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Weekly Drug News Round Up - June 26, 2013

Age Restrictions Dropped for OTC Plan B One Step Emergency Contraception

Plan B One-Step is a single 1.5 mg tablet that should be taken as soon as possible within three days after unprotected sex Read More...

The U.S. Food and Drug Administration has approved the use of nonprescription Plan B One Step as an emergency contraceptive regardless of the age of the woman. In addition, Plan B One Step will be sold over-the-counter (OTC) and stocked on pharmacy shelves. Plan B One-Step is an emergency contraceptive intended to reduce the chance of pregnancy following unprotected sex or a known or suspected contraceptive failure, such as with a condom. Previously Plan B One Step had only been available to women 15 years or older from behind the pharmacy counter. The date that Plan B One Step will be stocked on pharmacy shelves has not yet been released from Teva Women’s Health.

Americans Don’t Make the Grade for Proper Medication Use

The degree of personal connection with a pharmacist was a predictor of proper use of medications Read More...

The National Community Pharmacists Association has released a new report card survey for Americans who take medications -- and the results are poor. The report card was based on the findings of a national survey of more than 1,000 adults, aged 40 and older, who have received a prescription for a chronic medical condition. The results, which may be underreported because some people do not like to admit their nonadherence, noted that the participants earned a C+ in terms of taking their medication properly. One in seven -- the equivalent of more than 10 million adults -- were given an F.

Increased Mortality, Severe Renal Injury With Hydroxyethyl Starch Solutions

Excess bleeding also a risk in patients undergoing open heart surgery with cardiopulmonary bypass Read More...

The U.S. Food and Drug Administration (FDA) has concluded that hydroxyethyl starch (Hetastarch; HES) solutions should not be used in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and a Boxed Warning to include the risk of mortality and severe renal injury is warranted. HES solutions are used for the treatment of hypovolemia (low blood volume) when plasma volume expansion is desired. FDA has analyzed recent data that indicate an increased risk of mortality and renal injury requiring renal replacement therapy in critically ill adult patients, including patients with sepsis and those admitted to the ICU.

Mycamine Approved for Pediatric Candida Fungal Infections

Adult and pediatric studies, pediatric pharmacokinetic data demonstrate effectiveness and safety for new indications Read More...

Mycamine (micafungin sodium) for injection has been approved by the U.S. Food and Drug Administration (FDA) for treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, and for prophylaxis (prevention) of Candida infections in patients undergoing hematopoietic stem cell transplants. The overall safety of Mycamine was assessed in 479 patients, ages three days through 16 years, who received at least one dose of Mycamine in 11 separate clinical trials. Side effects in pediatric patients age four months and older included: vomiting (31%), diarrhea (22%), fever (22%), nausea (19%), stomach pain (16%) and low platelet levels (15%).

Vibativ Approved to Treat Staphylococcal Pneumonia

S. aureus pneumonia may present as a hospital-acquired lung infection in patients on ventilators Read More...

The antibiotic Vibativ (telavancin) has been approved by the U.S. Food and Drug Administration (FDA) to treat pneumonia caused by the bacteria Staphylococcus aureus when other treatments aren't suitable. Vibativ has been found to be as effective as vancomycin in treating S. aureus pneumonia. However, the studies found that more people treated with Vibativ died if they also had kidney problems, compared to patients with kidney dysfunction who took vancomycin. The FDA said it would add this information to Vibativ's label. Vibativ is also approved to treat skin and skin structure bacterial infections in adults.

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