Breakthrough Drugs

Each year, the FDA approves a variety of new prescription drugs. Most are "me too" drugs-that is, they are very similar to medications that are already available.

However: Some new drugs do represent significant breakthroughs. These medications treat diseases in entirely new ways or are the only available treatment for a given condition. Important new treatments of the past year…

Constipation

• Lubiprostone (Amitiza). It's one of the first prescription drugs, aside from laxatives, for treating chronic constipation in adults-specifically, idiopathic constipation, in which the cause is unknown.
  

Why it's important: Most patients with constipation can get significant relief with lifestyle changes, such as eating high-fiber foods, getting regular exercise, drinking more water, etc.

However, some patients don't always improve with these approaches

Taken orally, lubiprostone relieves constipation by increasing the secretion of intestinal fluids, which eases stool passage.

Side effects or complications: About 31% of patients taking lubiprostone have experienced nausea, while 13% reported headaches or diarrhea.

Dose: Take 24 micrograms (mcg) twice daily, with food. If side effects occur, the dosage can be reduced to once daily. Patients should ask their doctors how long they should take lubiprostone.

Cough

• Tdap (Adacel). Whooping cough, a highly contagious respiratory disease characterized by severe cough, has long been known to affect children, but this bacterial infection, also known as pertussis, strikes adults, too.
  

According to the Centers for Disease Control and Prevention (CDC), the number of people infected with pertussis has reached the highest level in 30 years. Nearly 26,000 cases were reported in the US in 2004, although the actual number may be as high as 600,000 cases annually among adults, according to the CDC. This is partly because only children—not adults—are routinely vaccinated against pertussis.

A new vaccine, called Tdap, provides protection against pertussis as well as tetanus and diphtheria--and it's approved for use by anyone ages ll to 64. Additional research is needed before it can be approved for people age 65 or older.

Why it's important: Adults infected with pertussis can transmit it to infants and children, who are at a high risk for complications, such as pneumonia, encephalitis (inflammation of the brain), seizures and even death. Older adults also can experience severe complications.

CDC advisory committee recommendation: If it's been 10 years since your last tetanus/diphtheria booster, ask for the Tdap vaccine the next time you see your doctor. Get it as soon as two years after your last booster if you spend time with children.

Side effects or complications: Fever and pain or swelling at the injection site.

Dose: The shot should provide protection for several years, but the exact duration is unknown.

Diabetes

• Insulin human (rDNA origin) inhalation powder (Exubera). Most people with diabetes who require insulin give themselves injections three or more times daily. The injections are inconvenient and sometimes uncomfortable.
  

Exubera is a dry, powdered form of insulin that is administered before each meal via a device similar to an asthma inhaler. It works as quickly as regular injected insulin and appears to be as effective in controlling blood sugar.

Why it's important: Inhaled insulin gives patients another treatment option to maintain optimal glucose control and it's easier to use than injections.

Side effects or complications: A mild to moderate cough. Some people have a temporary decrease in lung function in the first few weeks after starting treatment.

Important: Pulmonary testing is required before starting inhaled insulin. The tests are repeated at six months, then annually. If lung function declines by more than 20%, the drug should be discontinued and insulin injections resumed.

Caution: Inhaled insulin is not recommended for smokers, people with asthma, chronic obstructive pulmonary disease (COPD) or other lung diseases.

Dose: One or more inhalations taken before meals. The amount varies, depending on an individual's weight and needs.

Heart Disease

• Omega-3-acid ethyl esters (Omacor). Studies indicate that fish oil, from eating fish or taking supplements, can reduce the risk for cardiovascular death by up to 45%. Fish oil works, in part, by lowering triglycerides, blood fats that are harmful when elevated.

Omacor, a new prescription fish oil, has been found to reduce mortality in patients who have had a recent acute coronary event, such as a heart attack, by 29% after two years. At high doses, it can lower triglycerides by as much as 50%.

Why it's important: Fish oil supplements are sold over-the-counter OTC), so they aren't monitored by the FDA. Therefore, it's impossible to know if all fish oil products actually contain the amount of omega-3s (the beneficial oils in fish) listed on the label...or if the dose is standard in different products or even the same from pill to pill. As a prescription drug, Omacor is monitored by the FDA-and is tested to ensure that it meets quality standards.

Note: The US Pharmacopeia (USP), which sets official standards for supplements and drugs, has verified the content and purity of some OTC fish oil products. For a list of several fish oil supplements that have received USP certification, go to the USP Web site, www.usp.org

Side effects or complications: Like fish oil supplements, Omacor may cause belching and or a fishy aftertaste and can prolong bleeding time in patients taking high doses.

Important: If you take a blood-thinning drug, such as warfarin (Coumadin), consult your doctor before taking Omacor

Dose: 1 g daily for patients who have had a heart attack...and 2 g to 4 g daily for those with elevated triglycerides.

Smoking

• Varenicline (Chantix). It's a non-nicotine drug that appears to work better than other treatments at helping smokers quit.
  

Why it's important: Varenicline binds to nicotine receptors in the brain and reduces cravings. Studies indicate that it's more effective than nicotine patches or gums or bupropion (Zyban), which curbs cravings by altering the brain's chemistry in a way that is not precisely understood. In one 12-week study, the quit rate in smokers taking a placebo was 18%...30% in those taking bupropion...and 44% with varenicline.

Side effects or complications: Nausea or vomiting. It can't be taken by pregnant women because of a risk for birth defects.

Dose: 1 mg to 2 mg daily, divided into two doses.