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The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

“This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

Folic acid is particularly important for pregnant women, and should be taken, if possible, beginning at least three months before they become pregnant.

The U.S. Centers for Disease Control and Prevention says this B vitamin can reduce the risk of major birth defects affecting the spine and brain by as much as 70 percent.

Women who are pregnant or planning to become pregnant should take 400 micrograms of folic acid daily. It can be contained within a multivitamin, or as a separate supplement.

Women also can get folic acid in fortified breakfast cereal. Just make sure the cereal has 100 percent of the recommended daily amount.

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.

Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

“The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

The five other drugs approved for kidney cancer and their approval dates are: Sorafenib (December 2005), Sunitinib (January 2006), Temsirolimus (May 2007), Everolimus (March 2009), and Bevacizumab (July 2009).

The safety and effectiveness of Votrient was evaluated in a 435-patient study that examined a patient’s progression-free survival – the length of time, following enrollment in the study, before the tumor began growing again or before the patient died. Progression-free survival averaged 9.2 months for patients receiving Votrient compared to 4.2 months for patients who did not receive the drug.

Adverse reactions included diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain and headache. Votrient can also cause severe and fatal liver toxicity. Health care professionals should order blood tests to monitor liver function before and during treatment with the drug. Since Votrient can harm a fetus, it should not be used during pregnancy.

The drug has also been associated with heart rhythm irregularities. Patients receiving Votrient should be monitored with periodic electrocardiograms, which measure heart rhythm, and blood tests to monitor electrolytes since an electrolyte imbalance can lead to an irregular heart rhythm.

New research suggests that patients need not fear post-operative nausea and vomiting as much if they take dextrose, a form of glucose.

“As one of the most common post-operative complications, [vomiting and nausea] remains one of the main causes of decreased patient satisfaction following surgery,” said Dr. Susan Dabu-Bondoc of Yale School of Medicine, one of the authors of a new study, in a statement. “Along with discomfort, the adverse effects can be extensive and may include aspiration, wound suture opening, prolonged hospital stays, unanticipated admission after outpatient surgery and delayed return of a patient’s ability to function in daily activities.”

The researchers, who were to release their findings Sunday at the annual meeting of the American Society of Anesthesiologists in New Orleans, report that they assigned half of 56 surgery patients to receive dextrose immediately after their operations. The other half got a placebo.

The patients were scheduled for gynecologic laparoscopic and hysteroscopic procedures. All patients were treated with general anesthesia and received a dose of a drug called an antiemetic, which can prevent some nausea and vomiting.

The researchers found that those who received the dextrose were at much lower risk of developing nausea and vomiting. They were also discharged from a post-operative care unit more quickly than the others.

“In light of the ease and low risk of administration of dextrose postoperatively and its apparent benefit to patient care and satisfaction, this therapeutic treatment should be considered in an attempt to prevent or reduce [vomiting and nausea] for patients in the immediate recovery period, ” said Dabu-Bondoc.

She called for more research to understand exactly how administering dextrose prevents nausea and vomiting.