New drug interactions have been added to the package inserts (product labeling) for Norvir (ritonavir) and Kaletra (lopinavir/ritonavir). Both drugs increase blood levels of fluticasone propionate (a synthetic corticosteroid, the active component of Flonase nasal Spray) and trazodone (Desyrel, a non-tricyclic antidepressant). In addition, alfuzosin (an alpha-blocker used to increase the flow of urine in people with benign prostatic hypertrophy, or BPH), was added to the contraindications [do not take together] for Norvir.

The U.S. Food and Drug Administration (FDA) reported that, “A drug interaction study in healthy subjects has shown that ritonavir significantly increases plasma fluticasone exposures, resulting in significantly decreased serum cortisol concentrations. Systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression have been reported during postmarketing use in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate. Therefore, coadministration of fluticasone propionate and Norvir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.

“Concomitant use of trazodone and Norvir increases plasma concentrations of trazodone. Adverse events of nausea, dizziness, hypotension and syncope have been observed following coadministration of trazodone and Norvir. If trazodone is used with a CYP3A4 inhibitor such as ritonavir, the combination should be used with caution and a lower dose of trazodone should be considered.”

The same comments hold true for Kaletra. For more information, visit, http://www.fda.gov/oashi/aids/listserve/archive.html.

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The pregnancy category for Sustiva has been changed from Category C (Risk of Fetal Harm Cannot Be Ruled Out) to Category D (Positive Evidence of Fetal Risk). According to a physician letter from manufacturer Bristol-Myers Squibb, “This change is a result of four retrospective reports of neural tube defects in infants born to women with first trimester exposure to Sustiva, including three cases of meningomyelocele and one Dandy Walker Syndrome. As Sustiva may cause fetal harm when administered during the first trimester to a pregnant woman, pregnancy should be avoided in women receiving Sustiva.

“Limited data are available regarding birth defects occurring after intrauterine exposure to Sustiva. The outcomes of pregnancy have been reviewed for 206 women (207 fetuses) after being exposed to efavirenz-containing regimens, most of which were first-trimester exposures. Birth defects occurred in 5 of 188 live births with first-trimester exposure and in 0 of 13 live births with second- or third-trimester exposure. None of these prospectively reported defects were neural tube defects. However, there have been 4 retrospective reports (i.e., after the results of the pregnancy were known) of findings consistent with neural tube defects, including 3 cases of meningomyelocele. All 4 mothers were exposed to efavirenz-containing regimens in the first trimester. Although a causal relationship of these events to the use of Sustiva has not been established, similar defects have been observed in preclinical studies of efavirenz.”