The MedWatch October 2011 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” available via the following link provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm279222.htm
Clicking on a drug product name in the Summary View available via the above link will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
- Definity Vial for (Perflutren
- Lipid Microsphere) Injectable Suspension
- Evamist (estradiol transdermal spray)
- Selzentry (maraviroc) Tablets
- Demerol (meperidine hydrochloride)
- Oral Hycamtin (topotecan) Capsules
- Premarin (conjugated estrogens tablets, USP)
- Suprenza (phentermine hydrochloride) ODT
- Amturnide (amlodipine/aliskiren/hydrochlorothiazide) Tablets
- Avelox (moxifloxacin hydrochloride) Tablets and IV
- Byetta (exenatide) injection
- Clozaril (clozapine) Tablets
- Ciprofloxacin Tablets
- Ciprofloxacin IV for Inusion Vial
- Ciprofloxacin 0.2 % Solution in 5% Dextrose
- Ciprofloxacin Oral Suspension
- Cipro XR Tablets
- Factive (gemifloxacin mesylate) Tablets
- Gallium Citrate Ga 67 Injection
- Lactated Ringer’s injection in aviva plastic container
- Lactated Ringer’s
- Lactated Ringer’s and 5% Dextrose
- Sodium Lactate (M/6 sodium lactate) injections in viaflex plastic container
- Levaquin (levofloxacin) Tablets
- Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules
- Lithobid (lithium carbonate) Extended-Release tablets
- Nexavar (sorafenib)
- Noroxin (norfloxacin) Tablets
- OxyContin (oxycodone hydrochloride) Controlled-Release Tablets
- Tasigna (nilotinib) Capsules
- Veramyst, (fluticasone furoate) Nasal Spray
- Votrient (pazopanib hydrochloride) Tablets
- Vumon (teniposide) Injection
- Vytorin (ezetimibe/simvastatin) Tablets
- Zocor (simvastatin) Tablets
Remember, never take any medication that you do not really need. If necessary, seek a second opinion. Regularl have your prescription medication use reviewed.
Tags: MedWatch
On Thursday November 17 the Royal National Orthopaedic Hospital in London, England is hosting a conference on Vitamin D. You can obtain further details and download a leaflet here: http://www.rnoh.nhs.uk/health-professionals/courses-conferences/vitamin-d-conference .
Hear from international experts including Professor Vieth who has studied and lectured about Vitamin D for more than 20 years. Professor Bishop from Sheffield is the only UK professor of children’s medical bone disease. A range of other London experts will explain the impact of Vitamin D deficiency in babies, children and adults – with practical guidance on how to prevent many of the problems.
Learn about current policy regarding who should have blood levels checked, who should have supplements, and whether these should be prescribed by doctors or other health professionals. Understand the recommendations for Vitamin D dosage and duration of treatment in cases of deficiency and gain knowledge of the blood levels which indicate insufficiency or deficiency.
Hear about research on the role that Vitamin D plays in many illnesses such as gestational diabetes, plus toxicity and safe blood levels. Share your knowledge and clinical experiences by participating in an open discussion about new treatment guidelines and protocols.
The Royal National Orthopaedic Hospital treats patients from across the UK, so doctors, health visitors, midwives, pharmacists, public health and other health professionals from far and wide will be attending.
The meeting is sponsored by an unrestricted educational grant from Cow & Gate.
To book a place, please use the online booking form at www.rnoh.nhs.uk/courses Registration fee (inclusive of food, refreshments and a PDF copy of the presentation) is as follows:
Doctors – £50. Nurses, Midwives, Allied Health Professionals and Pharmacists – £15.
For further information, please contact the Teaching Centre in London on 020 8909 5326, or email courses@rnoh.nhs.uk
Tags: Vitamin D conference
I am taking the unusual step of placing a link to a website that urges citizens of the United States to take a small but important action related to your government’s fiscal responsibility. The website provides an informative auido and video presentation. It explains the financial situation faced by Americans due to the debt burden incurred by successive governmnents. It is factual and, I hope motivating, but it is not hype ridden or emotional. The purpose of the presentation is to encourage you to sign a petition that urges action on the debt situation.
Why am I doing this? What has it to do with health? Fair questions, allow me to very briefly answer them.
Why am I doing this? Essentially because I believe it is an extremely important issue. The global financial situation has become precarious and very few, if any, effective solutions are being implemented by governments. We seem to have politicians everywhere who are weak, self-interested and short-sighted. Left to their own devices they will almost certainly fail to avert extremely serous problems. One can only hope that politicians and their advisors will still listen to the massed voices of ordinary citizens who bother to speak up and insist they be heard. A petition is a time-honoured way to do this.
What has it to do with health? Everything. The seriousness of the situation is such that the world as we know it could be at risk. Massive financial instability and collapse will dramatically undermine health and wellbeing at every level. International and national health systems (such as they are) could completely fail. Associated high levels of sustained stress due to the outworking and outcomes of such financial problems will also seriously undermine the health of individuals and wellbeing of families.
The petition is for Americans and relates to the financial mess in America. However, this is an issue that concerns all global citizens. The United States is still the largest economy in the world and its currency remains the global reserve currency. The problems and risks facing the American economy and people therefore can quickly become problems and risks for the whole world.
Find the presentation here: http://www.5minutedebtpetition.com/ I encourage you to consider the presentation and hope you will sign the petition.
Tags: debt destroys health
Telomeres are regions at the end of a chromosome, which protect the end of it from deterioration, the longer the better. The telomere regions reduce the degradation of genes near the ends of chromosomes by allowing for the shortening of chromosome ends, which necessarily occurs during chromosome replication. Over time, due to numerous cell divisions over your lifetime, the telomeres become shorter.
During cell division, if cells divide without telomeres, they would lose the ends of their chromosomes and the necessary information they contain. The telomeres are disposable buffers blocking the ends of the chromosomes; they are consumed during cell division, but then replenished by an enzyme, telomerase.
Telomerase deficiency is associated with aging, death, obesity, cardiovascular disease, depression and diabetes.
Telomerase deficiency is associated with aging, death, obesity, cardiovascular disease, depression and diabetes. In October, scientists at the Georgia Health Sciences University, led by Dr. Zhu, reported on the effect of vitamin D on telomerase activity in obese African Americans. They gave 60,000 IU per month for four months to one group and placebo to another group.
The authors found that vitamin D increased telomerase activity by 19%. The authors wrote, “Our data suggest that vitamin D may improve telomere maintenance and prevent cell senescence.”
That is, vitamin D is the repair and maintenance man of the human body. When you think about it, of all the things vitamin D does, it usually works by repairing and maintaining the human body.
One thing I didn’t understand about their study was the dose response. They gave 60,000 IU per month (about 2,000 IU/day) but reported that vitamin D levels increased from 16 to 40 ng/ml and this was a study of obese subjects. I emailed the author, and he said they drew the last blood work, 25-30 days after the last dose of vitamin D. The vitamin D levels were higher than I would have expected.
I am leery of studies that use monthly doses, although this one showed an important positive effect. Primitive man didn’t get sunshine one day a month and vitamin D levels fall the last two weeks after a monthly 60,000 IU dose, perhaps activating the enzyme that destroys activated vitamin D in the cells. I also wonder what the effect would have been if the subjects all took 2,000 IU/day (the equivalent of 60,000 IU/month). I don’t know but predict it would have been more than a 19% increase in telomerase.
From Vitamin D Council Newsletter
Dr John Cannell
Tags: telomerase activity, vitamin D
FDA notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient’s risk of having a heart attack or stroke. FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The ACCORD Lipid trial found no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone.
Information from the trial has been added to the Important Limitations of Use and Warnings and Precautions sections of the Trilipix physician label and to the patient Medication Guide.
BACKGROUND: Trilipix (fenofibric acid) was approved by FDA in 2008 to treat cholesterol in the blood by lowering the total amount of triglycerides and low-density lipoprotein (LDL) cholesterol, and increasing the high-density lipoprotein (HDL) cholesterol.
RECOMMENDATION: Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in patients in two large randomized controlled trials of patients with type 2 diabetes mellitus; healthcare professionals should consider the benefits and risks of Trilipix when deciding to prescribe the drug to patients, and counsel patients about those benefits and risks.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Why accept the risks associated with this drug for no benefit at all? Save money and you may help save your life – avoid this drug.