Revisiting Drugs in 2011 (Part 1)

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1. Labeling changes to glitazones were made in 2011. Rosiglitazone and all rosiglitazone-containing products now include information regarding a possible increased risk for heart attacks.
2. Pioglitazone and all pioglitazone-containing medicines now include information regarding a possible increased risk for bladder cancer associated with use for more than 1 year.
3. The strength of prescription acetaminophen products was limited to 325 mg per dose. Prescription products containing acetaminophen are to include a black box warning with information about risk for severe liver injury with use and an addition to the warning section regarding risk for severe allergic reactions with use.
4. The FDA has also issued a warning to parents about potential confusion stemming from the recent introduction of a new 160 mg/5 mL strength of acetaminophen marketed for use in infants and young children.
5. FDA warning to healthcare professionals that prolonged use of prescription PPIs — usually longer than one year– may result in hypomagnesemia.
6. FDA reported that risk for fracture and osteoporosis is unlikely with OTC PPIs due to low-dose and short-term indications for use.
7. The FDA approved rivaroxaban, an oral factor Xa inhibitor, for prevention of deep venous thrombosis after knee or hip replacement surgery as well as to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
8. The FDA warned that simvastatin 80 mg (should not be used in new patients or in patients already taking lower doses due to risk for myopathy. The recommended dose for use with amiodarone was raised to 20 mg from the 10 mg originally recommended in June.
9. The FDA warned that fenofibric acid may not reduce risk for heart attack or stroke.
10. Linagliptin, a dipeptidyl peptidase-4 inhibitor, was approved on May 2 to improve blood glucose control in adults with type 2 diabetes.
11. The glucagon-like peptide-1 receptor agonist exenatide received expanded approval as an adjunct to insulin glargine, with or without metformin and/or thiazolidinedione therapy, in patients with type 2 diabetes not controlled on insulin glargine alone.
12. The FDA warned that an increased risk for high-grade prostate cancer is associated with use of 5-alpha reductase inhibitors (5-ARIs). These agents, including finasteride and dutasteride.
13. Previously licensed for patients between 10 and 64 years of age, Tdap (tetanus toxoid/reduced diphtheria/acellular pertussis) was approved on July 8 for adults 65 years and older.
14. On July 1, the FDA approved indacaterol inhalation powder (a once-daily, long-acting beta-2 adrenergic agonist (LABA) for treatment of COPD in adults.
15. On March 1, once-daily, oral roflumilast was approved to decrease the frequency of COPD exacerbations.
16. Roflumilast is the first in a new class of drugs for COPD called phosphodiesterase type 4 inhibitors.
17. The antiplatelet agent, ticagrelor was approved after a protracted process. The approval comes with a boxed warning stating that use of ticagrelor with aspirin doses above 100 mg/day decreases the effectiveness of the medication.
18. In December, the combination of azilsartan medoxomil and chlorthalidone was approved for the treatment of hypertension.
19. On July 22, the FDA reported labeling changes for varenicline with updated information on use in patients with stable cardiovascular disease and COPD, as well as alternative directions for use.
20. The FDA warned that long-term, high-dose fluconazole may be associated with birth defects.
21. A possible increased risk for cognitive delay in children born to mothers who have taken valproate sodium, valproic acid, or divalproex sodium was announced.