FDA grants “fast track” designation to pneumonia drug

By Dr Deepu

FDA grants “fast track” designation to pneumonia drug

The Triangle (NC) Business Journal (8/19, deBruyn, Subscription Publication) reports that Chapel Hill-based drug developer Cempra Inc. received “Fast Track” designation from the FDA to expedite the review process for “Cempra’s experimental drug solithromycin, a treatment for community acquired bacterial pneumonia (CABP).” The drug is “currently in Phase 3 development for the treatment of CABP and Cempra plans a New Drug Application submission in 2016.”

Combined use of antidepressants and painkillers linked to bleeding risk

Extra vigilance needed when using both types of drugs together

Taking a combination of antidepressants and common painkillers is associated with an increased risk of bleeding soon after starting treatment, finds a study published in The BMJ this week.

The researchers say their results may have been affected by other unmeasured or unknown factors and should be interpreted with caution. However, they suggest special attention is needed when patients use both these classes of drugs together.

Depression produces the greatest decrement in health of all common chronic conditions and depression in older people is an important public health problem.

But concern exists that antidepressants may interact with common painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) to increase the risk of bleeding inside the skull (intracranial haemorrhage).

So a team of researchers based in Korea compared the risk of bleeding among patients treated with antidepressants with and without NSAIDs.

Using the Korean nationwide health insurance database, their study involved over four million people who were prescribed antidepressants for the first time between 2009 and 2013.

NSAID prescriptions were obtained and hospital records were used to identify time to first admission with intracranial haemorrhage within 30 days of a new prescription. Factors that could affect the results, such as age, sex, and use of other medications, were taken into account.

Compared with use of antidepressants alone, the team found that combined use of antidepressants and NSAIDs was associated with a substantially increased bleeding risk.

They found no statistically meaningful differences in risk of bleeding between different types of antidepressant drugs, or with age. Being male was the most common factor for a higher risk of bleeding with combined use of antidepressants and NSAIDs.

"The addition of NSAIDs to antidepressant treatment increased the risk of intracranial haemorrhage within 30 days of the combination starting, especially in men," conclude the authors. "This result adds to evidence confirming the increase of risk with combination use of antidepressants and NSAIDs."

In an accompanying editorial, Dr Stewart Mercer at the University of Glasgow and colleagues at the University of Cambridge, say the results give some cause for concern.

They point out that both types of drug are widely used, and that co-morbidity of the conditions for which these drugs are used is very high - 65% of those with major depression also have chronic pain.

They urge family doctors to be extra vigilant in terms of prescribing behaviour and discussing the risks with patients, especially in deprived areas where "the combination of mental and physical problems (including chronic pain) is very common." And they say further research is required to extend the findings over longer time periods and in differing populations.

Link to full

High-Flow Nasal Therapy Effective As NIV In Preterm Infants

Medscape (8/18) reports that an analysis published in the journal Pediatrics found that high-flow nasal cannula therapy “is as safe and efficacious as conventional modes of noninvasive ventilation (NIV) in preterm infants.” The study, which compared high-flow therapy with nasal continuous positive airway pressure, found “no significant differences between groups with respect to a variety of secondary outcomes,” such as the duration of time in the neonatal unit or respiratory support.

COPD Patients With Comorbid Mental Issue Have Higher Readmission Risk

According to Lung Disease News (8/18, Semedo), a recent study in the journal CHEST found that psychological conditions such as depression anxiety, or psychosis were associated with a higher risk of hospital readmission for COPD complications. “These psychological disorders are more likely to predict early readmission than other significant factors,” said Gurinder Singh of the University of Texas Medical Branch at Galveston. “This is likely related to the limited ability of these patients to handle the COPD, poor social support or community resources and non-adherence with treatment,” Singh added.

E-Cigarettes Not Gateway Drug Among British Youth, Survey Says

The Guardian (UK) (8/17, Meikle) reports that an online survey by the British anti-tobacco group Action On Smoking and Health found that “experimentation with e-cigarettes is rising among 11- to 18-year-olds in Britain but is most common among those who already smoke or who have done in the past.” The group suggests that the results show it is “unlikely” that e-cigarettes are being used as a gateway drug to tobacco. Also covering the story are the Daily Mail (UK) (8/17, Duell) and the Independent (UK). (8/17, Connor)

Helicobacter Pylori May Be Common In Patients With COPD

The Daily Mail (UK) (8/16) reported that “the bacteria helicobacter pylori” may “be common in patients with chronic obstructive pulmonary disease (COPD).” Research has “found that levels of the bacteria are up to three times higher in people with COPD, and one theory is that infection in childhood may affect the growth of the lungs, making them more vulnerable to disease.”

Researcher Identify Factors That May Put COPD Patients At Higher Risk For Falls

Reuters (8/15, Rapaport) reported that research suggests that older individuals with COPD may have a higher likelihood of experiencing falls if they have additional medical conditions, prior falls, or a lengthier smoking history. The findings were published in Respirology.