The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to be approved in the US for this indication.

Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, in patients with RAS wild-type mutations, anti-EGFR therapy. The drug can be used in patients with mCRC regardless of biomarker status. Fruquintinib is the first drug to become available in the US for treatment of mCRC that targets 3 VEGF receptor kinases.

View the Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Diarrhea (IBS-D)

The erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp) are widely used for treatment of anemia and to reduce the need for red blood cell transfusions. Based on the results of recent clinical trials indicating an increased risk of serious adverse events and death associated with ESAs, particularly when used to achieve a hemoglobin concentration ≥12 g/dL, the FDA has revised the prescribing information for these drugs to include a black box warning.

Readers have inquired about the effectiveness and safety of operations on the cornea to correct refractive errors and restore normal vision without glasses or contact lenses. Several different operations are now being used for this purpose.

Sirolimus, whlch is structurally related to tacrolimus, has been approved by the FDA for prevention of acute renal transplant rejection. The manufacturer recommends that sirolimus be taken with cyclosporine and corticosteroids.

Bexarotene, a retinoid analog, has been approved by the US Food and Drug Administration for oral treatment of dermatologic manifestations of refractory cutaneous T-cell lymphoma.

Methamphetamine, a highly addictive synthetic sympathomimetic, has again become important as a drug of abuse in the US. Its resurgence has been associated with unsafe sexual practices that have resulted in an increase in HIV transmission, particularly among men who have sex with men (SJ Semple et al, J Subst Abuse Treat 2002; 22:149; A Urbina and K Jones, Clin Infect Dis 2004; 38:890).

Patients may be asking health care providers about the safety and effectiveness of Mucinex (Adams), which is being heavily advertised on television and elsewhere for treatment of respiratory congestion. These ads suggest that Mucinex is a new drug, when actually it is an extended-release formulation of guaifenesin, an old expectorant. Guaifenesin increases the volume of secretions in the respiratory tract, which facilitates removal of viscous mucus by coughing. Medical Letter consultants have not been impressed by its effectiveness. Guaifenesin is in the category of drugs - Generally...

(Med Lett Drugs Ther 2007; 49:55) The second sentence in the article ("The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.") should have been omitted. It would apply to a Class I device, but the FDA has classified Resperate as a Class II device.