Heidi Belden, PharmD

FDA approves a new molecular entity, Kuvan, to treat phenylketonuria.

Vaccines are not just for prevention, new ones are in development to treat diseases including malaria, HIV, and nicotine dependence.

New drugs in development for age-related macular degeneration (AMD).

The new guide recommends that physicians start with nonpharmacologic treatments such as exercise, physical therapy, weight loss, and heat or cold therapy. If there is no relief of pain, physicians should consider acetaminophen, aspirin, and even short-term use of narcotic analgesics as a first step, taking the patient's medical history into account.

For the 4.4 million American children who have attention deficit hyperactivity disorder (ADHD), there will soon be another option for treatment. The Food & Drug Administration recently approved the first prodrug to treat the condition: lisdexamfetamine dimesylate (Vyvanse).

A major change in the treatment of advanced or metastatic colon cancer has been made in a new update from the National Comprehensive Cancer Network (NCCN). The network's "Clinical Practice Guidelines in Oncology: Colon Cancer," published in January, were revised to reflect new scientific data and expert judgment.

Migraines are now viewed as a chronic disorder with episodic manifestations, and emphasis should be put on evaluating impairment between headache attacks. This is the gist of a new consensus statement recently released by the National Headache Foundation (NHF), an organization focusing on migraine prevention.

Now Type 2 diabetics will have another option for controlling blood glucose. Exenatide (Byetta, Amylin Pharmaceuticals) injection can now be used as add-on therapy in patients who have not achieved adequate blood glucose control on a thiazolidinedione (TZD). The drug was approved by the Food & Drug Administration for expanded combination use in December.

Pharmacists can now refer to a new treatment algorithm for the metabolic management of Type 2 diabetes when caring for patients. This is one new addition to the Standards of Medical Care in Diabetes-2007 from the American Diabetes Association (ADA). The clinical practice guidelines have been updated to include new information about treatment and prevention that reflects the latest research.

As many as one in five Americans, or 55 million people, suffer with the abdominal discomfort associated with irritable bowel syndrome (IBS), according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Symptoms vary from patient to patient but typically include abdominal pain and discomfort with changes in bowel function-either predominantly diarrhea (IBS-d) or constipation (IBS-c). Some patients, however, experience a mixed form (IBS-m), with alternating diarrhea and constipation. Currently there exist few therapies for treating the condition; however, several entities in development look promising.

The phone rings and it's the manager of the local supermarket. He asks whether you know a woman named Margaret. It's your mother. He informs you that she had been wandering the store aisles for more than two hours and then proceeded to get into her car and back into the side of the building. Although not injured, she seems disoriented, he says. On your way to her aid, you start thinking about all that hasn't been right with Mom for sometime. She's been so forgetful, her speech seems off, she repeats the same question multiple times, and she can't seem to find anything. You wonder if it could possibly be Alzheimer's disease.

In a unanimous vote, a Food & Drug Administration advisory group has recommended modifying antidepressant labels to include new information on the risk of suicidality in young adults.

No longer just for drinking, green tea is now part of an ointment used for the topical treatment of genital warts. The Food & Drug Administration recently approved the new therapy for both external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years of age and older. Called Veregen, the Rx botanical was developed by German company MediGene. It contains 15% kunecatechins, a defined green tea extract.

Our current system is not working and needs reform was the take-away message from a three-hour workshop examining both Medicare Part D and the future of drug pricing. Held at the American Public Health Association's 134th Annual Meeting, which convened in Boston in November, the workshop included speakers discussing the various issues surrounding the drug benefit and potential methods for reform.

Despite better tools, decreased time to Food & Drug Administration approval, and an unbelievable figure for 2006 projected pharmaceutical sales-$321.1 billion-the payoff for drug innovation in the United States has been lagging. Over the past 10 years, there has been an annual average of only 10 to 15 new molecular entities (NMEs) to receive a nod from the FDA through fast-track approval, and only five through the regular approval process. This was the news coming from the 2006 Annual Meeting of the American College of Clinical Pharmacy (ACCP), held in St. Louis in October.

Peak and trough serum levels should be measured for patients on vancomycin, right? Well, sort of. According to Sharon See, Pharm.D., BCPS, associate clinical professor at St. John's University College of Pharmacy in New York, only trough levels are necessary. And in most cases, no levels are needed at all. That was one medical myth that was exploded at the recent American College of Clinical Pharmacy (ACCP) annual meeting in St. Louis in October.

New molecular entities on the horizon for the treatment of osteoporosis face a tough row to hoe in their quest for approval from the Food & Drug Administration. That was the subject of a presentation at the 2006 Annual Meeting of the American College of Clinical Pharmacy (ACCP), held in October in St. Louis.

The Centers for Disease Control & Prevention (CDC) estimates that 1.25 million Americans are chronically infected with hepatitis B virus (HBV). Now a new, oral, once-daily treatment has been approved by the Food & Drug Administration and is indicated for the treatment of the illness in adult patients with both evidence of viral replication and either persistent elevations in serum aminotransferases or histologically active disease.

It's not a death sentence anymore, but drug resistance is a rising concern as research continues on a preventive vaccine

The long-awaited first dipeptidyl peptidase-4 (DPP-4) inhibitor will soon make its debut. Januvia (sitagliptin), from Merck & Co., has been approved by the Food & Drug Administration as both a monotherapy and an add-on treatment to improve glycemic control in Type 2 diabetes.

Advances in telehealth could enable senior citizens to remain living independently longer without the need for full-time care. That was one of the primary messages presented at Partners Telemedicine's Connected Health-Empowering Care Through Communication Technologies, a two-day symposium held recently at Harvard Medical School in Boston. An innovative role for the pharmacist was highlighted in one presentation as a key component to making this connection between technology and quality health care.

A diagnosis of metastatic colorectal cancer is not one that a patient wants to hear. It has historically been one of the most difficult cancers to treat, associated with mediocre responses and short survival periods. According to 2006 estimates from the American Cancer Society, colorectal cancer is now the second- and third-leading cause of cancer deaths in men and women, respectively, in the United States. Now a new treatment option is available for patients with metastatic cases that are refractory or intolerant to traditional agents. Enter panitumumab (Vectibix, Amgen).

The quivering and ineffective pumping of the heart during atrial fibrillation (AF) is associated with twice the mortality of persons with normal sinus rhythm. This statistic is one reason revised guidelines on how to treat the condition were recently released by the American College of Cardiology (ACC), the American Heart Association (AHA), and the European Society of Cardiology (ESC). "Guidelines for the Management of Patients with Atrial Fibrillation" was published in the Aug. 15 issue of Circulation. While the 2001 guide placed greater emphasis on using patient characteristics such as age, gender, and heart disease risk, the new guidelines highlight stroke risk as the primary means to determine the need for anticoagulants.

We know that about 400,000 people in the United States currently suffer from multiple sclerosis (MS), and it's more common in women and Caucasians. We also know that early treatment of the condition makes a difference. Recently, we've read that Biogen Idec and Elan Corp. were given the go-ahead to reintroduce natalizu-mab (Tysabri) for the treatment of relapsing forms of MS. But beyond that, we haven't heard too much lately regarding the treatment of this devastating disease. What, if anything, coming down the pipeline looks promising? Here are a few of the possibilities.

All symptomatic patients with HIV disease should begin antiretroviral therapy right away, according to new guidelines published by the International AIDS Society-USA and presented at the International AIDS Conference held in August in Toronto. Based on several new developments, the revision marks the seventh time since 1996 that the organization has updated its recommendations for HIV treatment.

Genetic testing and custom-tailored drug treatments promise a sea change in pharmacy practice

Managing patients with valvular heart conditions can be a real challenge. They often require lifelong monitoring, with replacement surgery and subsequent anticoagulation. Recently, in a joint effort, the American College of Cardiology (ACC) and the American Heart Association (AHA) revised their 1998 recommendations to create the ACC/ AHA 2006 Practice Guidelines for the Management of Patients with Valvular Heart Disease. The executive summary and recommendations were published in the Aug. 1, 2006, issues of the Journal of the American College of Cardiology and Circulation.