Generally, teriparatide is well tolerated.
The most common side effects, among others, are dizziness, nausea,
heartburn, diarrhea, headache and leg cramps, pain, weakness,
and depression. Lowered blood pressure (hypotension) when standing
can occur with the first few doses but does go away in a matter
of hours. Patients may be told to lie down after the injection.
There have been some cases of slightly elevated serum calcium,
and elevated calcium in the urine (which can lead to kidney stones).
Ooccasionally transient hypercalcemia occurs 4 to 6 hours after
injection, reducing blood serum calcium concentrations.
If any of these side effects persist or worsen, the prescribing
doctor should be informed. More serious reactions have included
chest pain, fainting, difficulty breathing, more severe nausea,
vomiting, constipation, and muscle weakness. Allergic reactions
can occur, from itching at the injection site to more serious
symptoms of allergy including swelling, and difficulty breathing.
Serious side effects warrant immediate medical attention.
When teriparatide was given to growing young rats, they developed
osteogenic sarcoma, a very malignant tumor. The drug should not
be given to anyone at risk for developing this bony cancer. That
would include patients with Paget’s disease, those with elevated
alkaline phosphatase (which could indicate a problem in bone),
patients who had radiation therapy to their bones, or children
and young adults whose bones are still growing.
At this time, the recommended length of treatment is two years.
There are many ongoing clinical trials to determine the best way
to use teriparatide, with other medicines like alendronate, how
long treatment should last, and which patients with osteoporosis
will benefit the most from it. There have been attempts to deliver
the medication as a nasal spray instead of injection. It is also
being tested for other conditions. One, called osteogenesis imperfecta
is a genetic bone disease causing brittle bones. Teriparatide
is being tried as a treatment for adults with osteogenesis imperfecta.
It is also being tested as an aid to fracture healing. There are
some 50 trials in various stages at this time, and new uses for
teriparatide will probably be found.
The approved dose (20Fg daily by subcutaneous injection) and
duration of treatment have not been found to be associated with
an increased risk of osteosarcoma in humans.
The AFP's
guidelines, based on a systematic evidence review of previously
published studies. |