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FDA review: Anemia drugs, aprotinin on panel’s agenda

From the September ACP Observer, copyright © 2007 by the American College of Physicians.

By Jessica Berthold

Meeting outcomes

FDA reviewAn FDA panel voted July 30 that while diabetes drug rosiglitazone (Avandia) heightens heart attack risk, it should remain on the market. Later, the agency decided that the entire class of thiazolidine-diones for type 2 diabetes must be labeled to warn about heart risks. In another meeting, a panel recommended that Crohn’s disease patients be able to use natalizumab (Tysabri), first approved for multiple sclerosis. The drug was removed from the market in 2005 when three patients developed a brain infection, then was reinstated in 2006. In early August, a panel voted to ease restrictions on women’s access to isotretinoin (Accutane), an acne drug known to cause birth defects.

Upcoming meetings

Two FDA panels will meet jointly on Sept. 11-12 to offer recommendations. The Sept. 11 meeting will discuss the risks and benefits of using erythropoiesis-stimulating agents darbepoetin alfa (Aranesp), and epoetin alfa (Epogen, Procrit) to treat anemia in patients with chronic renal failure. Studies indicate the drugs may reduce survival and promote tumor progression in certain patients, especially when taken at higher-than-recommended doses. In March, the FDA added a black box warning to the drugs’ labels citing safety concerns and recommending use at the lowest dose possible.

The Sept. 12 meeting will discuss clinical data for aprotinin injection (Trasylol), which is meant to reduce perioperative blood loss and the need for transfusion in at-risk patients undergoing cardiopulmonary bypass during CABG surgery. Studies suggest an increased risk of death, kidney damage, congestive heart failure and stroke in patients treated with aprotinin injection. In December 2006, the FDA added a warning to the drug’s label about the risk of renal dysfunction.

Approvals

The GeneSearch BLN Assay, a molecular-based lab test to detect whether breast cancer has metastasized to nearby lymph nodes. Compared with microscopic examination of lymph nodes during surgery, the test gave fewer false negatives but slightly more false positives. A false positive can result in more extensive surgery and put women at risk of unnecessary lymphedema and other side effects.

Maraviroc (Selzentry), the first drug to block a pathway that HIV uses to infect cells, instead of targeting the virus directly. It is approved for adults with CC5-tropic HIV-1 who have been treated with other HIV medications but still have an elevated viral load. The label will warn of possible hepatoxicity and heart attacks.

Exelon Patch, the first daily skin patch to treat dementia associated with mild to moderate Alzheimer’s disease and Parkinson’s disease. The rivastigmine (Exelon) patch improved memory and the ability to perform everyday activities in a clinical trial.

The e100 NeuroRobotic System, a robotic arm brace for stroke survivors. The device has sensors that detect muscle contractions on the skin’s surface, then help the wearer control simple arm movements.

Pregabalin (Lyrica), the first drug approved to treat fibromyalgia. A study found some patients had less pain and improved daily functions at 300 mg or 450 mg per day. The most common side effects are mild to moderate dizziness and sleepiness.

The Binax NOW Malaria Test, the first rapid test for malaria. The blood test is faster and easier to use than standard laboratory tests, with results available within 15 minutes.

The first generic versions of terbinafine hydrochloride (Lamisil), for treating nail fungus infections (onychomycosis) with 250-mg tablets, and for treating athlete’s foot with over-the-counter cream.

The Prestige Cervical Disc for degenerative disc disease, which is attached to adjacent vertebrae with bone screws after a damaged disc is removed. A clinical trial found the replacement disc improved neck and/or arm pain, and was as safe and effective a treatment as cervical fusion.

Tegaserod maleate (Zelnorm) can now be used to treat irritable bowel syndrome with constipation and chronic idiopathic constipation in women younger than 55 under certain conditions. The drug was pulled in March when clinical trial data suggested a link to heart attacks, strokes and angina.

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