone. Whether testosterone passes into breast milk is not known. It is also not known if it could cause harm to a baby who is nursing, so a woman should not breastfeed while using testosterone.
The condition of low testosterone is diagnosed by a health care professional through a blood test. Treatment for low testosterone would then be administered by a physician and monitored by the physician, because there can be side effects, some of which cannot be reversed. And, again, treatment of any condition in a woman with testosterone would be off-label and not approved by the FDA
Men and boys with conditions caused by a lack of testosterone, such as delayed puberty or growth, are treated with testosterone as a gel, patch or injection. It is only recommended for males with a diagnosed medical condition, such as a genetic disorder, problems with certain organs that regulate hormones, such as the hypothalamus and pituitary, or previous chemotherapy. In women, reportedly doctors use testosterone to treat certain types of breast cancer, specifically if it has spread to other parts of the body.
Medical authorities say that testosterone should not be used to enhance athletic performance. It is not approved by the FDA to treat normal male aging. It is used “off-label” to treat gender dysphoria.
What Are Some Issues with Low Testosterone Treatments for Women?
Side effects of testosterone treatments for women generally have to do with the side effects of testosterone in men. Some of the side effects that a woman might experience could include:
- Development of male pattern baldness;
- Male pattern hair growth, e.g. growth of facial hair;
- Changes in menstrual cycles;
- Changes in lipid profiles: a lipid profile is a blood test, used primarily to identify cholesterol levels, because elevated cholesterol can indicate a risk of heart disease;
- Increased risk of heart disease.
Certain companies have capitalized on the popularity of testosterone supplements and have marketed various treatments, therapies, and drugs that are intended to balance women’s testosterone and estrogen. Many unsafe and untested products are readily available for purchase by the public. They are dangerous drugs promoted by the idea that women need to raise their testosterone levels.
In addition, women diagnose their own condition as one involving low testosterone and do not seek the guidance of a physician. They then attempt to treat their condition themselves with unsafe, untested products. This is ill-advised.
Testosterone has been used to treat reduced testosterone levels in males which develops as a result of aging. Many men suffered heart attacks, embolisms and strokes as a consequence of this off-label use of testosterone and thousands of lawsuits against the manufacturers of testosterone therapy replacement products resulted.
Nearly 7,000 lawsuits were filed by men who claimed they were injured by using testosterone replacement supplements, 4,500 of them involved a product called AndroGel that was produced by the pharmaceutical company, AbbVie, which led the market in sales of testosterone supplements. The lawsuits were consolidated in federal court in Illinois where many trials took place and settlements were reached.
Lawsuits involving victims who mostly suffered heart attacks while using testosterone off-label were successful against the manufacturers for negligent misrepresentation, but not strict product liability or fraudulent misrepresentation. The lawsuits have generally not alleged malpractice or negligence on the part of physicians.
The testosterone lawsuit alleged that products marketed as “Low T” substances meant to increase testosterone levels in men, had the effect of increasing the risk of heart attacks, strokes, and blood clots; and that the manufacturers misled the public regarding the benefits and risks of these products with misleading marketing
Clinical research studies have been done which show that the risk of a heart attack or stroke for a user of testosterone replacement products is double that of a person who does not use these products. Still, the products can be easily obtained and manufacturers have simply added additional warnings to their package labels. The Abbvie company, for example, lists an increased risk of heart attack, pulmonary embolism, and stroke on its label for its product marketed as “AndroGel.” The supplements have not been recalled by the FDA.
Are There Legal Issues Associated with Low Testosterone Treatments for Women?
As noted there have been lawsuits in which men who used testosterone products and suffered heart attacks and pulmonary embolism alleged a variety of claims, including:
Reports on lawsuits filed by women for injury from testosterone use are not reported in the literature.
Do I Need a Lawyer for Help with Testosterone Product Lawsuits?
Low testosterone can be an actual medical condition in women that requires the attention of a licensed physician. However, it is not a common condition and is especially uncommonly verified in women. It is possible that it is a condition promoted by the manufacturers of testosterone supplements for the purpose of increasing sales.
If you have taken testosterone supplements and experienced unwanted or possibly harmful side-effects, you may wish to consult a personal injury lawyer. Your lawyer can enlist the aid of medical experts who can tell whether your side-effects might be related to your testosterone use. If they are, then your lawyer can identify the legal theories that might support a lawsuit against the manufacturer of the supplement or any physician who may have prescribed the medication for you.
You probably should not guess about your medical conditions and prescribe treatments for yourself; similarly, you should also not guess about whether you have a case against a doctor or drug manufacturer. It is best to get an expert opinion from an experienced personal injury lawyer.