Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business

Read the full article: Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business:

"FDA spokesman Chris Kelly called the meeting an introduction and a chance "for the agency to begin a discussion on how we might collaborate with Google on identifying adverse event data, using Google’s technologies and data.”"

'via Blog this'

#FDA #GMP #training #cGMP

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FDA withdraws approval of drug Avastin to treat breast cancer

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FDA withdraws approval of drug Avastin to treat breast cancer - latimes.com:

"Studies showed that women with advanced breast cancer taking Avastin had a higher risk of death from stroke or heart attack, and that the medication raised blood pressure and increased the risk of congestive heart failure. The risk of serious bleeding was five times higher among users of Avastin than it was for those on chemotherapy only."  'via Blog this'

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FDA Warning On Weight Loss Products

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Updated December 28, 2021

The links in the original post broke.

You might also be interested in:

Tainted Weight Loss Products - FDA.gov

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No doubt we'll have overeaten on Christmas, and we'll continue to do so through the holidays. Then in the new year, we'll all be tempted to lose some weight. We'll schedule workouts at the gym, go on diets, and start taking weight loss products. But stop and read before you take those weight loss products, warns the FDA, as reported in a recent American Society of Health-System Pharmacists (ASHP) daily news briefing. In general, the FDA "has listed more than 25 weight loss products to avoid, because they contain ingredients that are not labeled, and could cause serious health problems." Some of the ingredients illegally contain drugs that should be sold by prescription only. The news briefing suggests the following links for further reading . . . Are you planning to take weight loss pills? 

Bloomberg News - Illegal Weight Loss Pills May Cause Heart Attacks 

FDA News - FDA Warns Consumers About Tainted Weight Loss Pills 

AP News - FDA warns against some diet pills sold on the Web 

HealthDay - FDA Warns About Weight Loss Products 

Chicago Tribune - FDA warnings for 30 diet drugs 

WebMD - FDA Warns of Risky Weight Loss Pills 

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Testing Approved Drugs In The Real World With Real People

Updated November 25, 2022

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New Arena for Testing of Drugs: Real World - TuscaloosaNews.com

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In the drug development process, drugs are clinically tested in very select patient populations. This means that once a drug gets approved, the drug is often given to quite a different kind of patient population, and the results of drug treatment could be different. For the big picture, read this compelling Star News Online article, "New Arena for Testing of Drugs: Real World." I find the story so compelling for the following reasons . . .

1. Patients, health care professionals, and the pharmaceutical industry bring their own unique health and business issues or needs to the table
2. It's ultimately about the patient, and there's a need to know whether approved drugs help or harm in the real world

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Ouch! Black Box, Black Eye. Watch Out For These Antibotics.

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Updated March 19, 2022

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FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects - FDA.gov

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Increased risk of tendinitis and tendon rupture - It's tough to be a drug company, and it's tough to be a patient taking medications. The FDA just released this alert, Information for Health Professionals - Fluoroquinolone Antimicrobial Drugs. So, if you're taking any of the following: Cipro, Proquin, Factive, Levaquin, Avelox, Noroxin, Floxin, or their myriad generically named brethren, then you should read the FDA release. This class of drugs just earned a black box warning, which means patients and prescribers should pay more attention to this unwanted effect. It's worth repeating the main thrust of the alert, "Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug." 

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