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Weekly Drug News Round Up - May 8, 2013

FDA Approves New Cholesterol-Lowering Pill Liptruzet

Compared to atorvastatin, no incremental benefit of Liptruzet on lowering stroke or heart disease has been established Read More...

The U.S. Food and Drug Administration (FDA) has approved Liptruzet (ezetimibe and atorvastatin) tablets as an adjunct to diet for the treatment of elevated low-density lipoprotein (LDL) cholesterol in primary or mixed hyperlipidemia. Liptruzet contains ezetimibe, an LDL lowering therapy, and atorvastatin, one of the most common statins prescribed in the U.S. However, atorvastatin (Lipitor) became available as a generic product in 2011, and clinicians may question the effectiveness and higher cost of using Liptruzet without added benefit over atorvastatin alone. Additionally, Merck says Liptruzet will be sold at $5.50 per pill. Finally, some clinicians question the efficacy of ezetimibe to improve cardiovascular outcomes.

Sustiva Receives New Indication for Use in HIV-1 Infected Children

In clinical trials, rash was more common in pediatric patients (32 percent for all grades) and often more severe Read More...

Sustiva (efavirenz), has been approved by the U.S. Food and Drug Administration for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kilograms. This approval offers a once-daily option and includes a “capsule sprinkle” administration method for patients who cannot swallow capsules or tablets. Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was originally approved in the U.S. in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10 kilograms. In clinical trials of 182 pediatric patients, five (2.7 percent) discontinued the study because of rash.

Valproate Products Not to Be Used During Pregnancy for Migraines: FDA

Women who are pregnant and take a valproate drug should not stop their medication but should talk to their doctor immediately Read More...

The U.S. Food and Drug Administration (FDA) is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. There is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder. Drugs to avoid include: valproate sodium (Depacon), divalproex sodium (Depakote, Depakote Sprinkles and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

Generic Name Confusion: Kadcyla and Herceptin

Providers should use both the brand name Kadcyla and its generic name ado-trastuzumab emtansine for prescription orders Read More...

The U.S. Food and Drug Administration (FDA) notified providers that the use of the incorrect generic name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some electronic drug ordering systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. The FDA-approved generic name for Kadcyla, ado-trastuzumab emtansine, should be used. Some electronic systems are incorrectly using the United States Adopted Name (USAN), which is “trastuzumab emtansine,” and omitting the “ado” prefix and hyphen. Use of this shortened version of Kadcyla’s generic name may cause confusion with Herceptin (trastuzumab).

Drugs.com Releases Q1 2013 Sales for Top 100 U.S. Drugs

Rough U.S Flu Season Boosts Numbers for Tamiflu Read More...

Drugs.com, the leading online clinical drug resource, has released first quarter 2013 U.S. prescription sales data for the top 100 drugs. Abilify, Otsuka’s second generation antipsychotic, and Nexium, AstraZeneca’s leading acid blocker, rank as the top two drugs by sales for the fourth quarter in a row, with roughly $1.5 billion for quarterly sales. The most recent U.S. influenza season hit long and hard. Roche’s Tamiflu jumps 32 spots and posts a 65 percent sales increase. Incivek sales dropped — other Hepatitis C approvals are in the wings, and a serious skin reaction resulted in a newly penned Box Warning for Incivek.