The Valsartan Recall by Steven Mussey MD
Based on what I can figure out, Valsartan was being produced in large quantities in Linhai, China and being supplied to pharmaceutical manufacturers across the globe. Unfortunately, it was contaminated by N-nitrosodimethylamine, a carcinogen.
It sounds like this has been going on for years.
This is not reassuring. Reading Wikipedia, which is what most of our patients are doing, we find this:
N-Nitrosodimethylamine is highly toxic, especially to the liver, and is a known human carcinogen. The US Environmental Protection Agencyhas determined that the maximum admissible concentration of NDMA in drinking wateris 7 ng L−1.[5]The EPA has not yet set a regulatory maximum contaminant level (MCL) for drinking water. At high doses, it is a “potent hepatotoxinthat can cause fibrosisof the liver” in rats.[6]The induction of liver tumors in rats after chronic exposure to low doses is well documented.[7]Its toxic effects on humans are inferred from animal experiments but not well-established experimentally.
Crap! This sounds horrible!
But, rest assured!!
Your United States Government and all of the various private and public medical agencies, professional societies, monitoring groups and FDA are right on this!
NOT!
Let’s just look at a few of the screw-ups:
- The first recall before the weekend indicated it did not impact the Valsartan supply in the U.S.
Thus, we told our patients not to worry when they called in a panic. Then, the FDA came out on that Monday with a statement that generic supplies in the U.S. were being recalled for the same reason. Unless doctors are glued to CNN, instead of seeing patients, they missed it.
Our assurances were, of course, false and patients got ugly. Fortunately, we caught it early by doing a quick Google News search.
So: Why the delay, FDA?
- Insurance drug coverage immediately went into helpful action: It blocked doctor attempts to move patients to similar drugs.
Valsartan is a more potent ARB. Most Valsartan users had failed weaker ARB’s like Losartan. Yet, this was the drug demanded by insurances.
Attempts to use a more appropriate drug of equal power, such as Olmesartan, resulted in denial by insurance.
- The bigger pharmacies were caught unprepared and dumped all of their work onto the doctors.When patients called the pharmacy with basic questions, all they got in response was “Call your doctor.”
Some local pharmacists were notable exceptions and stepped up to the task. They deserve praise.
On the other hand, the bigger the pharmacy, the more they dumped onto the doctors. I am not making this up!
Example: “Which manufacturer made my Valsartan?”
Pharmacy answer: “Call your doctor.”
Patient: “But you dispensed it.”
Pharmacy: “Call your doctor.”
Example: “My drug manufacturer is not on the recall list. Am I okay?”
Pharmacy answer: “How should we know? We just dispensed it. Call your doctor.”
Example: “What was the poison in the drug?”
Pharmacy: “Call your doctor.”
The result was an avalanche of phone calls to our office with questions we simply could not answer.
- The FDA’s announcement was incomplete.Brand name Valsartan (Diovan) was not clearly mentioned. There was an implication that combination products were not impacted but I have yet to see such a statement.
There was no clear listing of “safe” manufacturers
- Even the method of communicating the recall was half-baked.There were no emails or rapid fire communications techniques. Doctors were left to read the announcement on a news site.
- What is the impact of being exposed to this carcinogen? How much of this carcinogen was present in the medication? How long has it been present?
No official word. Zero. Nobody seems to have any idea.
No testing appears to have been done.
Patients grew angry and terrified as the week went on. It would have been nice if the Pharmacy plans or FDA could have printed a one page handout to give to patients.
Instead, the response from pharmacies and the FDA: “Call your doctor.”
- Mass population exposure for several years to a “highly toxic… carcinogen” (quoting Wikipedia) sounds totally terrifying.
Yet, Pharmacy Benefits Plans sent out faxes five days later, trying play down the seriousness.
- There was total silence from groups which pretend to “help” doctors practice quality medicine.
On an average day, there are a multitude of agencies, pharmacies, insurance plans, state and federal agencies, State Medical Boards, etc., who can’t wait to intervene and get in our faces as doctors.
Yet, when the medical community needs real help, there is silence!
Deafening…. Total…. Silence…..
Even the American College of Physicians, which eats a ton of my money each year, was deathly silent.
When we actually need help and a public health problem pops up, none of these groups are available for information or assistance.
So, our week was packed with frantic phone calls, reassurances, drug switches, drug switch denials, and hysteria.
There are far too many overpaid administrators who are too damn interested in collecting dues, bullying doctors, getting kickbacks and being lazy.
Yet, when pharmaceuticals are contaminated with dangerous toxins, we get a wimpy response.
I hope someone slips a big dose of Valsartan into their drinks!
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Our tech guy saw the news Sunday, pulled our valsartan patient list from registry and by Tuesday pm everybody had been called. Some of the pharmacies were helpful, one chain, the one that has a color in the name, apparently decided at the corporate level to play stupid (not a hard job for them). We just referred them to the pharmacy and if they said they didn’t know which manufacturer’s meds they put in the bottle we called in another ARB at (if OK with the patient ) at a different pharmacy.
Well done! My pharmacy at Costco was as helpful as they could be. Answering my questions about comparing efficacy of drugs. Where to find info on NDMA a website or Google it. Wonderful people. Called my doctor for the replacement and had it ready within 24 hours!
Love Costco!!!
Another strong affirmation of DPC. The factory-floor model of hypertension, the measure-and-drug 10 minute visit, is based on the assumption that pharmacology = care. Non-drug methods take time and patience.
If the Ivory Tower researched DPC rather than criticized it, they might find a lower drug burden on patients.
Thanks for the update. I was aware of a recall and not informed as to why.
Another reason to not condone overconsolidation of suppliers.