Novartis Blood Pressure Medication Runs into Trouble
by Gary Pepper, M.D.
In 2007 a new type of blood pressure lowering medication was brought to market by Novartis Pharmaceutical Company. This medication by the brand name Tekturna (aliskiran) works by blocking hormones that make up a circuit from the kidney to the blood vessels know as the RAAS system. This mechanism is distinct from all other blood pressure lowering medications available. By working via a completely novel pathway to lower blood pressure doctors were given another potent weapon in the war on high blood pressure. A second medication, Valturna, which combines an established blood pressure medication with Tekturna, was released by Novartis to the public in 2009. These drugs have been extremely popular due to their effectiveness and apparent freedom from serious side effects.
A warning about this class of drug was issued by Novartis, 2 weeks ago when it was forced to end the Altitude drug study due to apparent unforeseen complications in patients using Tekturna and Valturna. The study found a small but significant increase in stroke in diabetics with renal disease who were using these drugs. Although the group of patients in the Altitude study are up to 12 times more likely to develop stroke or heart attack under normal circumstances, Novartis had no choice but to end the study and issue a warning to the health care community about limiting the use of these drugs.
In my own practice I have found Tekturna and Valturna to be extremely effective and well tolerated. A survey of my colleagues revealed the same findings. Diabetes and high blood pressure very commonly occur together and national guidelines stress the need for excellent blood pressure control for diabetics to help prevent heart, kidney and eye complications of this disease. For doctors treating diabetics who recognize these patients as particularly high risk, having to significantly cut back or eliminate the use of Tekturna and Valturna is creating major concerns. Within the past week I have had to counsel numerous individuals about these issues and the solution is far from easy. For instance, one man with diabetes and early kidney disease and heart disease, with borderline high blood pressure despite using 4 different types of blood pressure medication including Tekturna has to decide with me, which is the greatest risk, going off the medication resulting in a rise in his blood pressure or continuing a drug which may pose a risk of its own.
These discussions are going on in doctor’s offices throughout the country with no good solution in sight. The only certainty is a flood of ads by lawyers which begin, “Have you ever been on Tekturna or Valturna….”.
After 50 years of exemplary therapeutic use and despite a large devoted following, Armour Thyroid and related dessicated thyroid generics have virtually disappeared from pharmacies in the U.S. An air of mystery with suggestions of conspiracy surround the shortage. The level of distress among Armour users confronted by their inability to obtain the medication, is extraordinary. Adding to the turmoil and confusion is the manufacturers’ continued reliance on flimsy and unconvincing explanations for their actions.
Several concerned individuals contacted the FDA for clarification of the Armour situation and received a prepared statement in response. A copy of the FDA’s letter explaining the government’s stance was posted to metabolism.com by an involved member. After studying the letter I believe I can offer a good explanation for the situation. The explanation, as I see it, is grounded in the fact that several thyroid medications such as Armour Thyroid but also including synthetic t4 medications like Synthroid, existed before the FDA was given full regulatory power. In 1973 the Supreme Court empowered the FDA to regulate the use of prescription medications in the U.S.. This meant that all prescription drugs would have to demonstrate to the FDA’s satisfaction, safety and efficacy for specific indications before pharmaceutical companies could promote the use of their drugs. Medications like Synthroid and Armour, already vital components of medical therapy for years before 1973 entered a grey area of legitimacy after that time.
Just a few years ago, I was astounded to hear from my pharmaceutical representatives that Synthroid faced being banned by the FDA since it never provided the FDA with the type of documentation of safety and efficacy that all modern medications had. After 30 years the FDA decided it wanted to rescind the right of the drug manufacturer to promote this medication which was considered safe and effective way before the FDA achieved regulatory power. What followed was a tense year during which the manufacturer of Synthroid went through the costly and bureaucratically intricate process needed for FDA approval, which it ultimately won.
What I believe is happening now is a similar scenario with Armour Thyroid and other dessicated thyroid products. What convinced me of this is the wording in the FDA letter which refers to Armour Thyroid as an illegal drug. The FDA has put Armour on its Most Wanted List and is intimidating the manufacturer (and prescribing physicians) by implying the law is being broken by continuing to make and use this drug. In the case of Synthroid, which enjoys the full support by the medical community and provides millions of dollars in annual sales the financial equation was a “no-brainer” in favor of putting the money into the process to gain approval.
Not so for Armour Thyroid which has been defamed by the American Academy of Clinical Endocrinologists (AACE) and who’s use is much more limited and far less profitable to the manufacturer. I can imagine that the pharmaceutical company has already done the math and decided that not making Armour makes more financial sense that to continue making the “illegal” product and going through the FDA gauntlet for approval.
Where does that leave the patients who depend on dessicated thyroid preparations and the physicians who prescribe it? With no way to force the manufacturer to make the drug or to make the FDA to back down on its stance my guess is that Armour and related products will simply cease to exist and alternative prescriptions will have to be written. Please remember, I am the messenger here and do not sanction or in anyway condone what I see as the most likely outcome of this predicament. Perhaps by recognizing the existing reality a strategy can be developed to prevent this outcome.
Gary Pepper, M.D., Editor-in-Chief. Metabolism.com
The mission of the The Thyroid Project is to encourage sharing of information and experience between the public and the medical community about the treatment of hypothyroidism (low thyroid function). For at least the past few decades there is a growing awareness of â€œsomething missingâ€ in the way suffers of hypothyroidism are treated for their disease.
Too many patients, as documented in an on-line study of 12,000 individuals conducted by the American Thyroid Association published in June 2018, (https://doi.org/10.1089/thy.2017.0681) , complain of persistent symptoms of hypothyroidism despite what their doctors believe is successful treatment with levothyroxine (brands include Synthroid, Unithroid, Tirosent, Levoxl). We believe something needs to be done to resolve this conflict between patients and their doctors.
Without effective intervention the early stage of type 2 diabetes known as prediabetes carries a high risk of progressing to outright diabetes. Metabolism.com provides an up-to-date summary of recommendations from national authorities, for preventing and possibly reversing this life long affliction
Diabetes can be defined simply as elevated blood sugar levels. What exactly is high blood sugar and when should someone be concerned about their level? Does having prediabetes mean diabetes is around the corner? Metabolism.com tackles this tricky but important topic in this comprehensive review.
By Gary M. Pepper, M.D. Ozempic, Rybelsus, Trulicity, Wegovy, Saxenda are the central players in the weight loss craze sweeping across the globe. Metabolisim.com has been monitoring this phenomenon from its beginnings in 2008 with its report “Lizard Spit Reduces Blood Sugar and Appetite”, regarding the first drug in this class, Byetta (exenatide). Caught In the middle of the current chaos are the medical experts who treat diabetes and have been prescribing these medications for more than a decade. Here is a brief commentary from one such board certified endocrinologist; “I started treating Type 2 diabetics with GLP-1 agonists more than 10 years ago. In some respects, these medications have revolutionized the treatment of diabetes by lowering blood sugar effectively and promoting weight loss at the same time, a unique combination of benefits. Not everyone benefits from these drugs to the same degree unfortunately, and I have seen lots of patients experience unacceptable side effects from them. Nothing though, has prepared me for what is happening now. Too often, I find myself confronting someone who expects me to prescribe one of these drugs just so they can lose weight. Sadly, one extreme example was someone who, despite battling a life threatening medical condition, was insistent on getting a prescription. At the same time my diabetic patients are scrambling to find a place to buy their medications if they can even afford it. It is disheartening, to say the least, and I dread the negative interactions with some of my patients I now face almost daily.”
Off- Label Use
The FDA is the U.S. government’s department tasked with evaluating and approving drugs for specific medical conditions. When a new medication is approved for treating a medical condition by the FDA the agency will, at the same time, set strict guidelines for exactly which patients may use the newly approved drug. When a medication is used “off-label” it means that these limitations are being overridden by the provider for a potential benefit which outweighs the drugs risks. It is a general misconception that off-label means illegal; it does not. This practice has been going on for ages and more than 20% of prescriptions in the United States are prescribed off-label. A common example is the use of beta-blockers (approved for heart problems) for the treatment of performance anxiety.
GLP-1 agonist drugs, as discussed recently by metabolism.com. were originally approved for the treatment of Type 2 diabetes in adults. In the past few years most of these same medications have gained unprecedented popularity for their “off-label” weight loss benefit. Of the 5 GLP-1 agents presently in U.S. pharmacies only Wegovy (semaglutide) and Saxenda (liraglutide) are FDA approved for treating obesity. Of these two, Wegovy is the newer and had been much more popular that its sister drug Saxenda, probably due to being dosed only once weekly compared to daily for Saxenda and less likely to cause side effects. Due to Wegovy’s soaring popularity, its manufacturer, Novo Nordisk, increased the price of Wegovy two times since its initial release.