The MedWatch September 2011 Safety Labeling Changes posting includes 34 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/ucm274280.htm
Clicking on a drug product name in the Summary View 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:
- Detrol (tolterodine tartrate) tablets and Detrol LA (tolterodine tartrate) extended release tablets
- Orap (pimozide) 1 mg and 2 mg tablets
- Anzemet (dolasetron mesylate) tablets and Anzemet (dolasetron mesylate) injection
- Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
- Avastin (bevacizumab)
- Cymbalta (duloxetine hydrochloride)
- Effient (prasugrel hydrochloride) 5 mg and 10 mg Tablets
- Ellence (epirubicin hydrochloride) injection
- Istodax (romidepsin) for Injection
- Lexiscan (regadenoson) Injection
- MultiHance (gadobenate dimeglumine) injection
- Nicorette (nicotine polacrilex) 2 mg and 4mg gum [OTC]
- Procardia (nifedipine) 10 mg Capsules
- Procardia XL (nifedipine) 30 mg, 60 mg, and 90 mg Extended Release Capsules
- Stimate (desmopressin acetate) 1.5 mg/mL nasal spray
- Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension for intramuscular use
- Risperdal (risperidone) tablets, oral solution
- Risperdal M-Tab (risperidone) orally disintegrating tablets
- Risperdal Consta (risperidone) long-acting injection
- Xenon Xe 133 Gas, 10 and 20 mCi, septum sealed glass vial
- Zofran (ondansetron hydrochloride) injection and premixed injection
- Zofran (ondansetron hydrochloride) tablets, oral solution, and orally disintegrating tablets
Remember, never take any drugs unless they are absolutely necessary All drugs pose some danger.
Tags: FDA safety label changes, MedWatch
Official research described in the Morbidity and Mortality Weekly Report August 19, 2011 / 60(32);1073-1077 shows almost 40 percent of health care personnel rejected influenza vaccination in the 2009-2010 influenza season in the United States. Despite significant pressure and high availability only 61.9% of health care professionals received the seasonal influenza vaccination.
The Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee recommend that all U.S. health-care personnel (HCP) be vaccinated annually against influenza. However, even among HCP who reported working at a facility where vaccination was required by their employer, only 98.1% were vaccinated.
According to an editorial note “when compared with those vaccinated, significantly lower percentages of unvaccinated HCP expressed the beliefs that getting vaccinated was worth the time and expense and that influenza vaccination can protect them and the persons around them from disease.”
One has to ask the question, if nearly 40% of health workers reject influenza vaccination and a significant number of those do not believe influenza vaccination to be effective, why should ordinary consumers take on the risks associated with vaccination?
Full details are available here: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6032a1.htm?s_cid=mm6032a1_e&source=govdelivery
Tags: reject vaccination, vaccination
Think of a study of more than 81,000 women. How much time do you think such a study would take; how much effort from the scientists? Then say it was prospective, that is, it looked into the future from the past. Dr. Elizabeth Bertone-Johnson, from the University of Massachusetts, senior author JoAnn Manson, from Harvard, and 12 colleagues from the Women’s Health Initiative did just that in a paper published in October of 2011. They looked at vitamin D intake from foods and supplements and current and later symptoms of depression.
The authors begin,
“Vitamin D may affect the function of dopamine and norepinephrine, which are monoamine neurotransmitters that are likely involved in depression. Furthermore, vitamin D may modulate the relation between depression and inflammation.”
They assessed 81,000 women at baseline (1993 -1998) and 3 years later for depression, using a simple depression rating scale, and for total vitamin D intake from foods and supplements. Their finding:
“In cross-sectional analysis that used baseline data, women with the highest intake of vitamin D and vitamin D from food sources had a significantly lower prevalence of depressive symptoms. . . In women without depressive symptoms at baseline, a higher vitamin D intake from food as associated with a lower risk of depression at year 3.”
However, they added,
“We did not find supplemental vitamin D intakes to be consistently related to measures of depressive symptoms.”
Explaining that in their group of women, for surprising and unknown reasons, vitamin D levels were higher in women who did not use vitamin D supplements. Remember in 1998, vitamin D supplements were either cod liver oil or multivitamins, both of which contained little vitamin D and toxic amounts of preformed retinol in the 1990s.
They went on to quote studies indicating that not 90%, but only 30% of vitamin D currently comes from sunlight. “Recent evidence suggested that only ~30% of circulating 25(OH)D is the product of sunlight exposure.” The studies indicating 90% comes from sunlight expose were from the early 1980s, when 90% did come from sunlight. This change from 90% to 30% reflects just how much we have become sunless creatures. Nature must have been totally surprised, when one day in the late 1980s, we suddenly decided that the Nature’s gift of sunlight was evil.
The authors conclude,
“Our results support an inverse association of vitamin D intake from foods and the occurrence of depressive symptoms in older women.”
In other words, this means the higher vitamin D intake from food the less depression. This is a good reason to eat ocean-caught salmon and fresh tuna (also known as brain food) two or three time a week.
The following is an important article by Dr John Cannell of the Vitamin D Council.
In September, 2011, two papers with three case reports of vitamin D toxicity were published. Two cases were manufacturing errors and one was a pharmacist’s mistake. Vitamin D levels associated with clear toxicity ranged from 194 to 1220 ng/ml. To my knowledge, toxicity occurring at 194 ng/ml is the lowest vitamin D level causing clear toxicity known in the medical literature.
In the first case, a pharmacist’s dispensing error occurred when the doctor wrote a prescription for 1,000 IU/day of D3. Since it was not a prescription item, the pharmacist thought the doctor meant prescription Drisdol, which is 50,000 IU. So the patient, a 70-year old woman with mild dementia, began taking 50,000 IU/day of D2. She was also taking, for reasons unknown, 3100 mg of calcium per day.
Three months later she developed confusion, slurred speech, unstable gait, and increased fatigue. Probably due to her dementia, she did not complain of the most common symptoms of toxicity: lack of appetite, excessive thirst, nausea, abdominal pain and increased urination. Her vitamin D level was 194 ng/ml, her calcium (CA) was 14.6 (8.5-10.5 is normal); her kidney function was impaired with a creatinine of 5.3 (CR); her activated vitamin D level was normal, her urine CA/CR ratio was elevated, but she had no anemia. All vitamin D and calcium was withheld and her doctors treated her with IV fluids. Four days later her symptoms disappeared and her calcium returned to normal and her creatinine improved to 3.0. Five months later her vitamin D level was 40, her calcium was 9.2, and her creatinine was back at baseline, 1.8.
To my knowledge, this is the first modern case report of toxicity at 50,000 IU/day (and this was D2), although this case also included 3100 mg/day of calcium. Unfortunately, I have heard that a few physicians use 50,000 IU/day routinely. It is too much, way too much. However, this lady completely recovered with no damage to her kidneys.
Secondly, why would anyone take 3100 mg/day of calcium? In this case she was demented. However, many people believe that the government recommendation of 1200 mg/day of calcium for females over the age of 50 means they should literally take 1200 mg/day as a supplement. It does not mean that at all. It means total dietary and supplement intake should be 1200 mg/day and everyone gets some calcium in their diet. Most people need no more than 500 mg/day of calcium as a supplement and many people who eat dairy three times a day need none.
The other two cases were equally interesting, but involved manufacturing errors. It is one of the reasons I recommend you get your vitamin D from one of our sponsors, Stop Aging Now or Bio-Tech-Pharmacal (links on the right). Both companies are experienced and careful in their vitamin D manufacturing process.
In case two, an otherwise healthy man developed fatigue, excessive thirst, frequent urination and confusion. Three weeks later he was admitted to hospital in a coma with a vitamin D level of 1220 ng/ml (24 times that of a healthy level), calcium of 15, activated vitamin D of 106, massive calcium loss in the urine, mild anemia, and elevated urine CA/CR ratio. He had been taking “Formula F,” labeled to contain 1600 IU of vitamin D but it really contained 186,400 IU per capsule. In addition, “Formula F’s” label recommended 10 capsules per day, not one, so the patient had been taking 1,864,000 IU daily for two months! After treatment, calcium returned to normal in three weeks; the vitamin D level and the creatinine returned to normal in a year. That is, he completely recovered.
Case three (in the above paper) was a 40-year old man who presented with excessive thirst, frequent urination, muscle aches, nausea, vomiting, elevated calcium (13.2), elevated creatinine (1.78), vitamin D level of 645 ng/ml, elevated activated vitamin D of 99, mild anemia, and an elevated urine Ca/Cr ratio. He reported taking “Gary Null’s Ultimate Power Meal” for a month, which mistakenly contained 970,000 IU of vitamin D per serving. Calcium returned to normal in several days, kidney function returned to normal in 4 weeks, vitamin D level normalized in 10 months but activated vitamin D took a year to normalize. No permanent injuries occurred, much to the chagrin of the trial lawyers.
The takeaway from these three papers is that if you take more than 10,000 IU/day, you must check your 25(OH)D regularly. I am concerned that people with levels greater than 150 ng/ml may be urinating out more calcium than they should; that is urinating out their bones. A 1988 paper suggested exactly that and I have clinic experience that shows in at least one person, a 24 hour urine calcium was elevated before the urine Ca/Cr ratio was abnormal. To be safe, keep your 25(OH)D vitamin D levels below 100 ng/ml.
Tags: vitamin D, vitamin D toxicity
The October edition of The Health Gazette Ezine will be published as scheduled on October 1st.
In October we continue our ongoing series on The Dimensions of Health. The focus will be on the spiritual dimension of health.
Subscribers will find the ezine in their mailbox first and in the archive shortly thereafter. The November edition will focus on holistic health.