Rasagiline (Azilect - Teva), a monoamine oxidase-type B (MAO-B) inhibitor, was recently approved by the FDA for once-daily oral treatment of Parkinson's disease (PD). It can be taken alone for treatment of early disease or with levodopa/carbidopa (Sinemet, and others) for advanced disease. Selegiline (Eldepryl, and others), the first MAO-B inhibitor marketed in the US, has been available since 1988; a new lower-dose disintegrating tablet (Zelapar) was recently approved.

Standard approaches to therapy for gastroesophageal reflux disease (GERD) include lifestyle changes, over-the-counter and prescription drugs, and sometimes surgery. Emerging endoscopic anti-reflux procedures that are less invasive than surgery are potential additions to current treatment options. An endoscopicallyguided radiofrequency (RF) energy delivery system, Stretta (Curon Medical), was approved by the FDA for treatment of GERD in 2000.

Intravenous immunoglobulin (IVIG) has 6 FDA approved indications and is prescribed off-label for many others. How many of these uses are justified is controversial.

Nabilone, an oral synthetic cannabinoid similar to delta-9-tetrahydrocannabinol (THC), the active ingredient in marijuana, has recently been reintroduced to the US market (Cesamet - Valeant) after a 17-year absence. The previous manufacturer discontinued marketing of the drug for commercial reasons. Nabilone is classified as a Schedule II controlled substance.

Posaconazole (Noxafil - Schering-Plough), an oral azole antifungal with a chemical structure similar to that of itraconazole (Sporanox), has been approved by the FDA to prevent Candida and Aspergillus infections in severely immunocompromised patients and for treatment of oropharyngeal candidiasis. It is likely also to be used off-label for treatment of other fungal infections, including those caused by Mucor and other Zygomycetes.

The FDA has approved an extended-release formulation of minocycline (Solodyn - Medicis) for once-daily treatment of non-nodular moderate to severe acne.

The gram-positive anaerobic bacillus Clostridium difficile is the most common identifiable cause of antibiotic-associated diarrhea. The antibiotics most often implicated have been ampicillin, second and third generation cephalosporins, clindamycin and fluoroquinolones. The emergence in recent years of a new, more toxic epidemic strain (BI/NAP1), possibly related to widespread use of fluoroquinolones, has caused a marked increase in the incidence and severity of C. difficile-associated disease (CDAD).

Decitabine (Dacogen - MGI Pharma), a pyrimidine nucleoside analog of cytidine, was approved by the FDA as an orphan drug for treatment of myelodysplastic syndromes (MDS), a heterogeneous group of clonal hemopathies that decrease production of normal blood elements (red cells, white cells and platelets) and are associated with a risk of progression to acute leukemia.

The FDA has approved ranibizumab (Lucentis - Genentech) as an intravitreal injection for treatment of neovascular (wet) age-related macular degeneration (AMD). Ranibizumab is a derivative of bevacizumab (Avastin), which is FDA-approved for intravenous treatment of metastatic colorectal cancer and nonsmall cell lung cancer, but has also been used off label for intravitreal treatment of neovascular AMD.

Antiviral drugs can be used to control institutional influenza outbreaks and for prophylaxis of influenza exposures that occur before or less than 2 weeks after vaccination with inactivated vaccine, or in years when circulating strains differ from those included in the vaccine. They can also be used for early treatment of patients with influenza.

Since the publication of our article on influenza vaccine (October 9, 2006), a fourth inactivated vaccine (FluLaval - GlaxoSmithKline) has been approved by the FDA for use in people ≥18 years old. It is sold in 5-mL multi-dose vials. Each 0.5-mL intramuscular dose contains 25 mcg of mercury.

Annual immunization against influenza A and B is the most effective method of preventing infection and has been shown to reduce associated complications.

Implanon (Organon), an implantable contraceptive containing the progestin etonogestrel, has been approved by the FDA. Two other implantable contraceptives, Norplant and Jadelle, which both contain levonorgestrel, are FDA-approved but not marketed in the US.

Three new combination oral contraceptives (COCs) with shortened hormone-free intervals, Seasonique, Loestrin 24 Fe and Yaz, have recently been approved by the FDA. All 3 are derivatives of older products.

Atripla (Gilead/Bristol-Myers Squibb) is the first once daily, single-tablet combination of 3 antiretroviral drugs for treatment of HIV infection. Each tablet contains 600 mg of the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva), 200 mg of the nucleoside reverse transcriptase inhibitor (NRTI) emtricitabine (Emtriva), and 300 mg of the nucleotide reverse transcriptase inhibitor (NRTI) tenofovir DF (Viread). These drugs have been recommended for use together, if resistance testing confirms susceptibility, as an initial regimen of choice for treatment-na∩ve patients.

The US Advisory Committee on Immunization Practices (ACIP) has recommended the addition of a routine second dose of varicella vaccine for children <13 years old. Varicella vaccine has been used in the US since 1995, but varicella outbreaks have continued to occur among school children vaccinated with a single dose. In one such outbreak, the attack rate was 100% in unvaccinated children and 18% in those previously vaccinated.1 In vaccinated children, the typical maculopapular-vesicular rash of varicella may be only maculopapular with few or no vesicles, but these children could still transmit virus to susceptible contacts.

A live attenuated varicella-zoster vaccine (Zostavax - Merck) has been approved by the FDA for prevention of herpes zoster (HZ; zoster; shingles) in persons ≥60 years old. Each dose of Zostavax contains about 14 times as much varicella-zoster virus (VZV) as Varivax, which has been used in the US since 1995 to vaccinate against varicella (chicken pox).

Darunavir (Prezista - Tibotec), a new protease inhibitor, has received accelerated approval from the FDA for use in combination therapy of human-immunodeficiency virus (HIV) infection in previously treated adults. It is coadministered with low-dose ritonavir (Norvir), which increases its bioavailability.

Statins have been shown to reduce the risk of stroke in patients at high risk for cardiovascular disease (Treat Guidel Med Lett 2005; 3:15). A recent issue of The New England Journal of Medicine includes the results of a study sponsored by the manufacturer in which 80 mg of atorvastatin (Lipitor – Pfizer) or placebo was given to 4731 patients without coronary artery disease who had had a stroke or transient ischemic attack (TIA) within one to six months before study entry (The Stroke Prevention by Aggressive Reduction in Cholesterol Levels [SPARCL] Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006; 355:549). Patients were not required to have elevated cholesterol levels to enroll. The authors conclude that the study results support starting atorvastatin treatment soon after a stroke or TIA.

The primary study endpoint was a nonfatal or fatal stroke. During a median follow-up of 4.9 years, patients treated with atorvastatin had 265 strokes compared to 307 strokes with placebo. Patients treated with atorvastatin had 56 fewer ischemic strokes and 22 more hemorrhagic strokes. They also had 39 fewer coronary events. There were 216 deaths among patients treated with atorvastatin and 211 among those treated with placebo.

Whether patients with a recent ischemic stroke or TIA would be as well protected against a recurrence and against coronary events by a lower dose of atorvastatin or by another less potent statin remains to be determined. The risk of myopathy and rhabdomyolysis with statins is dose-related; atorvastatin is the second-most potent statin on the US market (rosuvastatin is the most potent), and 80 mg is its maximum dose. Statins have an antithrombotic effect, and an increase in hemorrhagic stroke in patients with cerebrovascular disease treated with statins has been reported previously (Heart Protection Collaborative Study, Lancet 2004; 363:757). It is doubtful whether patients with a recent hemorrhagic stroke should be treated with statins at all, let alone a maximum dose of atorvastatin.

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Soon after The Medical Letter first reviewed use of natalizumab (Tysabri – Biogen Idec and Elan) for treatment of relapsing forms of multiple sclerosis (MS) (Med Lett Drugs Ther 2005; 47:13), the drug was withdrawn from the market. The unpublished clinical trials that led to its approval by the FDA have since been published, and now the drug has been returned to the market with prescribing restrictions.

Natalizumab decreases the number of relapses and new brain lesions in patients with MS. It was withdrawn because progressive multifocal leukoencephalopathy (PML) occurred in 3 (of about 3000) patients being treated with the drug; two were taking the drug in combination with interferon beta for MS, and one was taking it with azathioprine for Crohn’s disease. PML is an opportunistic infection of the brain, caused by reactivation of the JC virus in immunosuppressed patients, that often causes death or severe neurological disability. There is no treatment for PML.

The publication of the natalizumab clinical trials in MS provided information on the drug’s effect on the progression of disability, which was not available when it was first reviewed here. In one study, combination therapy with natalizumab and interferon beta-1a for 2 years led to an estimated cumulative probability of progression of 23%, compared to 29% with interferon beta-1a alone (RA Rudick et al. N Engl J Med 2006; 354:911). In the second study, the estimated cumulative probability of progression over 2 years was 17% with natalizumab alone and 29% with placebo (CH Polman et al. N Engl J Med 2006; 354:899).

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The FDA has approved over-the-counter (OTC) sales of Plan B (Duramed), an emergency contraceptive package that contains two 0.75-mg tablets of levonorgestrel, to women ≥18 years old. Younger women still require a prescription. In one trial, two levonorgestrel 0.75-mg tablets taken 12 hours apart, the first within 72 hours after unprotected intercourse, decreased the pregnancy rate to 1%, compared to an expected rate of 8% (Task Force on Postovulatory Methods of Fertility Regulation, Lancet 1998; 352:428). How high doses of a progestin taken after coitus prevent pregnancy is unclear; they may interfere with ovulation, fertilization or implantation.

Nausea and vomiting can occur. The drug will not terminate an established pregnancy. No fetal malformations have been reported after unsuccessful use.

Plan B will not be available OTC until the end of the year, according to the manufacturer, and the OTC price is not yet available. The retail price for the prescription product varies from about $25 to $40. In order to enforce the age restriction, the drug will be kept behind the pharmacist’s counter, and a valid photo ID will be required.

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A recombinant quadrivalent human-papillomavirus-like particle vaccine, Gardasil (Merck), has been approved by the FDA for use in girls and women 9-26 years old to prevent diseases associated with infection with human papillomavirus (HPV) types 6, 11, 16, and 18, including genital warts, precancerous cervical, vaginal or vulvar lesions, and cervical cancer.

Varenicline tartrate (Chantix - Pfizer) is now available for oral treatment of tobacco dependence. Some other drugs for this indication are listed in this article.

Ibandronate (Boniva - Roche) is the first bisphosphonate approved by the FDA for intravenous (IV) treatment of osteoporosis in postmenopausal women. It is given as a bolus injection once every 3 months. Ibandronate is also available as an oral once-a-month 150-mg tablet and as a daily 2.5-mg tablet.

The US manufacturer of varicella zoster immune globulin (VZIG; Massachusetts Public Health Biologic Laboratories, Boston, MA) recently discontinued its production. A Canadian formulation, VariZIG (Varicella Zoster Immune Globulin [Human] - Cangene Corporation, Winnipeg) is now available in the US under an investigational new drug application expanded access protocol.

Sudden cardiac arrest has a survival rate of about 6% without immediate defibrillation. Automated external defibrillators (AEDs) can be found in many public locations such as shopping malls, office buildings and schools. Some patients may ask their physicians whether they should purchase an AED for personal use. One device has been FDA-approved for sale over the counter (HeartStart Home Defibrillator - Philips). Purchase of all other AEDs for public places or home use requires authorization from a physician.

The results of a randomized, placebo-controlled trial of calcium and vitamin D supplements in more than 36,000 postmenopausal women, conducted as part of the Women’s Health Initiative (RD Jackson et al. N Engl J Med 2006; 354:669), have been misinterpreted by some patients to mean that they should stop taking such supplements.

At the time of recruitment, the participants in this study had an average daily calcium intake of 1100-1200 mg. They were randomized to take either 1000 mg of calcium carbonate plus 400 IU of vitamin D₃ or a placebo for an average of 7 years. Both groups were permitted to take calcium and vitamin D supplements on their own as well. In the intention-to-treat population, the study supplements increased hip bone density but did not decrease the incidence of hip fractures. The subgroup of women who adhered to the protocol and actually took the study supplements showed a significant reduction in hip fractures compared to the control group.

Men and women over age 50 should have a total calcium intake of about 1200 mg per day (Treat Guidel Med Lett 2005; 3:69). If they need a supplement to achieve that, calcium citrate is more expensive, but it offers some advantages over calcium carbonate: it can be taken without food, causes less GI disturbance and may be less likely to cause kidney stones.

With any calcium salt, vitamin D is necessary for optimal absorption. The recommended minimum daily requirement of vitamin D (vitamin D₃ is preferred) is 400 IU for people 50-70 years old and 600 IU for those over 70. But those infrequently exposed to the sun may need 800- 1000 IU of vitamin D daily, and many experts recommend 800 IU or more for all postmenopausal women.

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The FDA has recently approved RotaTeq (Merck), an oral live, human-bovine reassortant rotavirus vaccine, for use in infants to prevent rotavirus gastroenteritis, a frequent cause of severe diarrhea in infancy.

An injectable extended-release formulation of the opioid-receptor antagonist naltrexone (Vivitrol - Alkermes/Cephalon) has been approved by the FDA for once-monthly use, along with psychosocial support, to maintain abstinence from alcohol. Naltrexone inhibits the rewarding effects of alcohol. Oral naltrexone (Revia, and others) has been approved for treatment of alcohol dependence since 1994, but poor adherence has limited its effectiveness. In the new extended-release (XR) formulation, naltrexone is encapsulated in polylactide-co-glycolide microspheres (similar to absorbable suture material) and placed in aqueous suspension for intramuscular (IM) injection.

An inhaled, dry-powder formulation of rapid-acting human insulin (Exubera - Pfizer) has been approved by the FDA for treatment of adults with type 1 or type 2 diabetes.

Omega-3 (n-3) polyunsaturated fatty acids (PUFAs), mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential human nutrients. The main dietary source of PUFAs is fatty fish such as salmon, but small amounts may be converted from α-linolenic acid in nuts, seeds, and plant oils such as canola or flaxseed oil. An increased intake of these fatty acids has been shown to modify membrane function, inhibit thrombus formation, decrease inflammation, lower plasma triglycerides, and alter the electrical activity of the myocardium.

When the use of aspirin for primary prevention of cardiovascular diseases was last reviewed in The Medical Letter, only one placebo-controlled prospective trial was available: the (male) Physicians' Health Study. Last year, a second large, randomized, placebo-controlled study was reported as part of the Women's Health Study. Recently a sex-specific meta-analysis of 6 trials, including these two, was published.

Insulin detemir (Levemir - Novo Nordisk) is the second long-acting basal insulin analog to be marketed in the US for treatment of both type 1 and type 2 diabetes. Detemir differs from human insulin by the elimination of the amino acid threonine in position B30 and the addition of a 14-carbon fatty acid chain at position B29. Insulin glargine (Lantus), the first long-acting insulin analog, has been available since 2001 and is usually given once daily.1 NPH insulin is an intermediate-acting basal insulin given twice daily. Basal insulins are usually combined with prandial doses of a rapid-acting insulin.

Taclonex ointment (Warner Chilcott/LEO Pharma), a combination of the vitamin D3 analog calcipotriene 0.005% (Dovonex) and the high-potency corticosteroid betamethasone dipropionate 0.064%, was recently approved by the FDA for treatment of psoriasis vulgaris in patients ≥ 18 years old.

A transdermal patch formulation of methylphenidate (Daytrana - Noven/Shire) has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥ 6 years old. Like other methylphenidate products, the patch is a schedule II controlled substance. According to the manufacturer, it will be available in pharmacies by the end of June.

Conivaptan hydrochloride (Vaprisol - Astellas), a vasopressin antagonist, has been approved by the FDA for short-term intravenous (IV) treatment of euvolemic hyponatremia in hospitalized patients. Euvolemic hyponatremia is most often caused by the syndrome of inappropriate ADH secretion (SIADH), or by hypothyroidism or adrenal insufficiency. The drug has not been approved for treatment of hypervolemic hyponatremia, which is associated with congestive heart failure (CHF), cirrhosis and renal disease. It should not be used in hypovolemic hyponatremia, such as occurs when fluid losses are replaced by excessive amounts of hypotonic solutions.

Many prescriptions for eye drops call for instillation of 1-2 drops. But Medical Letter consultants in ophthalmology seem to agree that all eye drops should generally be given in doses of only one drop.

The volume of a single drop can vary with the viscosity of the solution, the design of the dropper, and patient technique. The average volume of a drop is 35-50 microliters, but can be as high as 75 microliters. An eye brimming with fluid holds 30 microliters at best, so even one drop is often an overdose. A second either washes out the first or increases the possibility of systemic toxicity, and doubles the cost.

When two different drops are being used, they should be instilled at least 5 minutes apart.

A large mumps outbreak that began in Iowa in December 2005 has spread. About 40% of the cases have been in people 18-25 years old, many of whom are college students and had been vaccinated against the disease.

The FDA has approved the marketing of extended release (ER) ranolazine (Ranexa - CV Therapeutics) for treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs. It should be used in combination with a nitrate, a beta-blocker or the dihydropyridine calcium-channel blocker amlodipine (Norvasc), and appears to be more effective in men. The labeling for ranolazine specifies amlodipine as the calcium-channel blocker of choice because the use of other dihydropyridines with ranolazine has not been studied, and use with diltiazem (Cardizem, and others) or verapamil (Isoptin, and others) is contraindicated.

The FDA has approved lubiprostone (Amitiza - Sucampo/Takeda), a chloride channel activator, for treatment of chronic idiopathic constipation in adults. The only other prescription drug approved by the FDA for this indication (in 2004 for adults <= 65 years old) is tegaserod (Zelnorm), a partial agonist of serotonin that is also approved for constipation-predominant irritable bowel syndrome in women. Of course, numerous over-the-counter products are available for treatment of constipation.

The FDA recently approved the monoamine oxidase inhibitor (MAOI) selegiline in a transdermal (patch) formulation (Emsam - Bristol-Myers Squibb/Somerset) for treatment of major depressive disorder. Selegiline is also available in an oral formulation (Eldepryl, and others) for treatment of Parkinson's disease.

Anidulafungin (ay nid yoo la fun jin; Eraxis - Pfizer), a third intravenous echinocandin antifungal, has been approved by the FDA for treatment of esophageal candidiasis, candidemia, and other complicated Candida infections (intra-abdominal abscess or peritonitis).

Last year, a Medical Letter article reviewing colonoscopy preparations warned that oral sodium phosphate preparations, such as Fleet Phospho-Soda solution and Visicol tablets, could cause significant electrolyte disturbances and, rarely, renal failure (Med Lett Drugs Ther 2005; 47:53). A subsequent report documented acute phosphate nephropathy and renal failure in 21 patients who had used sodium phosphate before colonoscopy (GS Markowitz et al. J Am Soc Nephrol 2005; 16:3389). Seventeen of these patients were women and 14 were taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). The FDA recently issued an alert advising against use of oral sodium phosphate in patients with kidney disease or uncorrected electrolyte abnormalities and urges caution in patients taking drugs that may affect renal function such as diuretics, NSAIDs, ACE inhibitors or ARBs.

Preliminary results from a new study, unpublished but reported in a press release from the National Cancer Institute and widely disseminated in the public press, suggest that raloxifene (Evista) might be a better choice than tamoxifen (Nolvadex, and others) for prevention of breast cancer in high-risk postmenopausal women.

Acupuncture is the practice of inserting fine needles for therapeutic purposes into points on the skin known as acupoints. In traditional Chinese medicine theory, these points arefound along channels that conduct "qi" (pronounced "chee"), or energy. In addition to insertion of needles, acupoints can be stimulated by heat, electrical current or just pressure.

The FDA has approved a new genetic test to identify patients who may be at increased risk of severe toxicity when treated with the cancer chemotherapy drug irinotecan (Camptosar). The Invader UGT1A1 Molecular Assay (Third Wave Technologies) detects the UGT1A1*28 allele, a variation in the uridine diphosphate glucuronosyltranferase 1A1 (UGT1A1) gene. The FDA recently revised the safety labeling for irinotecan, recommending that the dosing of irinotecan be reduced for patients who are homozygous for the UGT1A1*28 allele.

Insulin glulisine (Apidra - Sanofi Aventis) is the third rapid-acting insulin analog to be marketed in the US, following insulin lispro (Humalog) and insulin aspart (Novolog). All three have a more rapid onset and shorter duration of action than regular human insulin. Rapid-acting insulin analogs are generally taken immediately before meals and are usually combined with a long-acting basal insulin.

Rituximab (Rituxan - Genentech), an anti-CD20 monoclonal antibody already marketed for treatment of B-cell non-Hodgkin's lymphoma, is now FDA-approved for use concurrently with methotrexate to treat moderate to severe rheumatoid arthritis in patients who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors. Rituximab selectively depletes CD20+ B cells, which apparently play a role in the autoimmune response and in the chronic synovitis associated with rheumatoid arthritis.

Deferasirox (Exjade - Novartis), an oral chelating agent, recently received accelerated approval from the FDA as an orphan drug for oral treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients >2 years old. Deferasirox is a tridentate (2 molecules of deferasirox bind to one atom of iron) chelating agent with high affinity for iron. It has much lower affinity for zinc and copper.

Telithromycin (Ketek) is an oral erythromycin derivative FDA-approved for treatment of mild to moderate community-acquired pneumonia, exacerbations of chronic bronchitis and acute bacterial sinusitis (Med Lett Drugs Ther 2004; 46:66). It is generally considered an alternative antibiotic because of its cost, potential for adverse effects including visual disturbances, exacerbation of myasthenia gravis, hepatotoxicity and drug interactions. A recent report (Ann Intern Med 2006; 144:415) described serious hepatotoxicity probably related to telithromycin in three patients, including one who died and another who needed a liver transplant. Many other oral antibiotics are available for treatment of community-acquired pneumonia, exacerbations of chronic bronchitis and acute bacterial sinusitis in adults (Med Lett Drugs Ther 2005; 47:78).

Clopidogrel (Plavix - Sanofi-Aventis and Bristol-Myers Squibb), an oral thienopyridine that inhibits platelet aggregation, is now being advertised directly to the public on television. Clopidogrel is approved by the FDA for secondary prevention of myocardial infarction (MI), stroke and other vascular events and for use in patients with acute coronary syndrome (unstable angina or non-ST-elevation MI), including those undergoing angioplasty. It is used off-label for patients with ST-elevation acute MI

Lenalidomide (Revlimid - Celgene), a thalidomide analog, has been approved by the FDA for treatment of patients with transfusion-dependent anemia due to myelodysplastic syndrome (MDS) associated with a 5q deletion cytogenetic abnormality and a low or low-intermediate risk of mortality and progression to leukemia (based on the International Prognostic Scoring System).

Now that glucosamine and chondroitin, 2 favorite over-the-counter remedies for painful osteoarthritis (OA) of the knee, have been at least somewhat discredited, some patients will be asking about alternatives. One of these is periodic intra-articular injection of a corticosteroid or hyaluronic acid preparation.

The FDA has approved a new spray formulation of the super-high-potency corticosteroid clobetasol propionate 0.05% (Clobex - Galderma) for treatment of moderate to severe plaque psoriasis in adults. Clobetasol propionate is also available as a cream, ointment, gel, solution, foam, lotion and shampoo.

Levalbuterol, the R-isomer of the beta-2 adrenergic agonist albuterol, is now available in the US as a metered-dose inhaler (Xopenex HFA - Sepracor) for treatment of asthma in patients ≥ 4 years old. Levalbuterol has been available since 1999 in a nebulizer solution for treatment of bronchospasm in patients ≥ 6 years old.1 Outside the US, albuterol is called salbutamol, and levalbuterol is levosalbutamol.

Avandaryl, a new fixed-dose tablet combining the thiazolidinedione rosiglitazone (Avandia) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved for patients already taking a combination of rosiglitazone and a sulfonylurea or those not adequately controlled on rosiglitazone or sulfonylurea monotherapy. Rosiglitazone is also available in a fixed-dose combination with metformin (Avandamet). Most patients with type 2 diabetes eventually require 2 drugs with different mechanisms to control hyperglycemia.

Atacept (Orencia - Bristol-Myers Squibb), an inhibitor of T-cell activation, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA) in patients who have not responded to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Coenzyme Q10, a fat-soluble antioxidant also known as ubidecarenone, ubiquinone and CoQ10, is marketed as a dietary supplement in the US, both as a single ingredient and in various combination products.

Methicillin-resistant Staphylococcus aureus (MRSA) infections, which have been a concern for many years, previously occurred primarily in hospitalized patients and those recently treated with antibiotics. In the past few years, there has been an increasing incidence worldwide of community-associated (CA) MRSA infections in patients without recent antibiotic exposure or contact with the healthcare system.

Nelarabine (Arranon - GlaxoSmithKline), a prodrug of the deoxyguanosine analog 9-β-D-arabinofuranosylguanine (ara-G), has been approved by the FDA for treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) that has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.

Hyperphosphatemia in end-stage renal disease can lead to secondary hyperparathyroidism, renal osteodystrophy, metastatic calcification and cardiovascular mortality. addition to dietary restriction of phosphorus and hemodialysis, drugs that bind phosphates in the gut are usually needed as well. Aluminum hydroxide is no longer recommended for long-term use because of concerns about its toxicity.

For patients with diabetes poorly controlled with a single oral drug, addition of a second drug with a different mechanism can be helpful. A fixed-dose combination (Actoplus met - Takeda) of two widely used antihyperglycemic drugs, the thiazolidinedione pioglitazone (Actos) and the biguanide metformin (Glucophage, and others), has been approved by the FDA for management of type 2 diabetes. It is indicated for patients already being treated with both pioglitazone and metformin or as second-line therapy for those not adequately controlled with either metformin or pioglitazone alone. Rosiglitazone, another thiazolidinedione, is also available in a fixed-dose combination with metformin (Avandamet).

The FDA has licensed Adacel (Aventis Pasteur) and Boostrix (GlaxoSmithKline), two new combination vaccines that include tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap), for use as a booster in adolescents and adults. In the past, older children and adults were not re-immunized against pertussis because of concerns about reactions to the whole-cell vaccine previously used in younger children. The CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) have recommended that either of the new Tdap vaccines replace routine tetanus-diphtheria (Td) boosters in adolescents 11-18 years old, and Adacel should replace Td boosters in adults 19-64 years old.

The physiologic changes that occur with aging can affect the pharmacokinetics and pharmacodynamics of many prescription and over-the-counter drugs, increasing the likelihood of adverse effects.

Chromium is marketed as a dietary supplement, usually containing 20-500 mcg of a chromium salt. It has been promoted for weight loss, muscle building, and for prevention and treatment of diabetes, among other claims. As a dietary supplement, chromium can be sold without proof of efficacy or safety.