At Conference, Merck Responds to FDA Inquiries About Fosamax
At today's FDA Panel conference on the long term use of osteoporosis drugs like Fosamax, presenter Arthur C. Santora MD, PhD, speaking for Merck, the drug manufacturer, attempted to convince the panel that limits on the duration of the drugs use were not necessary. However, Dr. Santora did admit that drug "holiday" (meaning a temporary interruption in usage) may be considered for patients who are no longer considered to have a sufficiently high fracture risk.
Explaining further, Dr. Santora said that it would be advisable for every patient to be evaluated periodically for their risk of fracture and the ongoing benefit. However, on the issue of adverse events form Fosamax use (like osteonecrosis of the jaw and atypical femur fractures), Dr. Santora indicated that there is insufficient data for considering the effect of interruption of drug ingestion would have on the incidence rate for adverse events. Attempting to bolster Merck's position favor of long term Fosamax use by citing to two 10 year studies which admittedly had insufficient evidence to make conclusion about adverse events, Dr. Santora claimed that neither restricting the duration of use nor implementing a drug holiday is likely to be beneficial for patients at sufficiently high fracture risk who require long-term treatment.
Members from the public were also briefly heard from on the issue of long term use and serious concerns were presented along with pleas to the FDA to consider the impact of adverse events thoroughly and in-depth. Today's FDA sponsored conference is a Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement, taking place University of Maryland University College. The committees is discussing the benefits and risks of long-term bisphosphonate use for the treatment of osteoporosis given the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) that may be associated with the long-term use of Fosamax.