Safety Review of Proton Pump Inhibitors and Possible Increased Risk of Fracture of the Hip, Wrist, and Spine

6/28/2010
 

The Saudi Food and Drug Authority (SFDA) has revised the labels for a class of drugs known as proton pump inhibitors (PPIs) to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications at higher doses or long duration (more than one year).

The new safety information is based on several epidemiological studies that reported an increased risk of fractures of hip, wrist, and spine with PPIs use. Some studies found that those at greatest risk for these fractures are usually receiving high doses of PPIs or used them for one year or more .The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fractures primarily was observed in this age group.

Information for Patients and Consumers

  • Proton pump inhibitors are effective in treating a variety of gastrointestinal disorders. Do not stop taking your proton pump inhibitor unless told to do so by your healthcare professional.
  • Be aware that an increased risk of fractures of the hip, wrist, and spine has been reported in some studies of patients using proton pump inhibitors. The greatest increased risk for these fractures was seen in patients who receive high doses of these medications or use them for a year or more and who were over 50 years of age.
  • Read and follow the directions on the drug leaflet or label, when considering use of OTC proton pump inhibitors.
  • Be aware that the OTC proton pump inhibitors should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your healthcare professional. No more than three 14-day treatment courses should be used in one year.
  • Talk to your healthcare professional about any concerns you may have about using proton pump inhibitors.
Information for Healthcare Professionals
  • Proton pump inhibitors provide important benefits for many patients in treating or preventing conditions such as erosive esophagitis, nonsteroidal anti-inflammatory drug-induced ulcers and gastroesophageal reflux disease (GERD).
  • Be aware of the increased risk of fractures of hip, wrist, and spine seen in some observational studies in patients using proton pump inhibitors.
  • When prescribing proton pump inhibitors, consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.
  • Follow the recommendations in the product labeling when prescribing proton pump inhibitors.
  • Individuals at risk for osteoporosis should have their bone status managed according to current clinical practice, and should take adequate vitamin "D" and calcium supplementation.
  • Healthcare professionals, especially community pharmacists, should be aware that the over-the-counter (OTC) proton pump inhibitors should only be used for 14 days for treatment of frequent heartburn. No more than three 14 days treatment courses should be used in one year.

List of marketed product containing PPIs.

Trade Name

Generic Name

Nexium

Esomeprazole

Losec mups,

Omeprazole

Aciloc

Omeprazole

Emilok

Omeprazole

Epirazol

Omeprazole

Gasec Gastro

Omeprazole

Hyposec

Omeprazole

Gastrozole

Omeprazole

Ipproton

Omeprazole

Omedar

Omeprazole

Omeprex

Omeprazole

Omeral

Omeprazole

Omezyn

Omeprazole

Risek

Omeprazole

Oprazole

Omeprazole

Sedacid

Omeprazole

Lanfast

Lansoprazole

Lansomid

Lansoprazole

Lanzor

Lansoprazole

lonzet

Lansoprazole

LONZET

Lansoprazole

Peptazole

Lansoprazole

Takepron

Lansoprazole

Ultrazole

Lansoprazole

Pantomax

Pantoprazole

Pantover

Pantoprazole

Pantozol

Pantoprazole

Proton

Pantoprazole

Protoprazole

Pantoprazole

Razone

Pantoprazole

Toprazole

Pantoprazole

Pariet

Rabeprazole

Rabezole

Rabeprazole

The SFDA urges both healthcare professionals and patients to report side effects and product quality issues to the SFDA either online, by regular mail or by fax, using the following contact information :
National Pharmacovigilance Center (NPC)
Saudi Food and Drug Authority-Drug sector
3292 Northern Ring Road
Al Nafal District
Riyadh 13312 – 6288
Kingdom of Saudi Arabia
Email :
NPC.Drug@sfda.gov.sa
Website: www.sfda.gov.sa/NPC-E