Early in April, a House committee launched an inquiry into the marketing practices - particularly direct-to-consumer promotions - of the makers of several drugs prescribed to treat anemia. Then, late in May, the Federal Aviation Administration (FAA) banned the use of varenicline (Chantix) by pilots and air traffic controllers. Here's what you should know about recent concerns regarding both of these drugs.

Anemia drugs. Symptoms of anemia, such as fatigue, weakness, dizziness, and even shortness of breath, may be overcome either by raising blood red cell levels with blood transfusions or by administration of erythropoietin, a hormone that stimulates the bone marrow to make red blood cells. Three prescription drugs that boost production of erythropoietin - epoetin alpha (Epogen®, Procrit®) and darepoetin (Aranesp®) - are approved for treating the anemia associated with either chronic kidney disease or chemotherapy for certain types of cancers.

Because these drugs can often raise red cell levels, they thereby reduce the costs and risks of transfusions, as well as improve anemia symptoms in patients with kidney failure. However, there is no convincing evidence that they prolong survival or increase the quality of life of patients receiving cancer chemotherapy.

The Food and Drug Administration (FDA) now cites evidence indicating that patients with kidney failure face greater risks of death, heart attacks, strokes, and heart failure if these anti-anemia drugs are too effective and increase red cell levels (measured as hemoglobin) by too much. Likewise, raising hemoglobin levels too high in cancer patients also shortened their survival times and the time to progression of cancers.

The Congressional investigation was incited not only by these ill effects of the drugs but also because they are often used - and promoted by the drug companies - to treat cancer patients who are not undergoing chemotherapy, despite evidence that this patient population derives no benefit from these drugs.

Anti-smoking drug ban in the airline industry. The second drug warning prohibits pilots and air traffic controllers from using varenicline (Chantix). Chantix promotes smoking cessation by blocking the nicotine receptors in the brain responsible for the pleasurable sensations of smoking. The drug was approved in May 2006, but in February 2008 the FDA stated that Chantix is apparently responsible for serious psychiatric problems in its users, including behavioral changes, depressed mood, agitation, and suicidal ideation, accompanied by an increase in attempted and completed suicides.

In its ban of Chantix, the FAA cited a report by the Institute for Safe Medication Practices that detailed 173 serious accidental injuries, for example from road accidents and falls. Also described were 68 cases of blurred vision, 86 cases involving seizures, and 372 reports of movement disorders.

Two bottom lines you should consider:

• If you are taking erythropoietin drugs, you should be aware of the fact that they are not approved for all cancer patients. You should also check with your doctor to be sure that the drugs are stopped if they are not raising your hemoglobin and to learn if the drugs have worked so well that your hemoglobin has increased to dangerously high levels.
• If you are taking Chantix, you should promptly tell your doctor if you notice the onset of any of the psychiatric problems mentioned by the FDA.