Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs.
Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription.
the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients. Continue reading
Morphine pumps dangerous glitch – SFGate – San Francisco Chronicle
For thousands of chronic pain sufferers, the Medtronic implantable morphine pump has been a godsend.
The size of a hockey puck, the high-tech gadget is tucked surgically under the skin of the abdomen — primarily in injury and cancer patients — and drips morphine and other painkillers from a reservoir directly into the spine.
But a dangerous complication, once thought extremely rare, has now turned up in scores of patients.
An inflamed mass of tissue develops at the tip of the tube where the drug enters the spine.
These “granulomas” can grow to the size of a golf ball, compressing the spinal cord and causing paralysis — either suddenly or slowly, and often irreversibly. With mounting urgency, surgeons are attempting to pinpoint why this is happening.
One possible culprit: the use of unapproved drugs to refill the half-ounce reservoirs during monthly visits to the pain clinic.
It has become a common practice in pain management to refill the pump’s built-in tank with medicines made from scratch by community druggists known as “compounding pharmacists.”
As we know from the New England case where hundreds of patients were poisoned by non-sterile compounded drugs injected into their spines, this industry is not tightly regulated.
Doctors can order all kinds of exotic mixes to be compounded for injection into the spine through epidural injections or implanted pain pumps. Such creative compounding is NOT regulated like oral drugs, so it’s the “wild west” of pain management.
Instead of prescribing the FDA-approved morphine, known as Infumorph, doctors can order higher concentrations of compounded morphine, or mix it with other medications such as clonidine that enhance the painkiller’s effect.
Compounders — druggists who make up all kinds of medicine from bulk powders — also make the painkillers dilaudid and fentanyl for use in the pumps.
MAKING MONEY FROM MIXING
Mixing morphine for use in pumps is a lucrative business for both compounders and the doctors who buy it.
Less than $5 worth of powdered morphine is needed to refill the pump for a month. Reimbursements to physicians who refill the pumps can be as high as $1,000 a month, although Medicare will pay about $250 for eligible California patients.
But the number of reports of granuloma cases — most of which have been found in the past two years — has sent pain doctors and Minneapolis pump- maker Medtronic scrambling.
“The fact of the matter is we do not know with medical certainty what causes these granulomas,” said Scott Ward, president of Medtronic’s neurological and diabetes division
NUMBERS APPEAR TO GROW
The first pump granuloma case was reported in 1991. Most recently, 41 were identified in the journal Neurosurgery by Dr. Kim Burchiel of Oregon Health & Science University and Dr. Robert Coffey of Medtronic.
Burchiel confirmed that since the article was submitted a year ago, the number of cases has grown to at least 74
The inflammation may be a chemical irritation “related to the properties of morphine itself.”
PHARMACIST SEES RISKS
Pharmacist Sarah Sellers, a consultant to an FDA advisory committee on pharmacy compounding, has been a longtime critic of using compounded drugs to fill implantable pumps.
Because compounders make the refills from bulk, unsterile powders, Sellers said, there is a risk of contamination not only from processing chemicals, but also from organic debris that can slip through filters designed to strain out bacteria.
Nevertheless, pain doctors contacted by The Chronicle are skeptical that the use of compounded drugs is related to the growing number of pump-related paralyses.
Sellers said that compounded drugs simply shouldn’t be used in morphine pumps tied directly to the spine.
When we take a drug orally it is exposed to and broken down by our caustic digestive juices, which can mitigate sterility and pollution problems.
But when a drug is injected directly into the major highway of our whole nervous system, our body cannot defend itself against any impurities.
“There’s nothing in the scientific literature to support these drug mixtures,” she said. “They are experimenting with patients, and billing a lot of money for it.”
Regular use of over-the-counter non-steroidal inflammatory drugs (NSAIDs) such as aspirin and ibuprofen is associated with an increased risk of dying in patients diagnosed with Type 1 endometrial cancers,
In this observational study, a multi-institutional team of cancer researchers sought to understand the association of regular NSAID use and the risk of dying from endometrial cancer among a cohort of more than 4,000 patients.
They found that regular NSAID use was associated with a 66 percent increased risk of dying from endometrial cancer among women with Type 1 endometrial cancers, a typically less-aggressive form of the disease.
This danger is never mentioned in the CDC’s recommendation to use NSAIDs instead of opioids. Continue reading
The ~5% chance of addiction is driving damaging healthcare policies, like suggesting we all take NSAIDs instead of opioids for our chronic pain.
Here’s what the CDC isn’t telling anyone:
NSAIDs have terrible side effects.
Common painkillers such as ibuprofen and diclofenac that are used by millions of people in the UK have been linked to an increased risk of heart failure, according to new research published in the British Medical Journal.
With a family history of breast cancer, Marcie Jacobs decided in June 2001 that an MRI screening was her best preventive option.
As is common with MRIs, Jacobs was injected beforehand with a contrast agent, a drug that helps sharpen the resulting images.
But after a few of these treatments, she began noticing some strange cognitive effects.
Jacobs began missing meetings. Over the next several years she had additional MRIs. The math skills that were crucial to her job as finance manager started deteriorating, she said. Continue reading
WARNING: Yoga can lead to crippling injuries
from unusual and excessive stress
on joints and blood vessels.
Yet, Yoga is now highly recommended by all opioid guidelines and is highly touted in the media as a “cure” for chronic pain.
Anyone with a connective tissue disorder is especially vulnerable to yoga injuries and should think carefully about the risks before taking up yoga. Continue reading
Beverage temperature tied to cancer risk – Harvard Health – September 2016
A working group of 23 scientists convened by the International Agency for Research on Cancer of the World Health Organization has evaluated the carcinogenicity of coffee, tea, and other hot beverages and has exonerated all of them
On the other hand, the scientists determined that almost any nonalcoholic beverage, when consumed at temperatures above 150° F, may contribute to the risk of esophageal cancer. They even found limited evidence implicating hot water.
The report reversed a 1991 ruling, which designated coffee drinking as “possibly carcinogenic to humans.” But after reviewing more than 1,000 studies conducted in the past 20 years, the panelists were unable to find conclusive evidence that any nonalcoholic beverage, served at lower temperatures, contributes to cancer.
Habitual heavy alcohol consumption, however, is still a major cause of esophageal cancer, along with smoking. The report appeared June 15, 2016, in The Lancet Oncology.
If you’ve been drinking your coffee or tea steaming hot, you may want to let it cool a few minutes before taking the first sip.
You may even like the change—many people find that subtle flavors come through at lower temperatures. And if you’re ordering at Starbucks—which serves its brews at 175° F or higher—you may want to ask for the “kid’s temperature” (130° F), at which hot chocolate is served.
Twenty minutes may be all it takes to identify a case of acetaminophen (APAP) poisoning, according to the developers of a new test for the condition […in] patients with liver failure related to the drug.
In a recent study, the 20-minute test (AcetaSTAT, Acetaminophen Toxicity Diagnostics) was performed as well as the current gold standard, high-performance liquid chromatography with electrochemical detection (HPLC-EC), to detect APAP toxicity.
Both techniques look for a biomarker produced after exposure to excessive and toxic amounts of the [non-opioid] painkiller.
AcetaSTAT rapid test results were consistent with the HPLC-EC assay and discriminated between APAP and non-APAP [acute liver failure],” the researchers reported. The test had a sensitivity of 97%, a specificity of 83%, a positive predictive value of 88% and a negative predictive value of 96%.
Using of non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 years is associated with an increased risk fatal renal cell carcinoma (RCC), researchers reported at the 2016 Genitourinary Cancers Symposium in San Francisco.
Regular use of non-steroidal anti-inflammatory drugs for 10 years or more increased the risk of dying from renal cell carcinoma nearly 4-fold.
In a pooled multivariate analysis, regular use of aspirin was not significantly associated with RCC risk, but regular use of non-aspirin NSAIDs was associated with a significant 34% increased risk. Continue reading
Prenatal exposure to acetaminophen may increase autism spectrum and hyperactivity symptoms in children | July 1, 2016 | Oxford University Press (OUP)
A new study has found that paracetamol (acetaminophen), which is used extensively during pregnancy, has a strong association with autism spectrum symptoms in boys and for both genders in relation to attention-related and hyperactivity symptoms.
This is the first study of its kind to report an independent association between the use of this drug in pregnancy and autism spectrum symptoms in children. Continue reading