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warnings
WARNINGS THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY BROWN). This adverse reaction is more common during long-term use of the drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, OR IN PREGNANT OR NURSING WOMEN, UNLESS THE POTENTIAL BENEFITS ARE CONSIDERED TO OUTWEIGH THE POTENTIAL RISKS. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracyclines are used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
ADVERSE REACTIONS The most frequently reported non-dental, treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain. Table 5: Adverse Events (AEs) Reported in ≥3% of the Combined Clinical Trial Population of 3 Multicenter US Trials by Treatment Group SRP Alone N=250 SRP + Vehicle N=249 SRP + ARESTIN ® N=423 Number (%) of Subjects Treatment-emergent AEs 62.4% 71.9% 68.1% Total Number of AEs 543 589 987 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% Mucous Membrane Disorder 2.4% 0.8% 3.3% The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN compromise clinical attachment. Postmarketing Experience The following adverse reaction has been identified during postapproval use of minocycline products when taken orally. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders: Acute febrile neutrophilic dermatosis (Sweet’s syndrome). To report SUSPECTED ADVERSE REACTIONS, contact OraPharma at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.