Epocrates Drug Updates - Editor's Pick
July 24, 2015
Kybella Approved for Submental Fat
Kybella (deoxycholic acid) is the first injectable treatment available to improve the appearance of fullness associated with submental fat. The drug is indicated for the reduction of moderate to severe submental fat convexity and is administered as up to 50 SC injections per treatment. The safe and effective use of Kybella for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
July 24, 2015
FDA MedWatch Safety Alert for NSAIDs
The FDA is strengthening an existing warning that non-aspirin NSAIDs increase MI and stroke risk. MI and stroke risk may occur within the first weeks of NSAID treatment, and risk may increase with higher doses or longer treatment duration. Advise patients to use the lowest effective amount for the shortest effective treatment duration, and to seek immediate medical attention if cardiac signs or symptoms occur.
Noteworthy Recent Updates
July 13, 2015
FDA MedWatch Safety Alert for Codeine in Pediatric Patients
The FDA is investigating the safety of codeine-containing cough-and-cold products in pediatric patients due to risk of serious adverse effects, including respiratory depression. In April 2015, the European Medicines Agency (EMA) warned that codeine use for cough and cold is now contraindicated in patients.
July 6, 2015
Glatopa Available for Multiple Sclerosis
Glatopa (glatiramer) is the first branded generic available for Copaxone for the treatment of relapsing forms of multiple sclerosis. The drug is available in a 1-mL, 20-mg/mL injection for once-daily subcutaneous use. The 20-mg/mL dosage form is not additive or interchangeable with the Copaxone 40-mg/mL dosage form. Glatopa should not be used in patients with a hypersensitivity to glatiramer or mannitol.
June 29, 2015
Promacta Now Approved for Chronic ITP in Pediatric Patients
The FDA recently approved the use of Promacta (eltrombopag) in patients 6 years and older for the treatment of relapsed or refractory chronic ITP. Promacta is administered orally once daily at a starting dose of 50 mg, unless the patient is of East Asian descent, in which the starting dose is reduced to 25 mg. This is identical to the adult dosing regimen for the same indication. The dose of Promacta must be titrated according to the platelet count. Promacta should be taken on an empty stomach, and also needs to be separated from medications or supplements that contain polyvalent cations, such as calcium, magnesium, or aluminum.
June 29, 2015
FDA MedWatch Safety Alert for Daytrana (methylphenidate transdermal)
A permanent loss of skin color has been reported with an onset ranging from 2 months to 4 years after starting treatment. These areas of depigmentation occurred primarily at the patch application sites, though in a few patients, a loss of skin color was also reported at body sites where the patch was not applied. Prescribers should consider alternative therapy for patients who experience any skin color changes.
May 22, 2015
FDA MedWatch Safety Alert: Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors
The FDA recently warned that the type 2 diabetes medications canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis and result in hospitalization. In postmarketing reports, there was a temporal association between initiation of an SGLT2 inhibitor and diabetic ketoacidosis, ketoacidosis, or ketosis. The median time between starting an SGLT2 inhibitor and onset of ketoacidosis was 2 weeks. The FDA is investigating this safety issue and advises providers to evaluate for the presence of ketoacidosis in patients experiencing any signs or symptoms. If ketoacidosis is confirmed, discontinue the SGLT2 inhibitor, correct the acidosis, and monitor glucose levels.
New Drug Monographs
- alosetron (generic for Lotronex)
- Aptensio XR (methylphenidate)
- aripiprazole (generic for Abilify)
- bimatoprost ophthalmic (generic for Lumigan)
- Corlanor (ivabradine)
- Excedrin PM Headache (acetaminophen/aspirin/ diphenhydramine)
- Glatopa (glatiramer)
- Invega Trinza (paliperidone palmitate)
- Ixinity (coagulation factor IX (recombinant))
- Junel Fe 24 (norethindrone/ethinyl estradiol)
- Kybella (deoxycholic acid)
- levoleucovorin (generic for Fusilev)
- Lomedia 24 Fe (norethindrone/ethinyl estradiol)
- naftifine topical (generic for Naftin)
- Namzaric (memantine/donepezil)
- norethindrone acetate/ethinyl estradiol (generic for Femhrt)
- Prestalia (perindopril arginine/amlodipine)
- ProAir RespiClick (albuterol inhaled)
- Stiolto Respimat (tiotropium/olodaterol inhaled)
- Tivorbex (indomethacin)
- tolcapone (generic for Tasmar)
- Unituxin (dinutuximab)
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