You may have heard that Trimix injectables, like many other compounded medications, are not evaluated by the FDA or are used off-label. What does this mean? Are Trimix injections safe? Injectable medications have been used since 1983 to treat ED and are considered the most effective non-surgical solution for ED, according to the American Urological Association (American Urological Association, 2018).

What Makes Up Trimix Injectables?

Trimix is a combination of three medications: papaverine, phentolamine, and alprostadil. Papaverine is a medication that relaxes the smooth muscles in blood vessels and causes them to dilate or widen so blood can flow through them more easily. Papaverine is used to treat chest pain from spasms in blood vessels in the heart, heart disease, and blood vessel problems. Papaverine is also used to increase blood flow into the penis as a treatment for erectile dysfunction.

Phentolamine also causes relaxation of the smooth muscles in blood vessels and increases blood flow. It is used to treat high blood pressure and to treat ED by increasing blood flow as well.

Alprostadil is an FDA approved medication to treat ED. The three medications act synergistically to get the best results with the fewest side-effects. The combined effect of all three medications is to increase blood flow into the corpus cavernosum and cause an erection.

So while the FDA has not evaluated and approved Trimix as a compounded medication used to treat ED, physicians have prescribed the three medications that comprise Trimix to treat several medical conditions, and patients can purchase Trimix injections for Erectile Dysfunction. The compound, Trimix injections, has been used safely for decades.

What Is Pharmaceutical Compounding?

The U.S. Food and Drug Administration states that pharmaceutical compounding is the “combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription.” The FDA routinely collects samples of compounded medications from pharmacies and checks them for:

• Sterility: Are there any contaminants in the compound?
• Identity: Are the medications in the compound correctly identified?
• Assay (potency): Are the medications’ strengths as it lists them in the USP Monograph?
• Endotoxins: An endotoxin test checks for the presence of any endotoxins in the sample. Endotoxins are found in the walls of gram-negative bacteria.
• Particulates: Particulate testing is to see if any compounds settle out of the solution.
• Release rate: The rate at which a drug is released from a compounded preparation.
• pH: Measures the acidity of a compound or medication.
• Microbial limits: Measures how many and which kinds of microorganisms are present in a non-sterile preparation.
• Contaminants: Are there any contaminants found in the preparation?
• Dissolution: Dissolution testing measures the extent and rate of solution formation from a dosage form.
• Content uniformity: Measures how well the components making up the compound mix.

Samples of the products were collected from compounding pharmacies and tested. The results for Trimix injections showed that it passed all tests. To ensure that Trimix injection, a compounded medication, is safe and effective, it requires a prescription. Men should fill the prescription at a 503B compliant compounding facility using pharmaceutical grade medication components.

What Does It Mean For A Drug, Such As Trimix Injections, To Be Used Off-Label?

The FDA does not regulate the practice of medicine, so it is not unusual for medications to be used off-label. Off-label use of medications is used in all fields and specialties of medicine, but is more common in patient populations that are frequently not included in clinical trials. Pharmaceutical companies are not permitted to market their medications for off-label use. Physicians weigh the potential risks and benefits of each medication and decide based on what is in the best interests of their patients (Wittich et al., 2012).

Off-Label Drug Use Is Very Common

Off-label drug use is very common. In a 2006 study, 21.6 percent of the medications were being used off-label (Radley et al., 2006). Off-label use can be so common that the medication is more commonly used to treat its off-label medical condition than the disorder that it was initially formulated and tested to treat (Wittich et al., 2012).

What Does “Safe” Mean?

For a drug to be FDA approved, the manufacturer must submit clinical data showing the safety and effectiveness of the medication to the FDA for review. Safe does not mean that the medication has no side effects. Safe means that the benefits of the medication outweigh the potential risks. The FDA recommends that before you use a medication; you ensure that it meets the following three conditions:

• The FDA has evaluated the risks and benefits of the medication
• The decision to use the drug is supported by strong scientific data.
• Health care providers provide patients with the necessary information to take the product safely and effectively for the condition they are treating (US. FDA, 2018).

Drugs are used off-label when it is medically appropriate for the user. Researchers have found the three medications that make up Trimix injections to be safe and effective in selected patients for ED treatment. A prescription is required to verify that for an individual patient, the benefits of Trimix injections outweigh any potential risks and that the patient does not have any confounding medical problems that may increase their risks (US. FDA, 2018).

According to the FDA, health care providers should provide information on the specific diseases and conditions that the drug is being used to treat, who the drug should or should not be used for, information about the risks and benefits of using the medication, and information that should be discussed with the patient before the drug is used.

Trimix Injections: Safety And Efficacy

Knowing that off-label use of medication is not unusual and is widely accepted as long as the physician believes that the potential benefits outweigh the risk for the person taking the medication, the off-label use of Trimix injections is not unusual or concerning when evaluating its safety profile.

The fact that Trimix is a compounded medication is also not concerning. In fact, when the FDA ran tests on a sample of Trimix, it passed all clinical tests. The most important safety factor for compounded medications is to ensure they are filled in a 503B compliant pharmacy.

Mentioned Product

Trimix Injections

Trimix Injections are used as a second-line treatment when oral ED medications don’t work.

Learn About Trimix Injections

The Safety And Efficacy Of Trimix Injections

The final consideration for safety and efficacy is whether the use of Trimix injections to treat ED is backed by strong clinical evidence. Trimix has proven to be 80% effective for helping men with ED maintain an erection long enough to have sex (Coombs et al., 2012). Trimix has been labeled as safe and effective for the treatment of ED, except in men who are allergic to any of its components, have a condition that predisposes to priapism (prolonged erection), have an anatomical deformity of the penis, or are taking any medications that interfere with blood clotting (McVary, 2010).

The American Urological Association urges men to take ED seriously, as it can be a warning sign of future cardiovascular disease. They recommend that all ED treatment options be considered and discussed with men to determine which class of medications has the best risk versus benefits profile. When reviewed for side effects, men who injected Trimix had the following adverse events:

• Pain with injection 2.02%
• Injection site bruise or swelling 14.83%
• Penile fibrosis 4.53%
• Prolonged or painful erection 2.80%
• Priapism 3.15%

To minimize the risks of these side effects, apply pressure at the injection site for five minutes to decrease the risk of bruising or swelling. Strictly follow dosing guidelines and alternate which side of the penis is injected to decrease the risk of fibrosis. Discuss the risk of priapism with your health care provider and ensure that you have a plan for treatment if it should occur (American Urological Association, 2018). Overall, researchers have found Trimix injections to be safe and effective. Patients can rest assured that if they buy trimix from a compounding pharmacy, with a doctors prescription, that the product is generally safe. Understanding how the medication works and how to prevent side-effects can decrease risk even further.

DISCLAIMER

While we strive to always provide accurate, current, and safe advice in all of our articles and guides, it’s important to stress that they are no substitute for medical advice from a doctor or healthcare provider.  You should always consult a practicing professional who can diagnose your specific case.  The content we’ve included in this guide is merely meant to be informational and does not constitute medical advice. 

References:

1. American Urological Association. (2018). Erectile Dysfunction: AUA Guidelines. Retrieved from https://www.auanet.org/guidelines/erectile-dysfunction-(ed)-guideline#x8050
2. The U.S. F.D.A. (2018). Understanding unapproved use of approved drugs “off label.” Retrieved from https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
3. Wittich, C. M., Burkle, C. M., & Lanier, W. L. (2012). Ten common questions (and their answers) about off-label drug use. Mayo Clinic Proceedings, 87(10), 982–990. https://doi.org/10.1016/j.mayocp.2012.04.017
4. Radley D.C., Finkelstein S.N., Stafford R.S. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021–1026. https://pubmed.ncbi.nlm.nih.gov/16682577/
5. Coombs, P. G., Heck, M., Guhring, P., Narus, J., & Mulhall, J. P. (2012). A review of outcomes of an intracavernosal injection therapy programme. BJU International, 110(11), 1787–1791. https://pubmed.ncbi.nlm.nih.gov/22564343/#:~:text=Conclusions%3A%20%E2%80%A2%20ICI%20therapy%20is,the%20third%20year%20are%20significant.&text=Of%20note%2C%20the%20recorded%20priapism,was%20extremely%20low%20(0.5%25).
6. McVary, K. (2010). Contemporary Treatment of Erectile Dysfunction: A Clinical Guide. United Kingdom: Humana Press. https://link.springer.com/book/10.1007/978-3-319-31587-4?noAccess=true

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