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Drugs Today – September 2008

Warnings on fluoroquinolones          
The Food and Drug Administration (FDA) wants fluoroquinolones to come with a boxed warning about the increased risk of tendinitis and tendon rupture. The FDA also wants the makers of fluoroquinolones to provide patients with a medication guide about possible adverse effects.
Fluoroquinolones are approved to treat or prevent certain bacterial infections. The drugs affected by the FDA’s decision are ciprofloxacin (Cipro, Cipro XR, and Proquin XR), gemifloxacin (Factive), levofloxa­cin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin).

Methotrexate + etanercept         
The combination of methotrexate (Trexall, Rheumatrex) and etanercept (Enbrel), the anti–tumor-necrosis-factor drug, provides more relief from moderate to severe rheumatoid arthritis (RA) than methotrexate alone. In an industry-sponsored study, more than 500 patients with early RA received either the combination therapy or methotrexate alone for 1 year. Half of the patients receiving the combination therapy experienced clinical remission compared with only a quarter of the patients receiving methotrexate alone. The main adverse effects in both groups were nausea and naso­pharyngitis.

Homemade med errors     
According to a study of nearly 50 million U.S. death certificates, the number of people who died from medication errors at home rose sevenfold between 1983 and 2004. The deadly errors include overdosing and mixing prescription drugs with alcohol or street drugs. By contrast, the increase in fatal medication errors away from home and not involving alcohol or street drugs was only 5%.

ADHD therapy for adults          
Once-daily Concerta (methyl­phenidate) has been approved by the FDA to treat attention deficit hyperactivity disorder (ADHD) in adults up to age 65. Previously, it was approved only for children ages 6 to 18.
In clinical trials, the drug was “generally well tolerated,” according to the manufacturer. The most common adverse effects were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, and excessive sweating.

Acid-suppressing drugs and GI bleeds     
Patients who take selective serotonin reuptake inhibitors (SSRIs) or selective serotonin and norepinephrine reuptake inhibitors (SNRIs) appear to have a higher risk of bleeding in the upper GI tract. But according to a retrospective study, acid-suppressing drugs may reduce the risk.
Researchers found that upper GI tract bleeding was 1.6 times more likely in patients using SSRIs than in those who didn’t. Patients taking SNRIs were 2.9 times more likely to experience such bleeding. The researchers also discovered that taking acid-suppressing drugs appears to decrease the possibility of upper GI tract bleeding from SSRIs and SNRIs.

Restrictions for erythropoiesis-stimulating agents       
The FDA has told the manufacturer of epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp) to add safety-related information to the drug labels. The new labels must warn that the erythropoiesis-stimulating agents (ESAs) aren’t indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure. Also, the labels must state that ESA therapy shouldn’t be started if a patient’s hemo­globin level is 10 g/dL or higher and that doses should be withheld if a patient’s hemoglobin level is higher than needed to avoid transfusion.

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