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Drugs Today – August 2008


FDA approves Cymbalta for fibromyalgia          
The Food and Drug Administration (FDA) has approved the antidepressant Cymbalta (duloxetine hydrochloride) for fibromyalgia management. The approval is based on data from two clinical trials in which the drug achieved more than a 30% reduction in pain compared to placebo. In both studies, about two-thirds of patients receiving Cymbalta reported feeling better since starting treatment.

Both conventional and atypical antipsychotics increase death risk in elderly dementia patients             
The FDA is now requiring manufacturers of conventional antipsychotics to add a boxed warning to the drugs’ prescribing information, similar to the one added in 2005 for atypical antipsychotics. The warning states that these drugs increase the risk of death in elderly patients with dementia-related psychosis. Physicians have used antipsychotics to reduce behavioral problems in dementia patients, but this use is no longer indicated.

Reanalysis: Finasteride reduces all prostate risks         
A recent study reanalyzed data on 16,000 men randomized to finasteride or placebo for 7 years. The Prostate Cancer Prevention Trial, originally published in 2003, found the drug reduced prostate cancer risk but increased the risk of high-grade cancers. However, reanalysis revealed the heightened risk stemmed from detection bias—and that finasteride reduced risk by some 30%. Journal commentators state that given the drug’s ability to decrease cancer incidence and its lack of toxicity, it should be offered to patients at risk for prostate cancer.

Once-daily Requip formulation approved           
The FDA has approved a new once-daily, extended-release formulation of Requip XL (ropinirole), a drug used to treat Parkinson’s disease. The new version promotes smoother blood levels without the highs and lows of multiple daily doses. In clinical trials, it improved symptoms in patients who weren’t controlled optimally with levodopa. The first and only oral once-daily nonergot dopamine agonist indicated for Parkinson’s disease, Requip allows a simple titration regimen.

Diabetic foot ulcer cream gets boxed warning           
A boxed warning has been added to the label of Regranex gel 0.01% (becaplermin) to address the increased risk of cancer deaths in patients who use three or more tubes. A recombinant platelet-derived growth factor, Regranex is used to treat poorly healing leg and foot ulcers in diabetes patients. A study compared cancer incidence and deaths among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients without exposure. Although the exposed patients showed no overall increase in cancer incidence, those who’d used three or more tubes had a fivefold increased risk of cancer death. The FDA cautions healthcare professionals that the drug isn’t recommended for patients with known cancer.

Once-yearly zoledronic acid approved to prevent fractures in high-risk patients         
Once-yearly zoledronic acid (Reclast) is now approved to prevent new fractures in patients with a history of hip fractures. The drug is an I.V. bisphosphonate used to treat osteoporosis. The label expansion comes after a randomized study in which older adults given the drug after hip-fracture repair were 35% less likely to experience new fractures than those given placebo. Adverse effects included fever and muscle pain, usually within 3 days of the infusion.

Fewer MIs but more deaths with perioperative beta blockers        
A new study questions the use of perioperative beta blockers before noncardiac surgery. In a large trial, patients were randomized to receive either metoprolol or placebo postoperatively for 30 days. All of them had a history of coronary disease, stroke, or peripheral vascular disease; recent hospitalization for heart failure; major vascular surgery; or any three of seven other criteria outlined in the protocol. The metoprolol group had fewer myocardial infarctions but more stroke and deaths than the placebo group. This finding contradicts several small trials from the late 1990s, which found perioperative beta-blocker use lowered the incidence of cardiac ischemic complications associated with noncardiac surgery.

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