Its day 20 since Xofigo production stopped. How are you? Please email Joel at about how the Xofigo shutdown has affected your life.

Bayer has issued a public statement about the shortage of Xofigo (radium Ra 223 dichloride). After reviewing their statement I find that there is no new information that we haven’t already shared on this blog.

To summarize the important points in the release:

1- Bayer detected foreign material in the drug during its normal and routine inspection process.
2- Because of the existence of this foreign material Bayer suspended production of Xofigo
3- Bayer continues to search for the point at which this foreign substance has been introduced so they can prevent it from entering into the Xofigo.
4- Bayer is working to resolve the problem around the clock and will not begin production until the problem is resolved.
5- Bayer is also working with the FDA to insure the safety of all patients taking the drug.
6- Bayer again said that any product that had been released and used prior to the development of this problem passed all inspections and was safe.
7- Bayer suggests that patients speak with their doctors about their individual situation given the lack of Xofigo.

This release did not provide any projected dates for the resolution of this problem and for when production will again commence.

Bayer has stated that men whose protocol was interrupted should speak with their doctor to help them decide what should be their next step. Malecare believes that this is very important since it will most likely be many weeks, if not months, before Xofigo might be available to patients.

Malecare is committed to keeping everyone fully informed about this situation. We hope that the engineers at Bayer are able to quickly resolve this problem so that the flow of this vital drug can again become available to the many men in need.

Bayer’s formal statement can be seen at: Bayer Xofigo Statement 10/21.

Joel T. Nowak, M.A., M.S.W.