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ARESTIN safety and adverse events

The safety and efficacy of ARESTIN (minocycline HCl) Microspheres, 1 mg has been demonstrated as an adjunct to scaling and root planning (SRP) for the reduction of pocket depth in patients with adult periodontitis.1 

Adverse Events (AEs) reported in ≥3% of the combined clinical trial population of 3 multicenter US trials by treatment group1

Treatment-emergent AEs SRP alone 
N=250		 SRP + placebo 
N=249		 ARESTIN + SRP
N=423
Periodontitis 25.6% 28.1% 16.3%
Tooth Disorder 12.0% 13.7% 12.3%
Tooth Caries 9.2% 11.2% 9.9%
Dental Pain 8.8% 8.8% 9.9%
Gingivitis 7.2% 8.8% 9.2%
Headache 7.2% 11.6% 9.0%
Infection 8.0% 9.6% 7.6%
Stomatitis 8.4% 6.8% 6.4%
Mouth Ulceration 1.6% 3.2% 5.0%
Flu Syndrome 3.2% 6.4% 5.0%
Pharyngitis 3.2% 1.6% 4.3%
Pain 4.0% 1.2% 4.3%
Dyspepsia 2.0% 0% 4.0%
Infection Dental 4.0% 3.6% 3.8%
Mucus Membrane Disorder 2.4% 0.8% 3.3%

Feel confident knowing that in clinical studies, ARESTIN + SRP provided better results than SRP alone.1*

The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN compromises clinical attachment.1 

*Two single-blind, Phase III trials comparing ARESTIN + SRP to SRP alone and SRP + placebo (n=748). SRP was performed for all groups at baseline. ARESTIN or vehicle was administered to periodontal pockets ≥5 mm in the adjunctive therapy groups at baseline, 3 months, and 6 months. Efficacy was evaluated over 9 months.

REFERENCE: 1. ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg. Prescribing Information. OraPharma; Bridgewater, NJ.

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INDICATION

ARESTIN® (minocycline HCl) Microspheres, 1mg is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN® may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.

IMPORTANT SAFETY INFORMATION

  • ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines. Hypersensitivity reactions and hypersensitivity syndrome that included, but were not limited to anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis may be present. Swelling of the face, pruritus, fever and lymphadenopathy have been reported with the use of ARESTIN. Some of these reactions were serious. Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with oral minocycline, as well as acute photosensitivity reactions.
  • THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.
  • Tetracyclines, including oral minocycline, have been associated with development of autoimmune syndromes including a lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling. Sporadic cases of serum sickness-like reaction have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy and malaise. In symptomatic patients, diagnostic tests should be performed and ARESTIN treatment discontinued.
  • The use of ARESTIN in an acutely abscessed periodontal pocket or for use in the regeneration of alveolar bone has not been studied.
  • The safety and effectiveness of ARESTIN has not been established in immunocompromised patients or in those with coexistent oral candidiasis. Use with caution if there is a predisposition to oral candidiasis.
  • In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome, and pain.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information.

Click here for IMPORTANT SAFETY INFORMATION

  • ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines.
  • THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.