Two New Drug Risk Warnings from FDA

Estradiol Spray May Pose Risk for Kids and Pets - Menopausal women who use a spray form of topical estradiol (Evamist) to control hot flushes should avoid touching children and pets with treated areas of the skin, the FDA warned.

The agency said it had received eight reports of children ages 3 to 5 who showed breast enlargement and other signs of estrogen exposure after contact with women using the product.

Directions for use of the product -- approved in 2007 -- call for it to be sprayed onto the inside of the forearm.

"Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site," the FDA recommended.

Continue reading: Product Alert, Rx from MedPage Today: http://bit.ly/cgDlVj

FDA Finds Pneumonia Risk with Daptomycin - The FDA said that the intravenous antibiotic daptomycin (Cubicin) may be linked to an increased risk of eosinophilic pneumonia -- a rare but serious potential side effect -- and requested that a new drug label warning be added. 

The agency reviewed the medical literature and adverse event reports for daptomycin and identified seven cases of eosinophilic pneumonia between 2004 and 2010 "that were most likely associated with Cubicin" on the basis of six criteria, the agency indicated in a Drug Safety Communication.

"Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label," according to the statement.

In 2007, the daptomycin label was amended to include pulmonary eosinophilia as a potential adverse reaction.

Continue reading: Product Alert, Prescriptions from MedPage Today: http://bit.ly/a7JXoc

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Anti-psychotic drugs link to pneumonia

I have been warning against this for many years, but I also counsel on the effective use of vitamin A in high dose for short term use to prevent and correct pneumonia.

Nettle tea is also very helpful in the strengthening of the lungs.

Perhaps some of the readers of the Annals of Internal Medicine will take heed.

Anti-psychotic pneumonia warning
The use of anti-psychotic drugs in the elderly doubles the risk of potentially fatal pneumonia, say Dutch researchers.

A study of almost 2,000 patients found the increased risk starts soon after treatment begins and concluded that patients should be closely monitored.

An expert review published in 2009 found the drugs are overused in many cases and are responsible for up to 1,800 deaths in the UK every year.

Ministers have said they want to see a significant cut in their use.

The latest research published in the Annals of Internal Medicine compared the health records of 258 over-65s with pneumonia with 1,686 patients without the infection.

“ This paper yet again gives us evidence why we should not prescribe them unless absolutely necessary ” Professor Steve Field, Royal College of GPs

Of those with pneumonia, a quarter died within a month.

When they looked at prescribed drugs, they found current use of anti-psychotics was associated with a roughly two-fold increase in the risk of pneumonia.

Those on the newer types of anti-psychotic drugs were slightly less likely to have the infection than those on the older class of drugs but were still at significant increased risk.

The risk was found to start soon after treatment and increased the higher the dose of drugs the patient was prescribed.

Evidence

The researchers from Erasmus University Medical Center in Rotterdam said: "Clinicians who start treatment with anti-psychotic drugs should closely monitor patients, particularly at the start of therapy and if high doses are given."

Last year's UK review found that around 180,000 dementia patients a year are given the drugs in care homes, hospitals and their own homes to manage aggression but only around 36,000 would actually benefit from them.

Measures suggested in the report and accepted by the government included better monitoring of prescribing practices and ensuring that, where necessary, they were prescribed for short periods of time.

Professor Steve Field, chair of the Royal College of GPs said: "Anti-psychotics are prescribed too frequently without doctors thinking about the consequences.

"This paper yet again gives us evidence why we should not prescribe them unless absolutely necessary and if you do you should closely monitor the patient."

Story from BBC NEWS:http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/8599443.stm

Published: 2010/04/05 23:49:58 GMT, © BBC MMX

No Surprise: Pneumonia Vaccine does not protect against pneumonia

Pneumococcal Vaccine Does Not Appear To Protect Against Pneumonia

ScienceDaily (2009-01-07) -- Commonly used pneumococcal polysaccharide vaccines do not appear to be effective for preventing pneumonia, found a new study by a team of researchers from Switzerland and the United Kingdom. ... > read full article

Stopping Pneumonia

Inhaled Steroids Bring Greater Risk of Pneumonia

Steroid inhalers may raise pneumonia risks
Nov. 26, 2008

BALTIMORE, Nov. 26 (UPI) -- Steroid inhalers, commonly prescribed for people with pulmonary disease, can increase the risk of pneumonia, U.S. researchers said.

The Johns Hopkins University study also found that while inhalers helped, they did not extend a patient's life after a year of use, The Baltimore Sun reported Wednesday.

While medical experts have known for years that inhalers are effective in treating wheezing and breathlessness brought on by chronic obstructive pulmonary disease, doctors raised questions about steroid inhalers' side effects and whether they extended a patient's life, said the study's lead author, M. Bradley Drummond, a pulmonologist at the Johns Hopkins School of Medicine.

In the study, investigators examined 11 clinical trials, including 14,426 patients, comparing the incidence of pneumonia in those who used inhalers against those who did not.

Researchers said they weren't sure why inhalers increased the risk of pneumonia, but one theory is that they may weaken a person's immune system.

"Because these agents are so effective at controlling symptoms, we do feel there is a good role for inhaled steroids for treating COPD," Drummond said. "But for some patients there may be more harm than benefits."

Drummond said patients who use inhalers should not stop doing so, but talk with their physicians if they have concerns.

Common trade names for this class of drug in the US include Beclovent, Flovent, and Pulmicort, Aerobid and Azmacort.

For one example, using Flovent, also known generically as fluticasone, this is a fluoride based product. There would be an additive factor in that inhaler propellants have traditionally been fluoride based solutions (two chlorofluorocarbon propellants: trichlorofluoromethane and dichlorodifluoromethane).

People using these products should be closely monitored for respiratory function but adrenal insufficiency as well as immune and thyroid function and bone density.

It is not enough that the steroid use can impair immune and endocrine function but bone health as well, especially when the products have a higher than average percentage of fluoride compounds.

More likely than not the higher risk of pneumonia could be correlated with steroid induced immune suppression. Data show upper respiratory infection as a major side effect.

Calcium and DHEA may be depleted using these products also.

Inhaled steroids in the mouth promote Candida albicans(yeast)infections there and also disperse steroids throughout the body(absorbed via the mucous membrane).

Stopping Pneumonia

High quality probiotics do help many health issues, preventing secondary infection related to antibiotic use and ploy-antibiotic use of fluroquinolones, by maintaining health gut bacteria necessary for immune function. Other methods must be relied on when overuse of acid blockers reduces gastric HCl (hydrochloric acid). The acid acts to fight bacteria and help in protein digestion to give you the necessary nutrition to support your body while you're fighting off infection.

Another excellent way to fight pneumonia is the use of vitamin A. This can be by oral administration or in IVs for critically ill persons. The dose is very high for a short duration, either three days or seven days, with dose adjustment based on time used.

Vitamin A acts to protect the mucous membrane lining of the respiratory tract.

Probiotics 'may stop pneumonia'
Probiotics could be used to protect critically ill patients from developing pneumonia, according to scientists.

The friendly bacteria can block the colonisation by dangerous bugs of the airways of ventilated patients, the Swedish study concluded.

The probiotic solution performed just as well as normal antiseptics used to keep pneumonia-causing bacteria at bay, the journal Critical Care reported.

Being more natural it could pose fewer side effects, the authors said.

Friendly bugs

The probiotic bacterium Lactobacillus plantarum 299 is normally present in saliva and is also commonly found in fermented products like pickles and sauerkraut.

Although rare, some patients are allergic to the antiseptics normally used to prevent ventilator-associated pneumonia, namely chlorhexidine.

There is also a very small risk of the pneumonia-causing bacteria developing chlorhexidine resistance.

Pneumonia is a common complication in patients on breathing machines and occurs when harmful bacteria from the mouth, throat or breathing tube are inhaled into the lungs.

This is a plausible idea. But we need much larger trials that focus on clinical outcomes to prove it is an effective and affordable treatment
Bob Marsterton of the British Society for Antimicrobial Chemotherapy

Swabbing the mouth with chlorhexidine is widely recommended to reduce the risk ventilator-associated pneumonia in critically ill patients requiring mechanical ventilation.

Bengt Klarin and colleagues at the University Hospital in Lund, Sweden, compared the probiotic treatment with chlorhexidine in 50 critically ill patients.

Microbiological testing revealed both treatments appeared to be equally effective at preventing potentially harmful bacteria from flourishing in the mouth and throat.

In addition, a probiotic that adheres to mouth lining will be able to work around the clock, unlike antiseptics which wear off after a few hours, say the authors.

The scientists said bigger studies were now needed to investigate the feasibility of using probiotics in this setting.

Bob Marsterton, chair of the British Society for Antimicrobial Chemotherapy's working party on hospital acquired pneumonia, said: "This is a plausible idea. But we need much larger trials that focus on clinical outcomes to prove it is an effective and affordable treatment."

He said chlorhexidine highly effective, affordable and readily available.

Story from BBC NEWS:http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7708895.stm

Published: 2008/11/06 © BBC MMVIII