News & Trends

DECEMBER 07, 2011

FDA Reports Landmark Year For Drug Approvals

The FDA has approved 35 new drugs in the last 12 months, the secondhighest annual number in the past decade, according to a new report. Several of the approvals mark significant advances, including 2 new treatments for hepatitis C, a drug for late-stage prostate cancer, the first new drug for Hodgkin’s lymphoma in 30 years, and the first new drug for lupus in 50 years.

“We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century,” said Margaret Hamburg, MD, commissioner of food and drugs.

Other advances in terms of drug approvals from fiscal year 2011 include:

• 2 of the drugs—1 for melanoma and 1 for lung cancer—represent breakthroughs in personalized medicine

• 7 of the new medicines provide major advances in cancer treatment

• Almost half of the drugs were deemed to be significant therapeutic advances over existing therapies for heart attack, stroke, and kidney transplant rejection

• 10 are indicated for orphan diseases, which frequently lack any therapy

• 16 were approved under priority review, in which the FDA has a 6-month goal to complete its review for safety and effectiveness

• Two-thirds of the new approvals were completed in a single review cycle

• 3 were approved using “accelerated approval,” including Corifact, the first treatment approved for a rare blood clotting disorder. PT


Antidepressant Use Skyrocketing, Says Study

More than 10% of Americans 12 years and older are taking an antidepressant, according to a review by the Centers for Disease Control and Prevention’s National Center for Health Statistics, which also found that less than one-third of those using antidepressants have seen a mental health professional during the past year.

Analysis of data on more than 12,000 individuals participating in National Health and Nutrition Examination Surveys between 2005 and 2008 found that antidepressant use in the United States jumped nearly 400% during the survey period when compared with the 1988 to 1994 study period.

According to the survey, antidepressants were the third-most common drug used by Americans of all ages between 2005 and 2008, and the most common drug among individuals aged 18 to 44 years. In the United States, it was found that women are more than twice as likely to take antidepressants, and Caucasians are more likely than African Americans to take the drugs.

The survey also found that antidepressant use tends to continue over a long period of time. More than 60% of Americans who use the drugs report being on them for 2 years or more, and about 14% of Americans have taken antidepressant medications for 10 years or longer.

Although first introduced for depression, several antidepressants are now used to treat other issues, including anxiety disorders, obsessive compulsive disorder, bulimia, and posttraumatic stress disorder.


Switching From IV to Pill Form of Drugs Could Save Millions

For hospitalized patients who are able to take drugs by mouth, switching from intravenous (IV) medications to pill forms of the same drugs could result in substantially lower costs.

In a study published in the October 2011 issue of Clinical Therapeutics, researchers from Johns Hopkins Hospital found that swapping out 4 commonly prescribed IV medications— chlorothiazide, voriconazole, levetiracetam, and pantoprazole—for their oral equivalents led to an estimated savings of more than $1.1 million in the Department of Medicine alone. Using data from electronic records to examine medication use and compare costs, lead investigator Brandyn D. Lau and colleagues determined that in all 4 cases, use of oral medications resulted in significant savings. For example, the wholesale cost of a 5-mg tablet of chlorothiazide is $1.48, whereas an equivalent dose of the drug given intravenously is $357.24. Pantoprazole, a medication often given to patients several times per day, costs $4.09 per 40-mg tablet, whereas a 40-mg vial costs $144. The potential cost savings per patient for the acid reflux medication would be $680.98, the researchers found.

“Our study looked at just four drugs administered by one department in one hospital in one year and found more than a million dollars in potential savings,” said Lau. “Imagine if every hospital took a hard look at substituting oral medications for IV ones whenever possible. We’re talking about an enormous financial impact, with no risk to patients.”

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