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 and Supplement Regulations

Updated 11/7/2015:

You might have been looking for these:

Death By Dietary Supplement (Forbes) - Lamar Odom, etc.

USP launches new GMP audit certification program

By Stephen DANIELLS, 03-Nov-2015
There’s a new player in the GMP audit sector, with the United States Pharmacopeial Convention (USP) expanding its verification services to include a new GMP audit program for dietary supplement and dietary ingredient manufacturers.

= = = original post below = = =

This Slate article is an interesting read about the proliferation of dietary supplements, and the interest in tighter regulatory oversight.

Herbal supplement dangers: FDA does not regulate supplements and they can be deadly. - Slate Magazine:

"Between 1994 and 2008, the number of dietary supplement products on the market increased from 4,000 to 75,000. In the first 10 months of 2008, the FDA received nearly 600 reports of serious adverse events (including hospitalization, disability, and death) from these products and 350 reports of moderate or mild adverse events. However, the FDA believes that these reports are drastically underreported and estimates that the annual number of all adverse events is 50,000."

'via Blog this'

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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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Medical device software criticized as under-regulated - latimes.com

Image via WikipediaMedical device software criticized as under-regulated - latimes.com:  'via Blog this'

In a nutshell:

"Between 1983 and 1997, 1 in 4 medical devices used software. Today, the figure is more than half. Software problems are now the third-leading cause for recalls of medical devices."

Just when you thought technology might move us ahead.

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If You're Anti-Vaccination - Then Risk Deafness, Blindness, Brain Damage or Seizures

How quickly we forget.

According to this Susan Reimer Baltimore Sun article, Vaccine refusal -- you call this cautious?:

"Childhood immunizations are victims of their own success"

Consider erring on the side of caution.

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FDA Proposes Electronic Safety Reporting

The FDA states in their news release, FDA Proposes Mandatory Electronic Safety Reporting - New Rules will Help Strengthen Postmarket Safety Data Collection, that they've issued two proposed rules — one that applies to electronic medical device adverse event reporting, and one that applies to electronic drug and biologic product adverse experience reporting. The proposed rules would not change what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review, and archive. Additional Information From the FDA:

• FDA’s Web site on Electronic Medical Device Reporting: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
• FDA’s Web site on the FDA eSubmitter: http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
• Fact Sheet: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm179586.htm

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Fewer FDA Inspectors - More Device Complaints

Here's an excellent graphic crafted by Dan Nguyen and Christina Jewett, Graphic: At FDA, Fewer Inspectors Trace More Device Complaints. It's easy to understand that from 1997 through 2007, two major trends have emerged: 1) adverse event reports have risen dramatically over the years, and 2) the number of FDA FTEs in the medical device field division have steadily declined. What you have to do, to shock some reality into yourself, is to view their graphic. Go see it. 

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FDA Website Redesigned

The FDA reports that "Through collaboration with users in testing site-wide designs, we made improvements to make FDA.gov easier and more satisfying to use." That may well be true as they describe their thinking on the redesign, About the FDA.gov Redesign - Why did FDA change its Website? Unfortunately, one unintended adverse effect impacts this blog. So, my apologies to folks who use and follow this blog . . . The FDA redesign has broken many links to FDA images, documents, and webpages. Here's to hoping they won't be redesigning the site again, any time soon. Peace.

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FDA - Transdermal Patches - MRI Burning Risk (Podcast)

A quick re-reminder that not all transdermal patches come with labelling warning patients about the burning risk while undergoing an MRI exam. Listen to this FDA Podcast, Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings, or read the transcript "Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings." 

Related Posts: FDA Warns - Avoid Burning - MRI and Drug Patch Interaction Duck - It Is A Sandbag - Flying In The MRI Room Are You Safe In An MRI Machine? 

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FDA Warns - Avoid Burning - MRI and Drug Patch Interaction

Updated November 22, 2022

The original links broke.

You can still read about the same topic here:

• FDA advisory: Transdermal drug patches with metallic backings may cause burns during MRI - Healio
• What Patients Should Know Before Having an MRI Exam - FDA.gov

---  the original post follows below  ---

If you wear drug patches, watch out! You don't want to get burned. If you wear them into an MRI machine, the patch could burn you, warns the FDA in their alert, FDA Warns About Risk of Wearing Medicated Patches During MRIs.

FDA recommends that patients who use medicated patches (including nicotine patches) do the following:

• Tell the doctor referring you for an MRI scan that you are using a patch and why you are using it (such as, for pain, smoking cessation, hormones)
• Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.
• Tell the MRI facility that you are using a patch. You should do this when making your appointment and during the health history questions you are asked when you arrive for your appointment.

Additional Info by the FDA & others: FDA Public Health Advisory Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Transdermal Drug Patches with Metallic Backings Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009 

Related Posts: Are You Safe In An MRI Machine? 

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FDA Reports Latest List of Potentially Risky Drugs

The FDA has just released its quarterly Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008. The FDA has identified potential safety issues, but this does not mean that FDA has identified a causal relationship between the drug and the listed risk. I've listed the July - Sept '08 list of affected drugs here . . . Product Name: Active Ingredient (Trade) or Product Class (Potential Signal of Serious Risk/New Safety Information)

1. Codeine-containing cough medicine (Adverse events in children)
2. Oral bisphosphonates (Esophageal cancer)
3. Mefloquine HCl (Lariam)(Psychiatric events)
4. Minocycline (Thyroid disorders)
5. Bupivicaine intraarticular injection given by infusion pump (Chondrolysis)
6. Selective serotonin and selective norepinephrine reuptake Inhibitors (SSRI and SNRI) antidepressants (Birth defects)
7. Propylthiouracil and Methimazole (Hepatotoxicity)
8. Phenytoin injection (Cardiac arrest due to rapid injectionK)
9. Terbinafine (Lamisil) oral use (Psychiatric events)

For more complete FDA information: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) Quarterly Reports 2008 January to March 2008 April to June 2008 July to September

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FDA and SAEC Release First Data on Genetic Basis of ADEs

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Updated July 1, 2025

The original links broke.

You can still read about the same topic here:

FDA And International Serious Adverse Events Consortium Release First Data On Genetic Basis Of Adverse Drug Events - Pharmaceutical Online

---  the original post follows below  ---

The FDA just announced, FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events. The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions. “We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC. This is a pretty exciting example of how to apply genomics to research the genetic basis of serious adverse events. 

Additional Information: 

• For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org. 
• For information on the FDA’s Critical Path Initiative see
  https://www.fda.gov/science-research/science-and-research-special-topics/critical-path-initiative

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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

---  the original post follows below  ---

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

The original link broke.

You can still read about the same topic here:

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

---  the original post follows below  ---

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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20 Drugs - New FDA Safety Info

The FDA began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). Here are the results of their very first quarterly report, Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): January - March 2008.

The FDA list is a bare-bones compilation naming 20 medications and the potential issue for each. This Reuter's news article provides a little more information about the 20 drugs, and is a little easier to digest, "FACTBOX: Drugs on U.S. FDA list for possible risks."

Bottomline
As stated in the FDA news release, "My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research."

Additional Information Sources

1. FDA to Post Quarterly Report of Potential Safety Issues (news release)
2. Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) - links to quarterly reports

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

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Updated March 19, 2022

The original link broke.

You can still read about the same topic here:

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

---  the original post follows below  ---

 

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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