For millions of Americans taking oral bisphosphonates prescribed for osteoporosis, the jury is still out on whether these drugs are linked to an increased risk for esophageal cancer, according to the FDA’s latest drug safety announcement. Common brand names of medications in this class include Fosamax, Actonel, Boniva, Atelvia, Didronel and Skelid.

The FDA announcement cites conflicting research and the need for further study before a determination is made. One study found no increase in the risk of esophageal cancer. The second study found a doubling of the risk of esophageal cancer among patients who had 10 or more prescriptions of the drugs, or who had taken the drugs over 3 years. Other external researchers investigating this issue, using different patient databases, have reported no increase in risk, or a reduced risk.

While the FDA continues to review studies on the possible connection, here’s what they suggest those taking bisphoshonates should do in the meantime.

• Follow directions for use of any oral bisphosphonate drug carefully. All oral bisphosphonate drugs, except Atelvia, should be taken first thing in the morning after awakening, with a full glass of plain water. Atelvia should be taken immediately following breakfast. Do not lie down or eat or drink anything for at least 30 to 60 minutes after taking any oral bisphosphonate drug.
• Talk to your healthcare professional if you develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when you swallow. These may be signs of problems of the esophagus.
• You should not take oral bisphosphonates if you have esophageal conditions that delay emptying of the esophagus, or if you cannot stand or sit upright for at least 30 to 60 minutes, or have low calcium levels in your blood.
• Talk to your healthcare professional about the benefits and risks of taking oral bisphosphonates and how long you should expect to take them.
• Discuss any questions or concerns about your oral bisphosphonate drug with your healthcare professional.
• Report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.

At this time, the FDA believes that the benefits of oral bisphosphonate drugs in reducing the risk of fractures in people with osteoporosis continue to outweigh their potential risks. It is also important to note that esophageal cancer is rare, especially in women.

Source:

FDA