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FDA actions

January 2, 2015

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FDA actions

A new FDA warning states that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. The LABAs salmeterol (Serevent®) and formoterol (Foradil®) have been associated with severe worsening of symptoms when used without a controller medication such as an inhaled corticosteroid. Both products will be required to include warnings on the product label that states:

  • Use of LABAs is contraindicated without the use of an asthma controller medication;
  • LABAs should only be used long term in patients whose asthma cannot be adequately controlled on asthma controller medications;
  • LABAs should be used for the shortest duration of time required to achieve control, and should be discontinued once asthma control is achieved;
  • Pediatric and adolescent patients who require an LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled steroid and a LABA to ensure compliance with both medications.

The FDA has approved rosuvastatin (Crestor®) for primary prevention in patients without elevated LDL-cholesterol but who have an elevated C-reactive protein (2 mg/L or higher) and at least one additional cardiovascular risk factors such as low HDL, hypertension, or family history of premature heart disease. The approval was based on the JUPITER trial, which showed a 44% reduced relative risk of cardiovascular events in patients with normal LDL cholesterol but elevated CRP.

The FDA has approved a new pneumococcal vaccine for infants and children. Wyeth Pharmaceuticals' Prevnar 13™ is a 13-valent conjugate vaccine that will replace the currently available 7-valent Prevnar®. It is approved for the prevention of invasive disease caused by 13 different serotypes of S. pneumoniae.

The FDA has approved the monoclonal antibody rituximab (Rituxan®) to treat certain patients with chronic lymphocytic leukemia (CLL). Rituximab is approved for CLL patients who are starting chemotherapy for the first time and also for those who have not responded to other CLL therapies. It is administered with fludarabine and cyclophosphamide for the treatment of CLL. Rituximab is manufactured by Genentech.

The FDA is initiating a risk-management program for erythropoiesis-stimulating agents (ESAs) for the treatment of chemotherapy-related anemia. The drugs, which include epoetin alfa (Procrit®, Epogen®) and darbepoetin alfa (Aranesp®), have been associated with accelerated tumor growth and higher mortality rates in some cancer patients. The Risk Evaluation and Medication Strategy (REMS) requires that patients receive a medication guide on safety issues associated with the drugs and requires training and certification of health care professionals who administer chemotherapy to patients with cancer and counseling of patient regarding the risks of the drugs. The REMS does not currently apply to patients being treated with an ESA for anemia due to other conditions, specifically renal failure.