Global Threat of Antibiotic Resistance – The UN World Health 
Organization has published a report which “… makes a clear case that 
resistance to common bacteria has reached alarming levels in many 
parts of the world and that in some settings, few, if any, of the 
available treatments options remain effective for common 
infections …” – The report focuses on “… antibiotic resistance in 
seven different bacteria responsible for common, serious diseases such 
as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary 
tract infections and gonorrhoea. The results are cause for high 
concern, documenting resistance to antibiotics, especially ‘last 
resort’ antibiotics, in all regions of the world … The report 
reveals that key tools to tackle antibiotic resistance – such as 
basic systems to track and monitor the problem – show gaps or do not 
exist in many countries … Other important actions include preventing 
infections from happening in the first place – through better 
hygiene, access to clean water, infection control in health-care 
facilities, and vaccination – to reduce the need for antibiotics. WHO 
is also calling attention to the need to develop new diagnostics, 
antibiotics and other tools to allow healthcare professionals to stay 
ahead of emerging resistance …”

The first study used accelerometers to monitor 7 days of physical 
activity (light or moderate in intensity) among some 1800 adults over 
age 49 who had knee osteoarthritis or were at risk for it. At 2 years’ 
follow-up, even light-intensity activities were significantly related 
to avoidance of disability onset or progression.

The second study examined the prognostic value of grip strength, chair-
rise speed, and standing balance in some 2800 adults (age at baseline, 
53 years) followed up after 13 years. Those in the lowest quintile of 
composite scores had nearly quadruple the risk for all-cause 
mortality, compared with those in the highest quintile of achievement.

To avoid disability or early death, an editorialist suggests that 
increasing light activity by over an hour a day (say, by walking 
around during television commercials) “might do the trick.”

BMJ study on knee arthritis

Clinicians may offer oral cannabis extract, tetrahydrocannabinol, or 
cannabinoid spray to patients with multiple sclerosis to ease patient-
reported spasticity and pain (excluding central neuropathic pain), 
according to new guidelines on alternative therapies for MS from the 
American Academy of Neurology. Clinicians should counsel patients, 
however, that cannabis is likely ineffective at improving objective 
measures of spasticity.

Other conclusions based on an evidence review in Neurology include:

Cannabis spray may be offered to reduce urinary frequency.
Magnetic therapy is probably effective for reducing fatigue and 
ineffective for treating depression.
Gingko biloba does not improve cognition.
A low-fat diet with omega-3 supplementation is probably ineffective 
for limiting relapses, disability, fatigue, or MRI lesions.
Neurology article

Injectable corticosteroids given via epidural to treat back and neck 
pain may cause “rare but serious” complications — paralysis, stroke, 
vision loss, and death — the FDA cautioned on Wednesday. The agency 
will require a label change to warn of these risks.

The warning follows a review of serious neurologic adverse events that 
occurred within minutes to 48 hours after epidural injections. Many of 
these complications were not reversible, according to the FDA report.

To date, the safety and efficacy of epidural corticosteroid injections 
have not been proven, says the agency, which also notes that 
corticosteroids have not been approved for this indication despite 
their widespread use. An advisory committee will meet later this year 
to discuss the benefits and risks of epidural injections.

FDA MedWatch safety alert

The FDA has approved the first human papillomavirus DNA test for women 
aged 25 and older that can be used as a stand-alone tool for primary 
cervical cancer screening.

The “cobas HPV Test”, which identifies HPV-16, HPV-18, and 
twelve other high-risk strains, was initially approved in 2011 for use 
in tandem with, or as a follow-up to, a Pap test.

Patients who test positive for HPV-16 or -18 should undergo a 
colposcopy, while those who test positive for any of the other high-
risk HPVs should undergo a Pap test to determine whether a colposcopy 
is warranted.

FDA news release

The FDA has approved Grastek, a second sublingual immunotherapy to 
treat grass pollen allergies. (The first sublingual immunotherapy for 
grass allergies, Oralair, was approved earlier this month.) The new 
tablet contains Timothy grass extracts and is indicated for patients 
aged 5 to 65 years.

In December 2013, FDA advisers called for postapproval studies to test 
Grastek’s safety in children aged 5 to 11 years, citing side effects 
such as lip swelling and oral blistering.

Reuters story (Free)
By Kristin J. Kelley

The FDA has approved Ragwitek to treat hay fever, with and without 
conjunctivitis, caused by short ragweed pollen. The pill, to be taken 
sublingually, contains an extract of short ragweed pollen.

Adults should take Ragwitek daily for 12 weeks before ragweed pollen 
season begins and should continue to do so during the season. It will 
contain a boxed warning alerting patients of the potential for severe 
allergic reactions.

FDA news release

The FDA is discouraging clinicians from using laparoscopic power 
morcellation for uterine fibroids because the procedure can cause 
undiagnosed uterine cancer to spread, the agency announced on 
Thursday. It stopped short of banning the procedure.

An FDA analysis found that roughly 1 in 350 women undergoing 
hysterectomy or myomectomy for fibroids has unsuspected uterine 
sarcoma. In such cases, laparoscopic morcellation, which involves 
cutting tissue into smaller pieces for easier removal, can spread the 
cancer within the abdomen and pelvis.

Roughly 50,000 of these procedures are done in the U.S. annually, and 
the FDA has received about a dozen reports of cancer being spread.

“We think, in general, the procedure should not be performed,” said 
the FDA’s William Maisel, adding that “there still may be individual 
patients who benefit.”

The FDA is outrightly recommending against laparoscopic morcellation 
in women with suspected or known uterine sarcoma.

Asked to comment, NEJM Journal Watch Women’s Health editor-in-chief 
Andrew Kaunitz said, “The current controversy … is focusing 
attention on tissue extraction alternatives, including manual or 
electronic morcellation within an endoscopic bag, as well as specimen 
removal either through laparoscopic-aided mini-laparotomy or through a 
vaginal incision. In addition, some hospitals have instituted policies 
on the use of electric morcellation during minimally invasive 
gynecologic surgeries.”

FDA MedWatch safety alert (Free)
By Kelly Young

Sildenafil, the most common drug prescribed for male impotence, with over $2 billion in annual sales, acts by inhibiting phosphodiesterase 5 (PDE5). BRAF mutations are associated with approximately 50% of melanomas, and recent studies show that the B-Raf 
protein also inhibits PDE5. To examine whether sildenafil increases 
risk for invasive melanoma, investigators accessed data on 25,848 
participants, 5.3% of whom had taken sildenafil within the previous 3 
months and 6.3% of whom had ever taken it. Those with previously 
diagnosed malignancies, including melanomas and nonmelanoma skin 
cancers, were excluded.

Between 2000 and 2010, 142 invasive melanomas were diagnosed in these 
participants. After multivariate-adjusted analysis controlling for 
family melanoma history, sun exposure, and ultraviolet index in the 
state of residence, melanomas were significantly more likely to have 
occurred in recent sildenafil users (hazard ratio, 1.84; confidence 
interval, 1.04-3.22) and sildenafil ever-users (HR, 1.92; CI, 
1.14-3.22). There was no association between sildenafil and cutaneous 
squamous cell carcinomas or basal cell carcinomas. Erectile 
dysfunction per se was not a risk factor — participants with erectile 
dysfunction but no sildenafil use had no increased risk.

Li W-Q et al. JAMA Intern Med 2014 Apr 7. Robinson JK. JAMA Intern Med 2014 Apr 7.
A complication to consider in treating erectile disfunction

Use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the elderly is 
associated with an increased risk for atrial fibrillation (AF), 
according to a prospective study in BMJ Open.

Using a Dutch cohort designed to investigate risk factors of disease 
onset in the aged, researchers followed some 8400 people for 13 years. 
None had AF at baseline (when their mean age was 69 years).

Current use of NSAIDs for 15 to 30 days was associated with a higher 
AF risk, relative to never use (adjusted hazard ratio, 1.76). Use in 
the recent past (within the past 30 days) also brought increased risk 
(HR 1.84). There was a suggestive dose-response relation, but it 
didn’t reach statistical significance.

The authors speculate that, in addition to possible effects on blood 
pressure, NSAIDs could cause fluctuations in serum potassium, possibly 
contributing to the observed association.

BMJ Open article