Evidence tying the use of <"http://www.yourlawyer.com/topics/overview/oral-osteoporosis-bisphosphonates-esophageal-cancer-lawsuit">oral bisphosphonates, a class of drugs that includes Fosamax, Actonel, Boniva, Atelvia, Didronel, and Skelid, to esophageal cancer is inconclusive so far, according to a Drug Safety Communication issued today by the U.S. Food & Drug Administration (FDA). Despite such conflicting studies, the agency said that for now, it continues to believe that the benefits of bisphosphonates continue to outweigh their risks.
The FDA’s review of a possible esophageal cancer – bisphosphonate link is ongoing, however, and the agency said larger studies of the drugs may be needed.
Two of the largest studies the FDA has reviewed to date both drew data from the U.K. General Practice Research Database or GPRD. One of those studies, published last year, found a doubling of the risk among patients who had 10 or more prescriptions of the drug or had taken the drug for longer than 3 years. However, the other study reported no increased risk.
For now, the FDA is advising patients taking oral bisphosphonates to carefully follow their directions for use (i.e. take them first thing in the morning with a full glass of water; avoid lying down, eating or drinking for at least 30 to 60 minutes after taking an oral bisphosphonate). Anyone taking these drugs should report swallowing difficulties, chest pain, and new or worsening heartburn to their doctors as these may be symptoms of an esophagus problem. Finally, oral bisphosphonates should not be taken by anyone with a condition that causes a delay in emptying of the esophagus, as well as anyone who cannot stand or sit upright for at least 30 to 60 minutes, or suffers low blood calcium levels.
Oral bisphosphonates are used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget’s disease. The drugs do have the potential to cause esophagitis (inflammation) or esophageal ulcers, but according to the FDA, the risk of these side effects is low when oral bisphosphonates are prescribed appropriately and the specific directions for use are followed by patients.
Bisphosphonates have also been associated with other serious side effects, including osteonecrosis of the jaw (aka dead jaw syndrome) and atypical fractures of the thigh. Warnings for thigh fractures were added to the labels of bisphosphonates last year, and the labels were updated with information regarding jaw problems in 2005
On September 9, an FDA advisory panel will convene to discuss the safety issues surrounding bisphosphonates.