I recently spoke with Dr. Tim Donley about the growing use of compounded minocycline gels in periodontal therapy and why dentists should think twice before switching from U.S. Food and Drug Administration (FDA)-approved treatments.
Donley is a leading expert in gum disease treatment and dental implants, an international speaker, and co-author of the first textbook on modern ultrasonic periodontal therapy used in dental schools worldwide. His evidence-based, patient-centered approach has influenced diagnostic and treatment protocols in practices across the country.
Kevin Henry: Dr. Donley, we’re seeing compounded minocycline gels entering the market. What are these, and how do they differ from Arestin?
Dr. Tim Donley.
Dr. Donley: These compounded gels are prepared by compounding pharmacies and aren’t FDA-approved. Unlike Arestin, which uses microsphere technology to release minocycline over at least 14 days, these gels typically use a simple gel base that remains in the pocket for only two to three days. Without sustained release, the antibacterial effect is much shorter. And, critically, there are no peer-reviewed clinical trials demonstrating these compounded gels are as safe or effective as Arestin.
Why are some dentists making the switch?
The primary driver is cost savings for the practice, as compounded versions are commonly less expensive for the practice to purchase. This isn’t due to a shortage; Arestin is readily available. It’s not based on any clinical advantage either, which raises both ethical and clinical concerns.
What’s the main regulatory difference between FDA-approved drugs and compounded drugs?
FDA-approved drugs undergo rigorous premarket review, clinical trials, and manufacturing under strict quality control. Compounded drugs aren’t reviewed by the FDA before being sold. As the FDA warns, poor compounding practices can lead to contamination, incorrect potency, and unstable formulations, all of which can compromise patient safety.
Has the dental profession seen real-world consequences from using compounded drugs?
We haven’t yet seen publicized dental-specific adverse events tied to compounded minocycline gels, but history provides sobering lessons. In 2012, the New England Compounding Center produced contaminated injections used for spinal pain management. More than 100 people died and more than 750 were infected. This occurred because the product bypassed FDA oversight, underscoring the dangers of unregulated compounded medications.
What about informed consent? What are dentists required to disclose?
Dentists are ethically, and, in many states, legally obligated to inform patients if they are going to receive a compounded drug, explain what "non-FDA approved" means, and outline the associated risks. Failure to provide this disclosure can violate informed consent standards and could be grounds for disciplinary action or legal claims.
What’s the malpractice risk for dentists?
If an adverse event occurs and it’s shown that the dentist used a compounded drug without properly informing the patient, malpractice insurers may deny coverage. That means the dentist could be personally liable for damages. Importantly, even if the patient is informed, coverage may still be denied in the event of an adverse outcome.
From a clinical standpoint, could using a less effective compound actually harm the patient?
Yes, it can. Inadequately treated periodontitis can progress, leading to bone loss, tooth loss, and potential systemic health consequences linked to chronic inflammation, such as cardiovascular disease and diabetes complications. Patients who believe they've received FDA-approved therapy but haven't are misled and left at greater risk.
How might this impact the profession’s reputation?
Patient trust is the foundation of dental care. If patients learn they were given a potentially less effective, unapproved product, especially if they were charged as if they received the FDA-approved treatment, it could erode confidence not only in that practice but in the profession as a whole.
Some might say compounding has legitimate uses. Is there ever a place for it in dentistry?
Absolutely. When no commercially available drug meets the patient’s needs or when there’s a true shortage, compounding can be appropriate. For example, if a patient has an allergy to an inactive ingredient in the approved version. But when an FDA-approved, clinically proven option like Arestin is readily available, replacing it with a compound is neither necessary nor advisable and, in some cases, illegal.
Do compounded versions save patients money?
Not always. In some cases, the patient is billed the same as they would be for an FDA-approved medication while the practice saves on acquisition cost. That means the cost benefit goes to the practice, not the patient. There’s both a potential clinical compromise and an ethical concern here.
If a dentist is currently using a compounded version, what's your advice?
Stop and reevaluate immediately. Consult your malpractice insurer, review informed consent obligations, and weigh the clinical risks. Periodontitis is a serious infection. The safest and most defensible approach is to use an FDA-approved treatment with proven safety, efficacy, and regulatory approval.
If you could send one message to the dental community about compounded minocycline gels, what would it be?
Patient safety must come first. If a drug hasn’t been FDA-approved, hasn’t been clinically proven, and isn’t necessary due to a shortage or a unique patient need, it’s not worth the risk to the patient, the provider, or the profession. This isn’t about rejecting innovation; rather, it’s about ensuring every treatment meets rigorous safety and efficacy standards. We owe it to our patients and ourselves to uphold the highest standards of care.
Disclosure: Dr. Donley is a paid consultant for OraPharma, a division of Bausch Health.
Dr. Tim Donley is an expert in the treatment of gum disease and dental implants. He is a sought-after international speaker, teaching dentists and hygienists around the world the state of the art in dentistry. He graduated from the University of Notre Dame and Georgetown University School of Dentistry. He completed his specialty residency at Indiana Medical Center in Indianapolis.
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