Cardiovascular

Drugs Today – October 2008

Study finds one-third of women have pelvic floor disorders    
One-third of American women have one or more pelvic floor disorders, according to a Kaiser Permanente study—and age doesn’t significantly contribute to the disorder. Using a validated questionnaire, the study assessed 4,000 women ages 25 to 84; 80% had given birth. Results showed that 25% suffered from anal incontinence, 15% from stress urinary incontinence, 13% from overactive bladder, and 6% from pelvic organ prolapse. Results should help dispel the myth that pelvic floor disorders affect only older women.
www.greenjournal.org/cgi/content/abstract/111/3/678

FDA approves first U.S. drug to treat Huntington’s disease       
The Food and Drug Administration (FDA) has approved the first drug to treat Huntington’s disease, a rare inherited condition that causes uncontrolled movements, mental deterioration and, ultimately, death. Xenazine (tetrabenazine) is designed to ease chorea—the jerky, involuntary movements seen in Huntington’s. It works by decreasing the amount of dopamine available at certain brain synapses. Safety and efficacy were established primarily in a randomized, double-blind, placebo-controlled multicenter trial. Patients receiving Xenazine it had a significant improvement in chorea compared to those treated with placebo. Potentially serious adverse effects include depression and suicidal ideation and behavior. The drug shouldn’t be used in patients who are suicidal or have untreated depression.
www.fda.gov/bbs/topics/NEWS/2008/NEW01874.html

Combining simvastatin with amiodarone raises rhabdomyolysis risk     
The FDA is warning that the risk of rhabdomyolysis, a rare muscle injury that can lead to renal failure and death, increases when patients take more than 20 mg of simvastatin daily in combination with amiodarone. All statins heighten the danger of rhabdomyolysis, but the risk rises when simvastatin is combined with amiodarone (presumably because amiodarone inhibits CYP3A4, an enzyme that metabolizes simvastatin more extensively than other statins). The FDA cautions physicians to avoid prescribing simvastatin dosages above 20 mg/day for patients taking amiodarone.
www.fda.gov/cder/drug/InfoSheets/HCP/simvastatin_amiodaroneHCP.htm

FDA updates pancreatitis warning for Byetta   
The FDA has alerted prescribers to six cases of hemorrhagic or necrotizing pancreatitis in patients taking exenatide (Byetta), an antidiabetic. In all six cases, patients required hospitalization; two died. The agency first warned prescribers last October of a possible link between the drug and acute pancreatitis; however, at that time, it hadn’t received reports of hemorrhagic or necrotizing pancreatitis. The FDA says patients with suspected pancreatitis shouldn’t receive exenatide, and the drug shouldn’t be restarted after treatment of confirmed pancreatitis. In confirmed pancreatitis, clinicians should start appropriate treatment and monitor the patient carefully until recovery. In patients with a history of pancreatitis, alternate antidiabetic therapies should be used.
www.fda.gov/CDER/Drug/InfoSheets/HCP/exenatide2008HCP.htm

First direct platelet-production stimulator approved for chronic ITP       
The FDA has approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce more platelets in patients with chronic immune thrombocytopenic purpura (ITP). In this disorder, the immune system destroys platelets, and the bone marrow may be unable to compensate for the loss. In two randomized trials involving 125 patients, those who received romiplostim over 6 months had significantly higher platelet counts than those not receiving the drug, and they maintained those higher counts. The drug is approved only for patients who don’t respond adequately to other treatments, such as corticosteroids and splenectomy. Adverse effects may include blood clots and fibrous deposits in the bone marrow. In addition, once the drug is stopped, platelet counts may drop below baseline. In patients with preexisting myelodysplasia, the drug may increase the risk of acute leukemia.
www.fda.gov/bbs/topics/NEWS/2008/NEW01876.html


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