The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine’s active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.
BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:
- are labeled with Roche as the manufacturer
- display batch numbers that start with B6010, B6011 or B86017
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.
RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:
- Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989,
- Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
- Email – DrugSupplyChainIntegrity@fda.hhs.gov
Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
The Health Gazette is no friend of “big pharma” and does not support the use of any drug unless absolutely essential. What is worse than bad drugs (ie, toxic chemicals, inadequately tested, unwanted side effects riddled, etc) is fake drugs. When the drugs that are prescribed do not contain what they purport to contain then very serious consequences can arise from their use. It does not matter whether the drug is a cytotoic anti-cancer drug or a simple over-the-counter analgesic, the risks posed are just as bad. Knowing what is in a bad drug is one thing, not knowing what is in any drug is even scarier.
Tags: Avastin counterfeit, MedWatch
The MedWatch January 2012 Safety Labeling Changes posting includes 63 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The “Summary Page” accessible via the following link provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm289859.htm
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
- Accupril (quinapril hydrochloride)
- Accuretic (quinapril HCl/ hydrochlorothiazide)
- Altace (ramipril)
- Avalide (irbesartan/hydrochlorothiazide)
- Avapro (irbesartan)
- Azor (amlodipine/olmesartan)
- Benicar HCT (olmesartan medoxomil/hydrochlorothiazide)
- Diovan (valsartan)
- Diovan HCT (valsartan/hydrochlorothiazide)
- Exforge (amlodipine/valsartan)
- Exforge HCT (amlodipine/valsartan/hydrochlorothiazide)
- Lotensin (benazapril)
- Lotensin HCT (benazapril/hydrochlorothiazide)
- Lotrel (amlodipine besylate and benazepril hydrochloride)
- Mavik (trandolapril)
- Micardis (telmisartan)
- Micardis HCT (telmisartan/hydrochlorothiazide)
- Tarka (trandolapril/verapamil hydrochloride)
- Teveten (eprosartan mesylate)
- Teveten HCT (eprosartan mesylate/hydrochlorothiazide)
- Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide)
- Univasc (moexipril hydrochloride)
- Uniretic (moexipril hydrochloride/hydrochlorothiazide)
- Ceftriaxone for Injection and Dextrose Injection in Duplex Container
- Evoclin (clindamycin phosphate)
- Mavik (trandolapril)
- Micardis (telmisartan)
- Micardis HCT (telmisartan/hydrochlorothiazide)
- Micardis HCT (telmisartan/hydrochlorothiazide)
- Twynsta (telmisartan/amlodipine)
- Xenical (orlistat)
- Chantix (varenicline)
- Erbitux (cetuximab)
- Fanapt (iloperidone)
- Fazaclo (clozapine)
- Gralise (gabapentin)
- Morphine Sulfate Oral Solution,
- Morphine Sulfate Tablets
- Nexium (esomeprazole sodium)
- Nexium (esomeprazole magnesium)
- Performist (formoterol fumarate)
- Pradaxa (dabigatran etexilate mesylate)
- Vimovo (naproxen/esomeprazole magnesium)
- Vytorin (ezetimibe/simvastatin)
Remember to exercise great care with drugs, whether prescribing or consuming. All drugs are dangerous. Only consume drugs that are truly essential. Unless persuaded to your satisfaction as to the essential nature of any prescribed drug, seek a second opinion. Ensure that you know exactly what a prescribed drug is intended to do and what side effects it may have and what alternatives exist to taking the drug.
Tags: MedWatch
The US FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.
FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.
Drugs of concern include:
- AcipHex (rabeprazole sodium)
- Dexilant (dexlansoprazole)
- Nexium (esomeprazole magnesium)
- Omeprazole (omeprazole) Over-the-Counter (OTC)
- Prevacid (lansoprazole) and OTC Prevacid 24hr
- Prilosec (omeprazole) and OTC
- Protonix (pantoprazole sodium)
- Vimovo (esomeprazole magnesium and naproxen)
- Zegerid (omeprazole and Sodium bicarbonate) and OTC
BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.
Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.
RECOMMENDATION: Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Information for Healthcare Professionals:
- A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
- Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
- Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
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
It is good that the FDA MedWatch system is in operation as it can respond to situations such as this one. How much better would it be however, if we were not always shutting the gate after the horse had bolted? Remember that this system is nothing more than an elaborate drug trial where unsuspecting consumers are effectively used as “lab rats.” This recent finding of a link between manipulated gastric acid levels and a bacterial infection is just one of the several problems associated with this line of treatment. These drugs are seriously over used anyway so let us hope some people will be motivated to seek more appropriate treatment.
Tags: Clostridium Difficile-Associated Diarrhea (CDAD), gastroenterology, MedWatch Alert, Proton Pump Inhibitors (PPIs)
Taken from the Vitamin D Council Newsletter
January 30, 2012 — Dr John Cannell
Every year, billions are spent in fertility clinics; the result of which is often in vitro fertilization (IVF). About 5 years ago, I began receiving emails from a nurse practitioner in Indiana who works in a fertility clinic. Her experience was dramatic; 5,000 IU/day for both the man and woman frequently resulted in a healthy baby. However, her last email to me was quite sad, she was in danger of losing her job as her boss, a gynecologist, was losing money due to vitamin D. He ordered her to stop advocating it or lose her job.
Today, the Daily Mail and several other newspapers reviewed a lengthy article in The European Journal of Endocrinology that concluded, “Given the high prevalence of infertility as well as vitamin D insufficiency in otherwise healthy young women and men and the possible role of vitamin D in human reproduction, research might lead to new therapeutic approaches such as vitamin D supplementation in the treatment of female and male reproductive disorders.”
Critical to this carefully caged advice is the fact that men need help as frequently as the women do. “Population-based studies found that in 30-40% of infertile couples the underlying cause is the male factor. In this context it should be mentioned that the overall semen quality of men is decreasing, which might partly be explained by environmental factors. Indeed, as much as 20% of young men have sperm concentration below the WHO recommendation level and 40% present with sperm concentrations below a level that is considered optimal for fertility.” Pretty amazing, especially when you realize these men have normal testosterone levels but that vitamin D levels are steadily decreasing.
The authors go onto say, “In northern countries, where a strong seasonal contrast in luminosity (sunshine intensity) exists, the conception rate is decreased during the dark winter months, whereas a peak in conception rate during summer leading to a maximum in birth rate in spring has been observed. Moreover, ovulation rates and endometrial receptivity seem to be reduced during long dark winters in northern countries.”
While no direct studies exist of vitamin D levels and fertility per se, the authors report, “In a study among 84 infertile women undergoing in vitro fertilization, women with higher levels of 25(OH)D in serum and follicular fluid were significantly more likely to achieve clinical pregnancy following in vitro fertilization . . .”
If you don’t want to work your way through the entire 42 page paper, read the excellent synopsis in the Daily Mail below.
The takeaway message is the same as always, a message so common I should just start saying “ditto.” If you want to get pregnant, make sure you and your partner take 5,000 IU/day. If you don’t want to get pregnant, make sure you and your partner are on 5,000 IU/day plus a reliable method of birth control. I take no responsibility for surprise pregnancies.
Nearly one third of Australian adults are suffering vitamin D deficiency according to a study involving more than 11,000 adults from around the country.
This is the first national study to evaluate the vitamin D status of Australians. Those at greatest risk for deficiency were women, the elderly, the obese, people doing less than 2.5 hours of physical activity a week, and people of non- European background.
The results highlight vitamin D deficiency as a major public health issue for Australia that requires urgent attention, said study leader Professor Robin Daly, Chair of Exercise and Ageing within the Centre for Physical Activity and Nutrition Research at Deakin University, and honorary fellow in the Department of Medicine (Northwest Academic Centre) at the University of Melbourne.
“Vitamin D deficiency is emerging as a major health problem worldwide. It is clear from the results of our study that, despite an abundance of vitamin D rich sunlight, Australians are not immune from this issue,” he said.
“Low levels of vitamin D can contribute to a number of serious, potentially life-threatening, conditions such as softened bones; diseases that cause progressive muscle weakness leading to an increased risk of falls, osteoporosis, cardiovascular disease, certain types of cancer and type 2 diabetes.
“While it was reassuring that only four per cent of the population had severely deficient levels, national strategies are urgently needed to attack the high prevalence of vitamin D deficiency in Australia before the problem worsens.”
For the study, the researchers measured the vitamin D levels of 11,218 adults aged 25-95 years from all six states and the Northern Territory as part of the Australian Diabetes, Obesity and Lifestyle (AusDiab) study conducted by the Baker IDI Heart and Diabetes Institute in 1999-2000.
The study revealed:
- 31 per cent of the population were vitamin D deficient
- Nearly three quarters (73 per cent) had levels considered by many experts as below the optimal for musculoskeletal health
- The prevalence of vitamin D deficiency increased with age, especially in women; 26 per cent of women aged 25-34 years were deficient which increased to 57 per cent for those aged 75 years and over. This is an important finding as vitamin D deficiency is a key risk factor for falls and fractures in the elderly.
- People of non-European origin were 4-5 times more likely to be deficient
- Those who were obese and physically inactive were around twice as likely to be vitamin D deficient
The prevalence of deficiency was also found to vary markedly by season and location, with deficiency more common during winter and in people residing in the southern states of Australia.
“For example, 42 per cent of women and 27 per cent of men living in the southern states were deficient during summer-autumn, which increased to 58 per cent of women and 35 per cent of men during winter-spring. Even in the northern states 31 per cent of women and 15 per cent of men were vitamin D deficient during winter-spring,” Professor Daly said.
Professor Daly and his co-authors from the University of Melbourne and the Baker IDI Heart and Diabetes Institute said it was timely and appropriate to develop national strategies across the whole population and further awareness campaigns for balancing safe sun exposure and adequate vitamin D intake to ensure optimal vitamin D status year-round for all Australians.
The results are published in the journal Clinical Endocrinology.
Notes
In this study vitamin D levels in the blood (also referred to as serum 25-hydroxyvitamin D) of less than 50 nmol/L represent deficiency and values less than 75 nmol/L represent insufficient level. Levels below 25 nmol/L are considered as severe deficiency.
Ethnicity was categorised into ‘Europid’ and non-Europid based on country of birth. The majority of participants were categorised as Europids which included those born in Australia, Northern Europe, Canada, USA and New Zealand. Non-Eurpoids included those born in Southern Europe, Asia, the Middle East, India and Sri Lanka, Pacific Islands, Africa and South and Central America.
Source: Deakin University