OrganizedWisdom Health Blog

New Drugs Approved Summer 2010

New drugs not only offer hope, but possibly a better quality of life, for those awaiting new treatments. However, new drug approvals can also spark controversy. The FDA approved 17 new drugs this summer (June-August 2010). Many offer new promise, and one in particular promises a great deal of future debate.

Since nearly one in three Americans has high blood pressure, it isn't surprising that two of the 17 newly approved drugs are antihypertensives. The most recently approved drug is Tekamlo (aliskiren and amlodipine) from Novartis, a single-pill combination drug for high blood pressure. Tribenzor is a new three-in-one combination drug that is taken once-daily to treat high blood pressure.  

The most controversial newly approved drug is the emergency contraceptive ella (ulipristal acetate) that can prevent pregancy for up to 5 days after sex.  Plan B, the so-called morning after pill, is less effective and can only be used within 3 days of having sex. ella has been available as ellaOne in Europe since May 2009 and will be available to US women this fall.

Many are against the FDA approval of ella as a contraceptive when it can be used to induce abortion. Representative Chris Smith (R-NJ) says this classification may pave the way to “covertly allow federal funding for abortion." (1)  Supporters and opponents agree this approval highlights the increasing influence of the FDA on political ideology and will be entangled with future political and regulatory battles.

A promising new drug, Cuvposa (glypopyrrolate), is the first liquid treatment for children who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy. The FDA reports that 78% of children on this drug reached clinical improvement during trials. 

The 17 new drugs approved this summer with their indications are listed in Figure 1. New drugs for asthma (Dulera), enlarged prostate (Jalyn), migraine (Alsuma), osteoporosis (Prolia), acne (Veltin), and erectile dysfunction (Staxyn) are a sampling of 2010 FDA approvals.  

Figure 1: FDA Newly Approved Drugs Summer 2010 (June-August) 

Drug	Approval 2010	Company	Indication
Tekamlo (aliskiren and amlodipine)	August 26	Novartis Pharmaceuticals	Hypertension
ella (aliskiren and amiodipine)	August 13	HRA Pharma	Postcoital Contraception - emergency contraception
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate)  - Oral	August 5	Braintree Laboratories	Bowel Preparation – cleansing colon prior to colonoscopy
Xeomin (incobotulinumtoxinA)	July 30	Merz Pharmaceuticals	Cervical Dystonia, Blepharospasm
Cuvposa (glycopyrrolate) Oral Solution	July 28	Shionogi Pharma, Inc	Chronic Drooling in Children
Lastacaft (alcaftadine) Ophthalmic Solution	July 28	Vistakon Pharmaceuticals	Allergic Conjunctivitis - itchy eyes associated with eye allergies
Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) Tabs	July 23	Daiichi Sankyo, Inc.	Hypertension – once-daily treatment
Veltin (clindamycin and tretinoin) Gel - formerly Velac	July 16	Stiefel Laboratories, Inc.	Acne - antibiotic and retinoid for topical treatment of acne
Zuplenz (ondansetron) Oral Soluble Film	July 2	Strativa Pharmaceuticals	Prevention of Chemotherapy-Induced, Radiotherapy-Induced, and Postoperative Nausea and Vomiting
Glassia (alpha1-proteinase inhibitor Injection) - formerly AAT-IV	July 1	Kamada Ltd.	Alpha-1 Proteinase Inhibitor Deficiency – in adults with emphysema
Butrans (buprenorphine) Transdermal System	June 30	Purdue Pharma L.P.	Pain – management of moderate to severe chronic pain
Alsuma (sumatriptan) Injection	June 29	King Pharmaceuticals	Migraine, Cluster Headache
Dulera (mometasone furoate and formoterol fumarate) Inhaler	June 22	Merck & Co.	Asthma – in people 12 years of age and older
Staxyn (vardenafil) Orally Disintegrating Tablets	June 17	GlaxoSmithKline and Merck & Co.	Erectile Dysfunction
Jevtana (cabazitaxel) Injection	June 17	Sanofi-Aventis	Prostate Cancer - in combination with prednisone for hormone-refractory metastatic prostate cancer
Jalyn (dutasteride and tamsulosin) Capsules	June 14	GlaxoSmithKline	Benign Prostatic Hyperplasia – in men with enlarged prostate
Prolia (denosumab) Injection	June 1	Amgen Inc.	Osteoporosis – in women at high risk for fracture

      (1). Stein, Rob. FDA approves ella as a 5-day-after emergency contraceptive. The Washington Post. August 14, 2010. 

Past blog entries on trending health topics on OrganizedWisdom or popular health searches on the Web:

Popular Celebrity Cancer Searches for August 2010 
10 Healthiest Foods 
10 Trending Health Topics...Hot Off the Press 
5 Trending Health Topics: Health Questions You're Too Afraid to Ask 
10 Trending Health Searches: Crisis-Everywhere-You-Turn Edition (April 26-May 2) 
5 Trending Health Topics: Healthy Skin Edition

By Julie Bohlen, MBA/HCM, ELS

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Follow Friday: Featuring 5 Patient Experts

Meet these patient experts who rise above when it comes to inspiring and providing support to others. These individuals not only share their experiences and expertise, but they raise awareness and offer insights so that others can identify and be better informed.

1. @breathinstephen Marathons and severe asthma—no way? Think again. Stephen Gaudet has lived with severe refractory asthma since birth. Beating most odds, he has walked his way into the record books by becoming the first person with documented severe lung disease to finish the Boston marathon. Just this past April, he finished it again to raise awareness about current asthma research. His Breathin' Stephen blog is simply inspiring. He chronicles his fitness routine and shares tips for the benefit of others. His message is clear—physical fitness is critical for people with chronic lung disease.  His approach is motivating and commendable.
   
   
2. @accarmichael Cofounder of CureTogether and chronic pain sufferer, Alexandra Carmichael, shares quality health resources. CureTogether helps people anonymously compare health data to make more informed treatment decisions. This community allows patients to help each other and participate in data collection. Last year, CureTogether was a winner of the Mayo Clinic iSpot Competition for Ideas that Will Transform Healthcare. Check it out!
   
   
3. @ADHD_Hunter Want help and direction with ADHD and coexisting conditions in the family? A good place to turn is the outstanding ADHD Hunter's Hunter in a Farmer’s World blog. Chris, aka ADHD Hunter, shares insights and quality information on his ADHD and other conditions that his family lives with on a daily basis. He credits Thom Hartman for the Hunter in a Farmer's World concept, but uses this concept to paint a picture for those without ADHD to better understand the condition and support those who cope with ADHD. His What is Good ADHD Parenting? and related parenting posts are especially insightful.
   
   
4. @CancerVoicesSA Cancer survivor and Cancer Voices SA executive, Ashleigh Moore, contributes quality cancer resources and encourages those affected by cancer to connect with others. Cancer Voices South Australia was officially launched by the Minister for Health, John Hill, in November 2007. Ashleigh promotes ‘Raising a voice for those affected by cancer’ through advocacy,
   involvement, awareness, and information.  Check out this helpful cancer support site.
   
   
5. @BipolarChica Mental health blogger, Cristina Fender, shares quality and personal bipolar disorder insights. Cristina breaks through the taboo barrier and journals about her feelings, thoughts, and experiences while living with this disorder. Her HealthyPlaces Bipolar Vida blog chronicles her life as she "tries to open the blinds and see the sunshine." While she professes to not always win that battle, she sheds light for others struggling with bipolar disorder. 

Stay tuned as we feature other remarkable patient experts. If you know of someone who is worthy of our patient expert award, please use our contact form to recommend the Twitter profile of this worthy patient expert. 

by Julie Bohlen, MBA, ELS

Why you should never ignore shortness of breath (and other health lessons learned from celebs)

The OrganizedWisdom team was saddened to learn of Robin Williams' hospitalization and aortic valve replacement. While he surely gave his family, friends, and fans a big scare, doctors say the surgery should be routine (just as long as the patient can refrain from telling jokes while they're holding their scalpels).

The silver lining is that every time a celebrity comes forward to disclose a health condition, thousands of average Joes pay closer attention to their own symptoms and get them checked out. In this case, Williams complained of shortness of breath, which can be a symptom of asthma, COPD, heart attack, and heart failure. It's definitely something to tell your doctor about if you've experienced it.

OrganizedWisdom has tracked down great resources to help you learn more about celebs with conditions you may be curious about. Here are some highly searched stars and the valuable health lessons they've shared.

• Sometimes major fatigue is a sign that you need more than just a day off: Halle Berry and Diabetes
• Extreme pain in feet and hands is nothing to shrug off: Kathleen Turner and Rheumatoid Arthritis
• A bout of indigestion can be an early sign of something worse: Anne Rice and Diabetes
• Many skin conditions stay with you for life, but new treatments can help you manage: Leann Rimes and Psoriasis

More on Celebrities and Health at OrganizedWisdom

One of our favorite celebrity health blogs: Celebrity Psychings