Download A) The most common adverse effects reported with bisphosphonate

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BISPHOSPHONATES
Gastrointestinal
SUMMARY
A) The most common adverse effects reported with bisphosphonate therapy are
gastrointestinal disturbances (nausea, diarrhea, abdominal pain, and taste perversion).
Potentially more serious effects have included ulcerations of the gastrointestinal tract.
3.8.2) CLINICAL EFFECTS
A) GASTROINTESTINAL COMPLICATION
1) WITH THERAPEUTIC USE
a) Gastrointestinal adverse effects are commonly reported following bisphosphonate
therapy. Effects can include: nausea, diarrhea (etidronate), and gastrointestinal
(esophageal, duodenal, and stomach) ulcers with second and third generation
bisphosphonates. Other symptoms may include: abdominal pain, vomiting, and
esophagitis/gastritis.
b) In a review of adverse effects reported following bisphosphonate use, the incidence of
corrosive esophagitis is low; however, when complications occur they tend to be
severe(Lanza, 1998).
RISK FACTORS : Patient's with a history of chronic reflux esophagitis, Barrett's
mucosa, and patients with motility or stricture disease should avoid therapy with
bisphosphonates . Also, patients that are debilitated or bedridden may be at greatest risk
for gastrointestinal complications following therapy. (Lanza, 1998).
c) ALENDRONATE
In clinical studies adverse experiences were similar for patients taking alendronate
40 mg/day (Paget's disease) and 10 mg/day (postmenopausal women) except for upper
gastrointestinal adverse effects (17.7% with alendronate and 10.2% placebo)(Prod Info
FOSAMAX(R) oral tablets, solution, 2010) .
PUBMED (secondary source)
http://www.ncbi.nlm.nih.gov/pubmed/11048968
Alendronate-related oral mucosa ulcerations.
Gonzalez-Moles MA, Bagan-Sebastian JV.
Abstract
Alendronate is widely used in the treatment of osteoporosis and other bone diseases.
Although it is considered a well-tolerated drug, there are numerous reports of adverse
effects on the mucosa in the upper aerodigestive tract, with oesophagitis as the most
common complication. The strict regulations for the proper administration of the drug
indicate that these side effects might well be the result of a direct, irritant mechanism on
the upper aerodigestive tract. We present two clinical cases of patients who developed
extensive palatal ulcers as a result of taking alendronate. We discuss possible mechanisms
implicated in the production of the ulcers and some clinical factors of interest.
Keyword: bisphosphonate and ulcer
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Upper Gastrointestinal Adverse Reactions
FOSAMAX, like other bisphosphonates administered orally, may cause local irritation of the
upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for
worsening of the underlying disease, caution should be used when FOSAMAX is given to
patients with active upper gastrointestinal problems (such as known Barrett's
esophagus, dysphagia, other esophageal diseases, gastritis,duodenitis, or ulcers).
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal
erosions, occasionally with bleeding and rarely followed by esophagealstricture or
perforation, have been reported in patients receiving treatment with oral bisphosphonates
including FOSAMAX. In some cases these have been severe and required hospitalization.
Physicians should therefore be alert to any signs or symptoms signaling a possible
esophageal reaction and patients should be instructed to discontinue FOSAMAX and seek
medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or
worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie
down after taking oral bisphosphonates including FOSAMAX and/or who fail to swallow oral
bisphosphonates including FOSAMAX with the recommended full glass (6-8 oz) of water,
and/or who continue to take oral bisphosphonates including FOSAMAX after developing
symptoms suggestive of esophageal irritation. Therefore, it is very important that the full
dosing instructions are provided to, and understood by, the patient [see DOSAGE AND
ADMINISTRATION]. In patients who cannot comply with dosing instructions due to mental
disability, therapy with FOSAMAX should be used under appropriate supervision.
There have been post-marketing reports of gastric and duodenal ulcers with
oralbisphosphonate use, some severe and with complications, although no increased risk
was observed in controlled clinical trials
http://www.rxlist.com/fosamax-drug/warnings-precautions.htm
Key word: alendronate/esophagitis
alendronate administration via oral route can local irritation of the upper gastrointestinal mucosa.
The most common adverse effects reported with bisphosphonate therapy are nausea,vomiting,
diarrhea and abdominal pain. Potentially more serious effects have included ulcerations of the
gastrointestinal tract such as esophagitis.