This information is an update to the FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together issued on May 12, 2016
Some signs and symptoms of serious side effects include:
- unusual joint or tendon pain,
- muscle weakness,
- a “pins and needles” tingling or pricking sensation,
- numbness in the arms or legs,
- confusion, and
Recall of Zimmer Biomet’s Spinal Fusion Stimulators – May 31, 2017
Just when I thought electric stimulation could not possibly be damaging:
Zimmer Biomet has recalled the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals,
“which may be toxic to tissues and organs, and that were found during the company’s routine monitoring procedure,” according to a release from the US Food and Drug Administration.
How are “harmful chemicals” released by an electric stimulator? Nowhere in the article are the specific “harmful chemicals” listed. Continue reading
Op-ed: Demonizing opioids endangers lives, too | The Salt Lake Tribune – By Julieann Selden – Apr 2017
Another example of the dangers of NOT using opioids to control pain.
Potential opioid benefits are glaringly absent from the campaign billboards and websites.
Extreme pathos warns Utahns to “steer clear of opioids,” suggesting Tylenol and exercise as alternatives.
The rhetoric is guilt-inducing, unrealistic to many situations, and diminishes the credibility of the campaign. Continue reading
Yes, people can die from opiate withdrawal – Wiley Online Library -Shane Darke, Sarah Larney, Michael Farrell – Aug 2016
It is generally thought that opiate withdrawal is unpleasant but not life-threatening, but death can, and does, occur. The complications of withdrawal are often underestimated and monitored inadequately.
Death is an uncommon, but catastrophic, outcome of opioid withdrawal.
So, why do so many doctors believe that simply discharging a pain patient, whether out of fear of the DEA or even for lack of compliance, causes no harm? Continue reading
And yet another article on the overuse of epidurals, showing how they are being used to generate more profit for “interventional” pain specialists.
Epidural steroid injections are being used too often to treat back pain, in part because of an insurance compensation system that encourages doctors to generate more income by using the procedure, several leading experts in pain management have told Pain News Network.
Critics say epidural injections are overused and patients risk permanent damage to their spinal cords if they get the shots too often. Continue reading
Below is another article on the dangers of epidural injections. This procedure isn’t so popular because it bestows benefits on the recipient as much as because insurance companies compensate them so well.
Beware of worthless procedures and epidural steroids for your back pain – KevinMD – Cathryn Jakobson Ramin | Conditions | April 29, 2017
in a 2015 review of the medical literature, the Agency for Healthcare Research and Quality had found no evidence that epidural steroid injections were effective in treating symptoms of spinal stenosis or typical lower-back pain. Continue reading
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.