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Monday, September 17, 2018

Blood Pressure medicine recalled due to contamination from Chinese source


Known as HCTZ Valsartan, or under other names by various generic manufacturers, the FDA and other drug watchdogs in Europe and Canada have reported that the Chinese pharmaceutical company making the raw materials are shipping contaminated drugs containing one or even two kinds of carcinogens.

FDA UPDATE https://www.fda.gov/drugs/drugsafety/ucm613916.htm

Here are links to the recalled drugs and also a list of those not recalled.

NOT recalled https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615704.pdf

Under recall https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf

Teva
Acativas (Teva)
AvKARE also Teva
Princeton/Solco and RemedyPrepack
AS Medication another Teva and Solco
BRYANT another Teva
 HJ Harkins another Solco Princeton
Northwind
NuCare
Preferred
Torrent






Sunday, September 16, 2018

Background - More Aspirin Studies Early Study Inconclusive

See next blog posting for the new studies, this is background.

As with many medical studies the results of studies on men and women and low dose aspirin are confusing and sometimes contradictory but remember that the newest studies published in peer-reviewed journals such as the NEJM or The Lancet, Nature, and Science, are built on the information obtained from the earlier studies and are therefore likely to be correct even when they contradict the older studies.

Studies of the results for women and girls are especially important because until recently most studies were conducted on men and only in recent years has it been shown that the results for women can vary greatly from those for men. That one chromosome is very important.

A randomized trial published in the NEJM in 2005 found only a tiny, 9% improvement in preventing initial heart attacks in women so the new studies should be considered especially important for women when considering the proven risks vs the small potential benefits of low dose aspirin therapy.

https://www.nejm.org/doi/full/10.1056/NEJMoa050613

Quoted from NEJM:

"BACKGROUND

Randomized trials have shown that low-dose aspirin decreases the risk of a first myocardial infarction in men, with little effect on the risk of ischemic stroke. There are few similar data in women.

METHODS

We randomly assigned 39,876 initially healthy women 45 years of age or older to receive 100 mg of aspirin on alternate days or placebo and then monitored them for 10 years for a first major cardiovascular event (i.e., nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes)."

and
"Although aspirin is effective in the treatment of acute myocardial infarction and in the secondary prevention of cardiovascular disease among both men and women,1 its use in primary prevention remains controversial. To date, five randomized trials involving 55,580 participants have evaluated aspirin in the primary prevention of cardiovascular disease.2-6 In aggregate, these trials indicate that, as compared with placebo, aspirin therapy was associated with a significant, 32 percent reduction in the risk of myocardial infarction, but the data on the risk of stroke and death from cardiovascular disease remains inconclusive.7Moreover, three of these trials evaluated men exclusively, and fewer than 180 of the 2402 vascular events occurred in women. Thus, at this time, the current recommendations for the use of aspirin in primary prevention in women are based on limited direct data from women" 

Low Dose Aspirin Not Helpful and Actually Dangerous say 3 NEJM published studies

Taking a low dose aspirin has been considered the standard of good health practice for decades to prevent the first heart attack in otherwise healthy people.

Unfortunately this common medical wisdom isn't actually supported by a lot of evidence and now the New England Journal of Medicine has published three studies with more than 20,000 participants showing that not only is this not a good way for people over 65 (and probably younger) to prevent a first heart attack.

Also, because aspirin, even low dose or "baby" aspirin (between about 80 mg and 300 mg) reduces the ability for blood to clot it can encourage bleeding in the brain.


Effect of Aspirin on Disability-free Survival in the Healthy Elderly  
J.J. McNeil and Others   
<http://response.nejm.org/t?ctl=45B57:82F864202E91A81197A27C9082BFE7BDF91BDD2A20A1D99A&uuid=10295107&dateTime=201809260000&key=wZxk%2FaDT8hj7YLGnnkqQUfeBvC5O%2Br%2FO5gm4%2FvQeP%2Fw%3D>   
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ORIGINAL ARTICLE

Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly  
J.J. McNeil and Others   
<http://response.nejm.org/t?ctl=45B58:82F864202E91A81197A27C9082BFE7BDF91BDD2A20A1D99A&uuid=10295107&dateTime=201809260000&key=wZxk%2FaDT8hj7YLGnnkqQUfeBvC5O%2Br%2FO5gm4%2FvQeP%2Fw%3D>   
Free Full Text

ORIGINAL ARTICLE

Effect of Aspirin on All-Cause Mortality in the Healthy Elderly  
J.J. McNeil and Others   
<http://response.nejm.org/t?ctl=45B59:82F864202E91A81197A27C9082BFE7BDF91BDD2A20A1D99A&uuid=10295107&dateTime=201809260000&key=wZxk%2FaDT8hj7YLGnnkqQUfeBvC5O%2Br%2FO5gm4%2FvQeP%2Fw%3D>   
Free Full Text