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Weekly News Round Up - February 8, 2012

FDA: Proton Pump Inhibitors Linked with C. Difficile Diarrhea

Common stomach acid drugs associated with an increased risk for Clostridium difficile-associated diarrhea Read More...

Manufacturers will be updating product labeling for all Proton Pump Inhibitors (PPIs) such as Aciphex, Dexilant, Nexium, Omeprazole OTC, Prevacid, OTC Prevacid 24hr, Prilosec, Protonix, Vimovo, and Zegerid to reflect new data that PPIs may be associated with an elevated risk for Clostridium difficile-associated diarrhea (CDAD). CDAD is a type of diarrhea that may result in watery stools, abdominal pain and fever. PPIs are used for conditions such as gastroesophageal reflux disease (GERD), gastrointestinal ulcers, esophagitis, and heartburn. Patients who use PPIs and develop unresolved diarrhea should contact their health care provider. The U.S. Food and Drug Administration (FDA) is also investigating the possibility that histamine-2 blockers such as Pepcid or Zantac may be associated with CDAD.

Pfizer Recall: One Million Packs of Birth Control Pills

Packaging error leads to recall of 28 lots of oral contraceptives; errors in pill count, pill sequence possible Read More

Women who use either Lo/Ovral-28 or generic ethinyl estradiol/norgestrel contraceptives should check their birth control packets for recalled lot numbers. Pfizer has notified the U.S. Food and Drug Administration that some blister packs may contain an error in pill count of either inert or active tablets, and an error in pill sequence. Women who possess the recalled contraceptives, and have had pregnancy signs such as a missed period or abnormal bleeding, should be sure they are not pregnant by taking a pregnancy test. Women who are not pregnant should immediately switch to a non-hormonal form of birth control, inform their health care provider, and return the recalled package to the pharmacy.

NEJM: Morning-After Pill May Be Option For Uterine Fibroids

New research suggests morning-after pill may be effective for symptoms of uterine fibroids Read More...

Two studies published in the New England Journal of Medicine propose that the morning after pill ella (ulipristal) may be an effective option for women burdened with the pain and heavy menstrual bleeding that occurs in 25 percent of women with benign uterine fibroids. Current treatment options, which are not always ideal, include hormones such as Lupron (leuprolide) or oral contraceptives, sometimes combined with a hysterectomy. Women who took 5 or 10 milligrams of ella for 13 weeks had significantly less bleeding and smaller fibroids compared to the placebo group. When compared to Lupron injections, the women who used ella had a significantly lower incidence of hot flashes. Possible precancerous changes in the uterine lining, which reversed by 6 months after discontinuation, were noted in one study.

Jentadueto: Type 2 Diabetes Combination Drug FDA-Approved

Linagliptin and metformin are combined into one tablet for type 2 diabetes treatment Read More...

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Jentadueto (linagliptin/metformin), a twice-daily combination agent for glucose control in patients with type 2 diabetes. Jentadueto contains the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and the biguanide metformin. Both drugs are also available as separate treatments for type 2 diabetes - linagliptin as Tradjenta, and metformin as several brands or the more cost-effective generic. Studies demonstrated a placebo-corrected reduction in hemoglobin A1C of up to 1.7 percent. This week metformin was also recommended by the American College of Physicians as the preferred first-line oral drug treatment to be used in patients with type 2 diabetes in combination with lifestyle changes such as weight loss and exercise.

Sklice (ivermectin) Lotion 0.5% Approved for Head Lice

Single 10-minute application of Sklice effective for topical treatment of head lice in patients six months of age and over Read More...

While we don’t like to acknowledge it, head lice can happen. And school aged children are especially vulnerable, with an estimated 6 to 12 million children between three and eleven years having an infestation every year. A new topical head lice treatment, Sklice (ivermectin) Lotion 0.5%, has been approved that involves a one time, 10-minute application without the need for nit combing. The active ingredient in Sklice is ivermectin, also used as a prescription oral antiparasitic. In clinical trials, less than one percent of patients experienced side effects, which included conjunctivitis, eye redness and irritation, dandruff, dry skin and a skin burning sensation.

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