Sensipar
is a drug that can be problematic (dangerous?) when given to patients with
PRIMARY hyperparathyroidism. Sensipar (Cinacalcet) is NOT approved by the FDA for
treating patients with primary hyperparathyroidism. If your doctor
prescribed this drug for you, you should print this page of
parathyroid.com and take it to him/her. Sensipar is likely to make you
feel sick, and new evidence suggests that Sensipar can make your
osteoporosis worse if you take it. Most insurance companies will not
pay for this drug for treating primary hyperparathyroidism... and they
shouldn't! There is good evidence that taking Sensipar is worse for you
than if you took nothing and simply ignored the parathyroid tumor in your
neck! The pros and cons of taking Sensipar for primary hyperparathyroidism
are discussed on this page. In our opinion, there is almost never a
case where a patient with primary hyperparathyroidism should be on this
drug! DANGER! Again, this drug may make you significantly worse
and is not approved for patients like you!
| Update February 2013 from Dr Norman: Death due
to Sensipar. We have said Sensipar is dangerous
for many years and have seen many people made sick by Sensipar
(Cinicalcet). Yet Amgen (and the biased endocrinologists who are
on their payroll to do Sensipar research) keep trying to find ways
to sell this drug. This month (February 2013) the FDA told Amgen
to stop Sensipar research immediately after a 14 year old was
killed by this drug. I could have operated on that 14 year old and
removed the parathyroid tumor and cured the patient forever with
an operation that took 15-20 minutes. But instead, Amgen wants to
get rich by giving an expensive drug (for 50 years??) to a
teenager. These people don't need Sensipar to make them sick and
kill them, they need a talented surgeon to remove their tumor and
send them home for lunch. Read
about the death here. |
If you are on this page of parathyroid.com because you have
hyperparathyroidism and your doctor gave you a prescription for Sensipar
and you came home and typed "Sensipar" into Google... then you
are on the right web site... However, you may want to read about
hyperparathyroidism and parathyroid disease at the beginning
of this website and then come back here later. Make
sure you understand that taking a pill will not make the tumor in your
neck go away. Also, be careful, this is an advanced page and we will
confuse you if you haven't read more about parathyroid disease on our
other pages first.
Sensipar is a drug manufactured by Amgen. Sensipar is the trade name,
the generic name for this drug is "Cinacalcet". Sensipar comes
as a small pill in three strengths (30mg, 60mg, and 90mg). This drug was
designed for the treatment of SECONDARY hyperparathyroidism. Secondary hyperparathyroidism
is a disease that occurs in patients with kidney failure that are on
dialysis. These patients do NOT get parathyroid tumors like patients with
PRIMARY hyperparathyroidism. Patients with SECONDARY hyperparathyroidism
are usually treated with a combination of medications along with dialysis
to control all of the problems they have with the chemical balance of
their blood (due to the lack of kidney function).
Patients with PRIMARY hyperparathyroidism do NOT have kidney failure,
and are NOT on dialysis. This entire website (parathyroid.com) is
dedicated to the treatment of PRIMARY hyperparathyroidism. People with
PRIMARY hyperparathyroidism have high calcium levels, high PTH levels and
other issues (like kidney stones and osteoporosis) which are discussed on
this website extensively. We cannot confuse primary and secondary
hyperparathyroidism. Let us make this simple...if you have a parathyroid
problem, and you are not on kidney dialysis, then you have PRIMARY
hyperparathyroidism.
Sensipar was approved by the FDA for the treatment of SECONDARY
hyperparathyroidism in March 2004. This drug works well in many patients who are on
dialysis, and many thousands of patients with kidney failure are on this
drug. (Editorial note: truth be told, it is not a great drug for patients
with secondary hyperparathyroidism--not near the "wonder drug"
it was thought). IMPORTANT..Sensipar is NOT approved (nor does Amgen support its use) for
patients who are not on kidney dialysis. Sensipar is NOT FDA approved for the treatment of PRIMARY
hyperparathyroidism. This is why your insurance won't pay for it. They
shouldn't! Amgen--the maker of this drug, does not say this drug can be
used for primary hyperparathyroidism... and they know why --- It can make
things worse!
Several studies of Sensipar were conducted in patients with PRIMARY
hyperparathyroidism in the past few years (mid 2000's). Patients with
primary hyperparathyroidism were given Sensipar and the doctors measured
their calcium levels and PTH levels. The biggest study had a total of 40
(forty) patients getting Sensipar, while 38 got placebo (not a very big
study, was it?). The trial was to last 1 year. Only 28 of the 40 patients
taking Sensipar (70%) were able to stay on the drug for one year--the rest
got sick and were not able to take it. Of the 28 patients that took the
drug for one year, 73% had a decrease in their blood calcium levels. Only
7% of patients had a decrease in their PTH values. All the patients still
had the parathyroid tumor still in their neck, and even in patients who
had lower calcium levels, when the drug was stopped, their calcium and PTH
levels went back up--some even higher than before. The researchers did
uncover a potential problem, however, that the bones of these people may
not be any better, and they may be worse. This paper can be read here: Peacock
M, Bilezikian JP, et al. Cinicalcet maintains long-term normocalcemia in
patients with primary hyperparathyroidism. J
Clin Endocrinol Metab.
2005;90:135-141.
This was a well conducted study (and paid for by Amgen of course), and like other smaller studies (yep,
even fewer patients also paid for by Amgen), it shows that Sensipar will decrease the blood
calcium in about 3/4 of patients. However, since the PTH doesn't go down
in most people, it seems that the patient's bones are still exposed to
excess PTH. The evidence is that even though the calcium goes down, it
often CAUSES kidney failure and often makes osteoporosis WORSE. What is
most important, is that at least 40% of people can't even take this drug
because it makes them feel very sick (nauseated). See our
publication below: Sensipar makes people worse, not better!
Our Experience With Sensipar and Primary
Hyperparathyroidism.
We consult on over 3000 patients with PRIMARY hyperparathyroidism
annually (we do not see patients with secondary hyperparathyroidism who
are on dialysis). We have tried Sensipar quite a few times in the past for
patients who were operated on somewhere else who we could not operate on,
in order to see if the drug would make them feel better. We have also seen
hundreds of people referred to us over the years who have been put on this
drug because their doctor said that "surgery was too dangerous",
or because the local surgeon tried to operate and couldn't find the tumor.
Now, in 2013 our opinion is clear: Sensipar is a drug that hurts
people, makes them feel bad, and has no role in patients with primary
hyperparathyroidism. We call Sensipar "the devil's drug", as it
does nothing, makes people sick, decreases kidney function, and causes
osteoporosis to become worse. All this for $650 per month!
We have NEVER seen this drug help a person with primary
hyperparathyroidism. We have never seen this drug make somebody with
primary hyperparathyroidism feel better. We have never seen this drug make
somebody's osteoporosis better. We have seen hundreds of people made sick,
just so their doctor could show that the blood calcium level
decreased. Look folks, we are supposed to treat people, not
numbers.
We have parathyroid patients sent to us by about 600 different
endocrinologists every year. We can tell you this, the best
endocrinologists know Sensipar is a drug of the devil and would never give
it to a patient with primary hyperparathyroidism. We rarely see the really
good endocrinologists giving this terrible drug to patients.
In 2012 the FDA approved Sensipar for use in primary
hyperparathyroidism for patients who were "too sick to undergo
surgery". Folks, we've done more than 20,000 parathyroid
operations and have NEVER seen a patient that is too sick to have surgery.
If they can eat breakfast, they are healthy enough to have a
mini-parathyroid operation. Heck, once the tumor is out they are healthier
almost immediately since their heart will beat better and stronger within
hours of tumor removal. There is no such thing as a patient who is too
sick for parathyroid surgery. Even if there were, giving a drug to make
them feel bad is clearly NOT in their best interest. Nothing good will
happen by taking Sensipar except that the calcium level will drop. The PTH
level will remain high and the patients will become sicker, not
better.
This is a big pharma company (Amgen) who wants to make money selling a
drug that kills people and does not make them feel better. Our advice:
spend 20 minutes with an expert parathyroid surgeon and get the damn tumor
removed. There is no other disease that is so easy to cure!
Our experiences
with this drug are very poor, and we have written the FDA and Amgen to
make them aware of our findings... the abstract of our findings were presented at the biggest endocrine meeting
in 2010: and then published in 2012:
Cinacalcet
(Sensipar) provides no measurable clinical benefits for patients with
primary hyperparathyroidism and may accelerate bone loss with prolonged
use. Norman J, Lopez J, Politz D. Annals of Surgical Oncology
May;19(5):1466-71
