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Drugs Today – November 2008


Inhaled anticholinergics pose cardiovascular risk           
Patients using inhaled anticholinergics, ipratropium or tiotropium bromide, to treat chronic obstructive pulmonary disease (COPD) face an increased risk of cardiovascular events, according to a meta-analysis in the Journal of the American Medical Association.
The analysis included 17 trials and nearly 15,000 COPD patients using either an inhaled anticholinergic or a control therapy. Researchers found a significantly higher risk of myocardial infarction, stroke, and cardiovascular death in those using anticholinergics in long-term studies than in those in the control groups and those using anticholinergics in short-term studies. The researchers concluded that COPD patients using long-term anticholinergic therapy should be monitored for cardiovascular events.

Online reports on drug safety
Recently, the Food and Drug Administration (FDA) posted its first quarterly report listing drugs under evaluation for safety issues. Each drug is listed along with its potential risk. The operative word is potential. A listing doesn’t mean the FDA has determined that a drug causes the listed risk—only that the FDA has sufficient reason to evaluate the drug more closely.
This first quarterly report posted to the FDA’s website lists 20 drugs. Subsequent quarterly reports will not be cumulative. They will list only drugs for which new safety information or signals of serious risks have been identified during the previous quarter.     

Revlimid: Link to severe skin reactions?     
The FDA is warning that Revlimid (lenalidomide) may cause Stevens-Johnson syndrome and toxic epidermal necrolysis, a potentially fatal disorder. The drug was approved for the treatment of multiple myeloma in 2005. The possible link to the severe skin disorders came to light during the postmarketing safety review of the drug.

TNF-alpha blockers: Warnings must be stronger   
The manufacturers of Humira (adalimumab), Cimzia (certolizumab), Enbrel (etanercept), and Remicade (infliximab) must strengthen their warnings on the risk of developing opportunistic fungal infections, says the FDA. The beefed-up warnings will appear in the prescribing information and Medication Guides.
The four drugs, classified as tumor necrosis factor (TNF)-alpha blockers, are approved to treat such conditions as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease. Since the approval of the four drugs, the prescribing information has had information about the risk of serious infections, including fungal infections. But the FDA has determined that healthcare professionals aren’t consistently recognizing histoplasmosis and other invasive fungal infections, leading to delays in treatment.

Atypical antipsychotics better than first-generation antipsychotics?    
Atypical antipsychotics, such as olanzapine (Zyprexa) and risperidone (Risperdal), appear no more effective than first-generation antipsychotics such as molindone (Moban), according to an American Journal of Psychiatry study. Currently, atypical antipsychotics are the standard treatment for children and adolescents with early-onset schizophrenia and schizoaffective disorder. However, in an 8-week double-blind study of almost 120 patients, researchers found no significant difference in patient response to the two types of drugs.
They did find a difference in adverse reactions, though. Patients taking olanzapine gained about 13 pounds, and those taking risperidone gained about 8 pounds. By contrast, patients taking molindone didn’t gain weight.

FDA panel recommends restricted use of Fablyn     
Studies of Fablyn (lasofoxifene) indicate that it effectively treats osteoporosis in postmenopausal women, but it may also increase the risks of blood clots and gynecologic issues. According to an FDA advisory panel, these risks outweigh the drug’s benefits, and Fablyn should be used only in postmenopausal women at high risk for fractures and those who have tried other treatments without success. The FDA may accept or reject the advisory panel’s recommendation.

Betaferon: Early use may delay multiple sclerosis               
Because multiple sclerosis (MS) is difficult to diagnose, clinicians typically don’t begin therapy until after the second attack of symptoms. But a recent study of 468 patients suggests that treatment should begin sooner. Researchers found that treating patients with Betaferon (interferon beta-1b) after the first attack of symptoms delays the onset of MS by as much as 37% over 5 years. Plus, patients receiving early treatment have less severe disabilities and cognitive impairment as the disease progresses.

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