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Weekly Drug News Round-Up: June 8, 2016

FDA Approves Allergan’s Byvalson for Hypertension

Byvalson is the first fixed-dose combo of a beta blocker and angiotensin II receptor blocker in the US Read More...

The FDA has approved Allergan’s Byvalson (nebivolol and valsartan), a beta adrenergic blocker and angiotensin II receptor blocker (ARB) fixed dose combination indicated for the treatment of hypertension (high blood pressure). In pivotal studies published in The Lancet with 4,100 randomized patients with Stage 1 or 2 hypertension, treatment with the fixed-dose combo of nebivolol and valsartan for 4 weeks led to statistically significant reductions in blood pressure versus either nebivolol alone or valsartan alone. Byvalson will be available in 5 mg/80 mg tablets and Allergan expects it to be available in the second half of 2016.

FDA: OTC Antacids Containing Aspirin Can Boost Bleeding Risk

Next time you have heartburn think twice before picking up a product from the pharmacy aisle Read More

The FDA is warning consumers that over-the-counter (OTC) aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach can lead to a serious risk of bleeding. Common names of such products include Alka-Seltzer original, Medique Medi Seltzer, and others, including generics. Those at great risk of bleeding, including stomach bleeding may be patients over 60 years of age, those with a history of stomach ulcers/bleeding, taking a blood thinner or steroid, taking NSAIDs, and/or consuming 3 or more alcoholic drinks per day. Many other products for these conditions are available that do not contain aspirin; ask your pharmacist for help in selecting one.

FDA Investigates Burns With Use of Zecuity Migraine Patch

Descriptions of burns include severe redness, pain, skin discoloration, blistering, and cracked skin Read More...

Zecuity (sumatriptan iontophoretic transdermal system) is used to treat migraine headaches and delivers sumatriptan via a battery-powered patch that is wrapped around the upper arm or thigh. However, FDA has received reports of serious burns and potential permanent scarring with the use of Zecuity. Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact their health care provider. Do not bathe, shower, or swim while wearing the patch. Zecuity should remain in place for no longer than four hours.

FDA: Serious Heart Risks Linked With Imodium

Most reports stemmed from high-dose misuse and abuse of loperamide Read More...

The FDA is warning that taking higher than recommended doses of the over-the-counter (OTC) and prescription antidiarrheal product loperamide (Imodium or Imodium AD), including abuse of the medicine, can lead to serious heart problems that can result in death. In addition, certain drug interactions with high-dose loperamide may result in serious heart problems such as abnormal heart rhythms. Health care providers should consider loperamide as a possible cause of serious heart conditions. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. Consumers should stop taking loperamide and call their doctor if diarrhea last for more than 2 days.

Longer Use of Aromatase Inhibitors Beneficial Without Lowering Quality of Life

Tamoxifen can be associated with more bothersome side effects Read More...

Aromatase inhibitors include drugs such as letrozole (Femara), anastrozole (Arimidex) and exemestane (Aromasin). These drugs are often used to lower breast cancer recurrence for women treated for hormone-receptor positive breast cancer. A new Harvard study presented at the American Society for Clinical Oncology (ASCO) meeting evaluated 1,900 postmenopausal women who had already received 5 years of Femara. Some of the women continued receiving Femara for another five years, while others received a placebo. Those who received Femara for the five additional years had a 34 percent lower risk of breast cancer recurrence than those who took the placebo. Quality of life and menopausal symptoms were similar between groups, too.