Top Ten Health Stories of the Year 2010

The year 2010 saw a lot of ‘hustle and bustle’ in the medical circle. Here are the Top 10 stories as viewed by eMedinewS.

1. Overhauling of Medical Council of India: The major story of the year was the arrest of MCI President Dr. Ketan Desai, dissolution of the MCI; appointment of six out of seven Board of Governors; subsequent release of Dr. Ketan Desai on bail, common entrance exam for MBBS; reduction in forensic faculty requirement; increase in retirement age to seventy and the suspense behind 7th seat of Board of Governors etc.
2. Medical Council of India action against Indian Medical Association: MCI took action against the IMA President and Secretary for violation of MCI Ethics on the ground that IMA should not have endorsed Pepsi products. The IMA had to approach High Court to take a stay. The matter is now in the High Court. Is that a start of MCI actions against ethics violations? Will it act against the cut system?
3. Delhi Bug: A huge controversy arose when British Medical Journal broke a story about NDM1 bug being named after New Delhi. The medical circle in India said that it was unfair and was an attempt to sabotage the medical tourism in India. The new bug is a gram negative bacteria showing resistance to all present antibiotics. New Delhi metallo–beta–lactamase (NDM–1) is an enzyme that makes bacteria resistant to a broad range of beta–lactam antibiotics. These include the antibiotics of the carbapenem family, which are a mainstay for the treatment of antibiotic–resistant bacterial infections. The gene for NDM–1 is one member of a large gene family that encodes beta–lactamase enzymes called carbapenemases. Bacteria that produce carbapenemases are often referred to in the news media as “superbugs” because infections caused by them are difficult to treat. Such bacteria are usually only susceptible to polymyxins and tigecycline. NDM–1 was first detected in a Klebsiella pneumoniae isolate from a Swedish patient of Indian origin in 2008. It was later detected in bacteria in India, Pakistan, the United Kingdom, the United States, Canada, Japan and Brazil. The most common bacteria that make this enzyme are Gram negative such as Escherichia coli and K. pneumoniae, but the gene for NDM–1 can spread from one strain of bacteria to another by horizontal gene transfer.
4. H1N1 havoc: H1N1 created great havoc, but ultimately, proved to be a ‘much hyped’ virus with mortality even lower than the regular human flu virus. Most of the hospitals who had started special H1N1 virus wards, now do not have these wards.
5. Chikungunya epidemic: The latest epidemic in the North India was that of Chikungunya with patients presenting with fever, rash and joint pains. It complicated the pre–existing dengue epidemic in the society.
6. Dengue with a difference: This year dengue was different than other years, came with more GI symptoms, pancreas involvement, dengue hepatopathy and lot of skin reactions. The platelet count dropped to less than 10000 but most required no platelet transfusion.
7. Diabetes diagnosis: The year saw a new advancement where A1C is to be used for diagnosis of diabetes and not fasting sugar. An A1C >6.5% means diabetes.
8. New pill for HIV prevention: A new pill is now available for HIV prevention along with condoms. It is to be used before the act and continues for seven days. In a trial involving nearly 2,500 HIV–negative, but high risk, gay men in six countries, researchers found that a combination antiretroviral pill (tenofovir and emtricitabine) reduced the risk of HIV infection by 44%, compared with placebo. When scientists looked more carefully at the study volunteers who took the medication most faithfully, on a daily basis, they found that the risk of contracting HIV was even lower — 73% lower than the placebo group. More studies will need to confirm the benefit of antiretrovirals in the prevention of HIV, and public health experts warn that even if the results hold up, it would not replace the best method of prophylaxis: safe sex and consistent use of condoms. That’s because the way so–called pre–exposure prophylaxis, or PrEP, works is to load up high–risk people with HIV–disabling antiretroviral drugs before exposure to the virus, which allows the medication to hit HIV as early as possible. But the drugs do not work as a vaccine would, by priming the immune system to actually prevent infection.
9. National Programme for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) started in the country:At last, Govt. of India, Ministry of Health and Family Welfare has started the above program.
10. New drug for premature ejaculation: The year ended with the launch of an SOS drug for premature ejaculation. This will be breakthrough for the community. Premature ejaculation, the most common sexual problem apart from erectile dysfunction, has been often found to put marriages under strain. While the existing drugs, which are not specific to treat premature ejaculation, need to be taken regularly, the new pill can be popped just a few hours before intercourse. It works by altering levels of serotonin, a chemical in the brain. The drug, dapoxetine, comes from a family of drugs called selective serotonin reuptake inhibitors, which block the reabsorption of the neurotransmitter serotonin.

Key findings from American Heart Association (AHA) 2010 scientific sessions

The American Heart Association (AHA) 2010 Scientific Sessions took place in Chicago, Illinois, November 13-17, 2010.

Key trials presented at the sessions include:

• ADVANCE: New LVAD equivalent to HeartMate II, nonrandomized study shows
• RAFT: CRT shows survival benefit for patients with class 2 and 3 HF who have low EF and wide QRS
• EMPHASIS-HF: Eplerenone shows large benefits in milder heart failure
• ASCEND HF: Nesiritide safe but of limited dyspnea benefit in acute HF
• ROCKET AF: Rivaroxaban noninferior to warfarin, but superiority analyses at odds
• CLOSURE I: No overall benefit, no reduction in stroke or TIA with PFO closure
• GRAVITAS: No benefit of doubling dose in clopidogrel nonresponders
• P-OM3: Omega-3 PUFA caps don't suppress paroxysmal AF in randomized trial
• BASKET-PROVE: DES as safe as bare-metal stents in larger coronary arteries, with less TVR 
• DEFINE: Large effects on LDL and HDL cholesterol with CETP inhibitor anacetrapib
• SYMPLICITY HTN: Catheter-based renal denervation reduces BP in patients with resistant hypertension
• ASCOT CRP: Analysis fuels debate over JUPITER-based CRP indication for statins
• ACT: No benefit of N-acetylcysteine to reduce contrast-induced nephropathy

Some drug interactions

Questioner: Edie
Question: My 85 year old mother has been taking some form of sleeping pills for the past 50 years the last 20 years at least has been restoral she is prescribed 30 mg. (there is times she binges and takes 2 pills a night) She also takes Xanax, Tylenyol with Codeine.  Should someone her age (or any age) be taking this much medication.  She has recently started drinking again.  What are the dangers/risks of her taking this much medication?  I am working with her Dr. to take the administration of the medications out of her hands as she is getting more and more abusive.
Answer: There is risk of major interaction between Tylenol (acetaminophen) and alcohol. Consumption of alcohol may increase the risk of acetaminophen-induced hepatotoxicity. There is moderate risk of interaction between (1) alcohol with codeine, Xanax (alprazolan) and Restoril (Temazepam). CNS depressant effects of these drugs may be potentiated. (2) codeine, alprazolam and Temazepam with each other.  Central nervous system- and/or respiratory-depressant effects may be additively or synergistically increased in patients taking multiple drugs that cause these effects, especially in elderly or debilitated patients.
There is no need for her to take codeine, acetaminophen or alcohol. The are not helpful in getting to sleep. Stopping these three will dramatically reduce risk of adverse effects. 

Patient of prostatitis due to E.coli not responding to ciprofloxacin, levofloxacin and doxycycline

Questioner: Wong
Question- I have been diagonsed with prostatitis. The offending organism is E.coli. I have been treated with Ciprofloxacin for 7 days and levofloxacin for 6 weeks with no improvement in symptoms. A later culture and sensitivity test showed that the bacteria is resistant to ciprofloxacin. Then I tried doxycycline for a month with no improvement. I asked my doctor to test other prostate-penetrating drugs on the bacteria, but he said he can't dictate what the lab does. I'm thinking about using sparfloxacin, gatifloxacin, or minocycline, but due to the E.coli being resistant to ciprofloxacin and lack of symptomatic response to doxycycline, do you think that the bacterial would be resistant to these drugs as well?


Please give your opinion (with reasoning) in comments.

New molecular entities (NMEs) approved in 2010

• Asenapine (Saphris, Merck & Co., Inc.)
• Bepotastine (Bepreve, ISTA Pharmaceuticals)
• Dronedarone (Multaq, Sanofi-aventis)
• Liraglutide (Victoza, Novo Nordisk)
• Tocilizumab (Actemra, Genentech)
• Ustekinumab (Stelara, Centocor Ortho Biotech)
• For details see http://www.medscape.com/viewarticle/731720

• New Drug Review 2010

  Jack DeRuiter, PhD; Pamela L. Holston, RPh, BS, BA
  Posted: 11/10/2010; US Pharmacist © 2010 Jobson Publishing

Onabotulinumtoxin A for Migraine

The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox; Allergan Inc) for headache prophylaxis in patients with adult chronic migraine who suffer headaches on 15 or more days per month, each lasting more than 4 hours.

    To treat chronic migraine, onabotulinumtoxinA is given approximately every 12 weeks as multiple injections around the head and neck. The recommended dose is 155 units (1 mL) divided across 7 head and neck muscles, administered at intervals of at least 12 weeks.

The most common adverse reactions reported by patients being treated with onabotulinumtoxinA for chronic migraine were neck pain (9%) and headache (5%).

Marketed as Botox and Botox Cosmetic, onabotulinumtoxinA has a boxed warning that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism.Symptoms include swallowing and breathing difficulties that can be life-threatening.

 Source: FDA New Drug Web site (www.fda.gov)

Which is more important for universities and colleges-Teaching or Research?

In universities here, research is the main criterion for appointment as well as promotion and  good researchers generally pay less attention to teaching. However, I feel one cannot remain abreast with recent developments in the field without being involved in research and the teaching will be very dogmatic. Also, only researchers can infuse a spirit of enquiry and innovation in their students.So, there is a need to balance the 2, not their separation. Quality of teaching must be an equal, if not more important, criterion for grading and promotion of teachers. What do you say?

Fish oil: benefits versus harms

There are reports about prooxidant effects and aging accelerating effects of fish oils. Whatever we ingest has benefits as well as harms and we have to weigh the two. In case of fish oil, the benefits far outweigh the harms. 0.5-1.8 g/day is the recommended dose for healthy people. Higher doses will be harmful. See http://healthyomega3.com/fish-oil-dosage/

Great advice on how to help your child (and yourself) sleep well

Excerpts from 'The No-Cry Sleep Solution for Toddlers and Preschoolers' by Elizabeth Pantley

Gentle Ways to Stop Bedtime Battles and Improve Your Child's Sleep

The following sleep ideas are of value to almost any sleeper, regardless of age. These tips can bring improvement not only in your child’s sleep, but also in her daytime mood and, last, but certainly not least – improvements in your own sleep and outlook as well.

• 1. Maintain a consistent bedtime and awaking time seven days a week.Your child’s biological clock has a strong influence on her wakefulness and sleepiness. When you establish a set time for bedtime and wake up time you “wind” your child’s clock so that it functions smoothly.Aim for an early bedtime. Toddlers and preschoolers respond best with a bedtime between 6:30 and 7:30 P.M, and most children will actually sleep better and longer when they go to bed early.
• 2. Encourage regular daily naps.Daily naps are important since an energetic child can find it difficult to go through a long day without a rest break. A nap-less child will often wake up cheerful and become progressively moodier, fussier or hyper-alert as the day goes on, and as he runs out of steam. Moreover, the length and quality of naps affects nighttime sleep – good naps equal better night sleep.
• 3. Set your child’s biological clock.Take advantage of your child’s natural biology so that he’s actually tired when bedtime arrives. Darkness causes an increase in the release of melatonin, the body’s sleep hormone, and it is the biological “stop” button. You can help align your child’s sleepiness with his bedtime by dimming the lights in your home during the hour before bedtime. Exposing your child to morning light is like pushing a “go” button in her brain — one that says, “Time to wake up and be active.” So keep your mornings bright!
• 4. Develop a consistent bedtime routine.Routines create feelings of security. A consistent, peaceful bedtime routine allows your active child to transition from the motion of the day to the tranquil state required to fall asleep. A specific before-bed routine naturally and easily ends with sleep.An organized routine helps you coordinate the specifics that must occur before bed: bath, pajamas, tooth-brushing. It helps you to function on auto-pilot at the time of day when you are most tired and least creative.
• 5. Create a cozy sleep environment.You may have never given much thought to where your child sleeps, but it can be one of the keys to better sleep. Make certain the mattress is comfortable, the blankets are warm enough, the room temperature is right, pajamas are comfy and the bedroom is welcoming.
• 6. Provide the right nutrition to improve sleep.Foods can affect energy level and sleepiness. Carbohydrate-rich foods can have a calming effect on the body, while foods high in protein or sugar generate alertness, particularly when eaten alone. A few ideas for pre-bedtime snacks are: whole wheat toast and cheese, bagel and peanut butter, oatmeal with bananas, or yogurt and low-sugar granola.Vitamin deficiencies that are due to consistently unhealthy food choices can affect a child’s overall health, including her sleep. Make your best effort to provide your child with a daily assortment of healthy foods.
• 7. Help your child to be healthy and fit.Many children don’t get enough daily physical activity. Too much TV watching, coupled with a lack of activity amounts to a sedentary lifestyle – which prevents good sleep. Children who get ample daily physical exercise fall asleep more quickly, sleep better, stay asleep longer and wake up feeling more refreshed.Avoid physical activity in the hour before bedtime, though, since exercise is stimulating and has an alerting effect – so they’ll be jumping on the bed instead of sleeping in it!
• 8. Teach your child how to relax and fall asleep.Many children get in bed but aren’t sure what to do when they get there! It can be helpful to follow a soothing pre-bed routine that helps create feelings of sleepiness. A common component of the bedtime ritual is story time, and for good reason. A child who is listening to a parent read, or tell a tale, will tend to lie still and focus on the story. This quiet stillness will allow him to become sleepy.

Commit to working with these eight ideas and you’ll likely see improvements in your child’s sleep, and yours too.

Excerpted with permission by McGraw-Hill Publishing from The No-Cry Sleep Solution for Toddlers and Preschoolers (McGraw-Hill 2005).

Statistical education and general interest: free resources

Just came across a great resourse to learn statistics in an interesting way real life situations and examples. 'Statistics for the terrified'.Statistical education and general interest: free resources

The Telegraph - | Nation | Education boost by MCI

New proposals from MCI have eased norms for new medical colleges to give boost to medical education.
1. Only 10 acre land is required
2. Binary campus allowed where hospital is situated within 5 Kms from teaching block having preclinical departments like pharmacology.
3. Lesser no. of beds required in hospital
4. Govt. can open medical colleges associated with district hospitals
The Telegraph - Calcutta (Kolkata) | Nation | Education boost by MCI

Effects of glycemic load on metabolic risk markers... [Am J Clin Nutr. 2010] - PubMed result

A recent study suggests that diet with a decreased Glycemic Load does not ameliorate metabolic risk markers such as fasting plasma glucose, insulin , serum total cholesterol , LDL-cholesterol , HDL-cholesterol ,triacylglycerol, high-sensitivity C-reactive protein, interleukin-6, tumor necrosis factor-alpha, monocyte chemoattractant protein and prothrombotic plasminogen activator inhibitor 1 in overweight subjects. This means that such subjects should concentrate on reducung weight and cholesterol rather than restricting sugar intake. Effects of glycemic load on metabolic risk markers... [Am J Clin Nutr. 2010] - PubMed result

The Limits of Antidepressants: Exploring the Alternatives

Antidepressants (TCAs as well as SSRIs) have been found to be similar to palcebo in mild to moderate depression. So, what does work for these patients?
1. Fish
2. Exercise
3. 5-Hydroxytryptophan (5-HTP) supplement
4. To understand their feelings and address unmet needs.
Read more: Christiane Northrup, MD: The Limits of Antidepressants: Exploring the Alternatives

Selecting medical students : Need for a change

Do the medical entrance tests correctly measure a student's ability to become a good doctor? Research shows otherwise. Here are some excerpts from a recent article published in The Lancet.
'performance in the premedical sciences is inversely associated with many of the personal, non-cognitive qualities so central to the art of medicine.'...
students' undergraduate science grades and MCAT science scores were associated with grades in the first 2 years of medical school, but were, “almost completely unrelated to performance in the fourth year and to faculty rating of general and clinical competence”....
students who did better in science were, “narrower in interests, less adaptable, less articulate, and less comfortable in interpersonal relationships”....
students who were most successful in the sciences, “have an impersonal orientation: they are not very interested in others”. ...
students who did the best in the premedical sciences scored lower on standardised measures of empathy and tended to be “shy”, “submissive”, “withdrawn”, or “awkward and ill at ease socially”, characteristics the author suggested are, “the antithesis of what most of us would want in a clinician”....
In response to growing data that balancing cognitive and non-cognitive strengths of applicants does not compromise eventual medical quality, some medical schools in the UK and USA have either adopted, or are evaluating, alternative admission criteria. A leader in this area has been McMaster Medical School in Canada with its “Multiple Mini Interview” used to assess psychological and personality aspects of potential students. The Humanities and Medicine Program of the Mount Sinai School of Medicine in New York offers another example.
Read more: 'Science as superstition: selecting medical students : The Lancet

Free online database of ADME, PK, and physicochemical data

Free online database of marketed drugs
ADME, PK, and physicochemical data
Aid your drug discovery and development

Features

Search the database for phys-chem, ADME and PK
properties of marketed drugs

Free online access via www.cloegateway.com
2D and 3D visualisation tools for viewing the relationships between ADME and physicochemical properties
All drugs are classified using the WHO ATC classification index, allowing identification of drugs by therapeutic area
Data compiled from Cyprotex in vitro ADME testing and literature values

SciVerse

Effective August 28, 2010 ScienceDirect, Scopus and the targeted web content from Scirus have been integrated within one platform - SciVerse.
(NB All existing URLs will remain active and there will be no interruption of inward or outward links to your subscribed content.)
Go to www.sciverse.com to access the SciVerse platform.
The home page for SciVerse is the new SciVerse Hub beta from which users can access:
Search results across ScienceDirect, Scopus and scientific web content, ranked by relevance and without duplication
Three free applications that enhance search and discovery, allowing you to:
Search only the methods/experimental procedures sections of the articles in ScienceDirect
See search results in full sentences to help find the right content faster
See a list of the most prolific authors for a given search topic
For more information (including answers to frequently asked questions) about SciVerse and the new releases of ScienceDirect and Scopus, please visit www.info.sciverse.com

Why Starved Flies Need Less Sleep - Science News

I was wondering how we can do our normal routine work, even more work, in Ramadhan despite getting less than normal sleep. Also how do saints (buzurgs) cope up with less sleep and do a lot of mental work during the day? Here is the research which points to the answer. Fasting and having less food prevents building up of substances that induce sleep. For details see Why Starved Flies Need Less Sleep - Science News

Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure

The US Food and Drug Administration (FDA) approved Tekamlo (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine. Since Aliskiren is already in the market, it needs to be seen which one of the 3 classes of drugs tergeting the renin-angiotensin-aldosterone system (angiotensin receptor blockers, ACE inhibitors and renin inhibitors) is a better alternative for hypertensive patients. In our medical school we are initiating a trial comparing newer angiotensin receptor blockers and ACE inhibitors. I do not know whether aliskiren is available in India and at what cost.

Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure

Development and Validation of a New Prescription Quality Index - Hassan - 2009 - British Journal of Clinical Pharmacology - Wiley Online Library

Prescription Quality Index- A new index to measure quality of prescriptions.
Prescription Quality Index• Many studies raise serious questions about the prescribing appropriateness and prescription quality. However, there is a lack of a single measure which will capture all facets of prescription quality.

• Evaluation of prescriptions was usually based on expert judgement of practitioners.

• Definition of prescription quality, reference model, validity and reliability of the measurement tools, and other data such as the number, type and severity of diagnosis of patients were usually insufficient or lacking.

What this study adds

• The Prescription Quality Index (PQI) was developed with a strong structural foundation and was able to capture the clinical, clerical, and legal requirement of a prescription.

• Extensive psychometric testing was performed on the PQI and the new tool demonstrated acceptable validity and reliability.

• The PQI has been shown to be a valid, reliable and responsive tool to measure quality of prescriptions in chronic diseases.

Development and Validation of a New Prescription Quality Index - Hassan - 2009 - British Journal of Clinical Pharmacology - Wiley Online Library

Free Technology for Teachers: 140 New Things Being Tried In Classrooms This Fall

A google presentation of 142 new tips innovative tech-savvy teachers around the world are trying in their classrooms. If you have any new idea for your classroom, please leave a comment.
Free Technology for Teachers: 140 New Things Being Tried In Classrooms This Fall

Career Advice: Do You REALLY Want to Be a Professor? - Inside Higher Ed

Time to slow down and reflect: A must read article for all those who are in an academic career and do not feel very satisfied. Career Advice: Do You REALLY Want to Be a Professor? - Inside Higher Ed

Hypolipidemic agents

Nice Presentation on drugs for treatment of dyslipidemia:

Hypolipidemic agents

View more presentations from Dr.Bhargav Purohit.

SPICES in Medical Education

Found a nice article on newer techniques of Medical Education. SPICES refers to to six main concepts in medical education—student centred teaching, problem based learning, an integrated curriculum, community based teaching, electives with a core, and the use of systematic methods. All the six concepts have been succinctly explained along with advantages and disadvantages of each. Very useful for persons appearing for interviews for faculty position. Spicing up Medical Education: Introduction

Medical Education Home - Medical Education

Medical Education Home - Medical Education

New anticancer nanoparticle drug containing small interfering RNAs

Agents tageting small interfering RNAs (siRNA) for use in cancer have been developed. The phase 1 clinical trials are over and the results were recently published in Nature.

CALAA-01 is a nanoparticle drug containing small interfering RNAs targeted to ribonucleside reductase M2. This is used in solid tumors that are refractory to therapy.

This opens an entirely new class of anticancer agents.

Is Religiosity or Spirituality Protective For Heart Disease?: Commentary

Is Religiosity or Spirituality Protective For Heart Disease?: Commentary

Sizing up Nanoparticles - The Scientist - Magazine of the Life Sciences

Sizing up Nanoparticles - The Scientist - Magazine of the Life Sciences

Gut bacteria are what we eat - The Scientist - Magazine of the Life Sciences

Gut bacteria are what we eat - The Scientist - Magazine of the Life Sciences

A new strategy normalizes blood sugars in diabetes

Diabetes-obesity link explored.

A new strategy normalizes blood sugars in diabetes

BioTechniques - The "hottest" researcher of 2009

BioTechniques - The "hottest" researcher of 2009

BioTechniques - Logical and pedagogical

biochemistry on the Web for everyone to see, use, and enjoy.

BioTechniques - Logical and pedagogical

[http://employees.csbsju.edu/hjakubowski/classes/ch331/bcintro/default.html ]

New drug approvals

Drugs Approved for New Purposes or as Novel Formulations in 2009

Generic Name	Traditional Use	New Form	New Use
benzyl alcohol	preservative	5% lotion	head lice
bromocriptine	acromegaly, hyperprolactinemia, Parkinson disease	0.8mg tablet	type 2 diabetes mellitus
calcitriol	secondary hyperparathyroidism, hypocalcemia	0.0003% ointment	psoriasis
capsaicin	muscle or joint pain	8% transdermal patch (Rx)	postherpetic neuralgia
ciprofloxacin	superficial ocular infections	0.2% otic solution	otitis externa
diclofenac	analgesia, ankylosing spondylitis, arthritis. dysmenorrhea, migraine	1.5% solution in DMSO for topical application	osteoarthritis of the knee
guanfacine	hypertension	1mg, 2mg, 3mg, 4mg extended-release tablets	attention deficit hyperactivity disorder
ibuprofen	pain, inflammation, fever	IV solution for administration in health care settings (Rx)	analgesia
ketoprofen	arthritis	12.5mg cinnamon or peppermint flavored oral film (OTC)	minor pain
sildenafil	erectile dysfunction	10mg/12.5mL injection	pulmonary arterial hypertension
sumatriptan	migraine	6mg subcutaneously (needle-free system)	migraine
tadalafil	erectile dysfunction	20mg tablet	pulmonary arterial hypertension
tranexamic acid	hemophilia (post-tooth extraction hemorrhage)	650mg tablet	menorrhagia
treprostinil	pulmonary arterial hypertension (continuous IV infusion)	0.6 mg/mL inhalation	pulmonary arterial hypertension
vigabatrin*	orphan drug for infantile spasms (West syndrome)	500mg tablet	refractory complex partial seizures

New Drugs Licensed in 2009 with Mechanisms Similar to Previously Approved Drugs

Generic Name	Mechanism of Action	2009 FDA Approved Indication	Pharmacologically Similar Agents
abobotulinum toxin type A (botulinum toxin type A neurotoxin complex produced from a proprietary fermentation process)	acetylcholine release inhibitor	Treatment of cervical dystonia and cosmetic treatment of facial lines	onabotulinumtoxinA (botulinum toxin type A)
			rimabotulinumtoxinB (botulinum toxin type B)
asenapine	serotonin, dopamine, alpha adrenergic, and histamine receptor antagonist	• Treatment of manic or mixed episodes associated with bipolar I disorder	clozapine, loxapine, olanzapine, quetiapine
		• Acute treatment of schizophrenia
bepotastine	ophthalmic H1-receptor antagonist and inhibitor of the release of histamine from mast cells	Treatment of itching associated with allergic conjunctivitis	cromolyn, lodoxamine, nedocromil, pemirolast
besifloxacin	ophthalmic fluoroquinolone antibiotic	Treatment of bacterial conjunctivitis	ciprofloxacin, gatifloxacin, levofloxacin, ofloxacin, moxifloxacin
canakinumab	anti-human-IL-1β monoclonal antibody	Treatment of cryopyrin-associated periodic syndromes	anakinra, rilonacept
dexlansoprazole (R-enantiomer of lansoprazole)	(H+,K+)-ATPase inhibitor	• Management of erosive esophagitis	esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole
		• Treatment of heartburn
dronedarone	potassium, calcium, and sodium channel blocker	Therapy of atrial fibrillation or flutter	amiodarone
everolimus	inhibitor of mTOR kinase activity	Treatment of advanced renal cell carcinoma	temsirolimus
febuxostat	xanthine oxidase inhibitor	Management of hyperuricemia	allopurinol
ferumoxytol (superpara-magnetic iron oxide coated in a carbohydrate shell)	hematopoietic	Treatment of iron deficiency anemia associated with chronic kidney disease	iron dextran, iron sucrose, sodium ferric gluconate complex
golimumab	tumor inhibitor necrosis factor α	Treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis	adalimumab, certolizumab, etanercept, infliximab,
iloperidone	dopamine, serotonin, and norepinephrine receptor antagonist	Treatment of schizophrenia	paliperidone, risperidone, ziprasidone
milnacipran	selective serotonin and norepinephrine reuptake inhibitor	Management of fibromyalgia	desvenlafaxine, duloxetine, venlafaxine
ofatumumab	monoclonal antibody against CD20	Treatment of chronic lymphocytic leukemia	rituximab
pazopanib	multi-tyrosine kinase inhibitor	Treatment of advanced renal cell carcinoma	dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, sunitinib
pitavastatin	HMG CoA reductase inhibitor	Management of hypercholesterolemia	atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin
pralatrexate	folate analogue metabolic inhibitor	Treatment of relapsed or refractory peripheral T-cell lymphoma	methotrexate, pemetrexed
prasugrel	platelet P2Y12 receptor antagonist	Management of acute coronary syndrome	clopidogrel, ticlopidine
romidepsin	histone deacetylase inhibitor	Treatment of cutaneous T-cell lymphoma	vorinostat
saxagliptin	dipeptidyl peptidase-4 inhibitor	Adjunct treatment for type 2 diabetes mellitus	sitagliptin
telavancin (semi-synthetic vancomycin derivative)	lipoglycopeptide antibacterial	Treatment of complicated skin and skin structure infections caused by susceptible isolates of gram-positive microorganisms	daptomycin, teicoplanin, vancomycin
tolvaptan	vasopressin V2-receptor antagonist	Treatment of hyponatremia	conivaptan

New Pharmacological Drug Classes Introduced in 2009

Pharmacologic Class	First to be Marketed in the U.S.	FDA Approved Indication
endoperoxide/quinoline combination schizontocide	artemether/lumefantrine (coartem)	Treatment of acute, uncomplicated malaria
plasma kallikrein inhibitor	ecallantide (kalbitor)	Treatment of acute attacks of hereditary angioedema
monoclonal antibody against the p40 protein subunit of interleukin-12 and -23	ustekinumab(stelara)	Treatment of moderate to severe plaque psoriasis