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Weekly News Round Up - February 29, 2012

Haloperidol Associated With Increased Risk of Death in Nursing Home Elderly

Haloperidol has a two-fold risk of death compared to risperidone use in elderly nursing home residents Read More...

Black Box Warnings for an increased risk of death when used in the elderly dementia patient exist on both atypical and conventional antipsychotics. However, despite warnings, these drugs continue to be highly utilized in nursing home patients. In a six month study published this week in the British Medical Journal, Harvard researchers studied antipsychotic use in over 75,000 nursing home elderly. The risk of death was measured for common antipsychotics - aripiprazole, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone. Haloperidol (Haldol) doubled the risk of death compared to risperidone use, while quetiapine (Seroquel) had a lower risk of death. The risk of mortality with haloperidol was highest in the first 40 days.

FDA Advisory Experts Recommend Approval of Qnexa

In a 20-2 vote, advisory panel endorses weight loss drug Qnexa; concerns over elevated heart rate, teratogenicity addressed Read More...

More than 78 million Americans suffer from obesity, a dangerous health risk factor. A U.S. Food and Drug Administration (FDA) advisory panel has recommended that Qnexa be approved as a treatment for obesity, along with diet and lifestyle changes. Previously, the committee voted against approval due to safety concerns such as increased heart rate and teratogenic effects in pregnancy. Vivus Inc., the sponsor of Qnexa (phentermine and topiramate), addressed those safety concerns last week with an action plan that may include a Risk Evaluation and Mitigation Strategy (REMS) program and restricted distribution. Vivus has also agreed to complete a large, prospective, post-approval clinical trial to assess cardiovascular risks in an at-risk, obese population. The FDA action date is April 17 for final determination of Qnexa’s fate.

CDC: All U.S. Adults Should Get Whooping Cough Vaccine

All adults aged 19 years and older who have not received pertussis vaccine should get it; growing outbreak in the U.S. Read More...

In 2010 over 21,000 people in the U.S. contracted whooping cough, also known medically as pertussis. The whooping cough is a bacterial infection that is can be deadly in infants. Adults can pass the disease on to infants, especially infants less than two months of age who have not yet had immunization. The U.S. Centers for Disease Control and Prevention (CDC) now recommends all adults over age 19 get the pertussis vaccine. Whooping cough originates from an easily spread bacteria and results in a violent cough and “whooping” sound when a breath is taken. The pertussis vaccine is readily available for older children and adults as a component of the tetanus and diphtheria toxoids with acellular pertussis (Tdap) booster vaccine.

FDA: Labeling Update For Statin Class of Cholesterol-Lowering Agents

Safety changes for cholesterol-lowering statins include less liver enzyme monitoring, warnings for increased blood sugar levels Read More...

The FDA has approved new safety information for the “statin” class of cholesterol-lowering drugs. Statins are used by millions in the U.S. and include blockbusters such as Lipitor (atorvastatin), Crestor (rosuvastatin), Mevacor (lovastatin) and Zocor (simvastatin). Routine monitoring of liver enzymes are no longer required; instead, liver tests only need to be performed prior to initial treatment and then as clinically indicated. The potential for transient memory lapses or confusion and an increased risk for elevated blood sugar and type 2 diabetes have been added to the class label. Multiple drug contraindications and dose limits specifically for lovastatin have also been updated to help avoid serious muscle injuries due to drug interactions.

Reversed Order of Birth Control Pills Prompts Second Recall This Month

Norgestimate/Ethinyl Estradiol recalled by Glenmark Generics; blisters rotated 180 degrees reversing weekly tablet orientation Read More...

Seven lots of Norgestimate/Ethinyl Estradiol Tablets (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25/0.035 mg) by Glenmark Generics, which is a generic version of Ortho-Tri-Cyclen, have been recalled. The packs have blisters that may be rotated 180 degrees reversing weekly tablet orientation. The lot numbers of recalled packages are: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. Women exposed to the recalled pills should begin using a non-hormonal form of contraception immediately, determine if they are pregnant, notify their physician and return any unused product to the pharmacy. This marks the second recent birth control pill recall, as in early February Pfizer recalled over one million birth control packs due to an error in pill count or sequence.

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