QDIS Blog

A blog about chemistry, drug development, science, and technology

July 7, 2006

More Muck for Merck

by @ 11:55 am.  Filed under FDA, Pharma News, Pharma

Seems Merck can’t get a break. First there is the ongoing Vioxx mess and then there was a positive development with the approval of Gardasil vaccine for cervical cancer followed by the Center for Disease Control (CDC) recommendation that it be given to all girls age 11-12. Now, the LA Times is reporting on the growing concern and beginnings of lawsuits regarding Fosamax (alendronate sodium), Merck’s treatment for osteoprosis.

Another Merck Drug Is Under Legal Attack - Los Angeles Times

It seems that Fosamax and other compounds in its class called bisphosphonates are linked to a condition called osteonecrosis. This is a rare condition which leads to deterioration of the jaw bone which can be extremely painful and debilitating. The question is, was this something Merck should have foreseen and is it something that should have been picked up earlier.

FDA has a Office of Drug Safety (ODS) Postmarketing Safety Review that was issued in August of 2004. The conclusion was that additional language should be added to the labels under adverse events. Here is a blog posting from Drug Injury Watch blog concerning this.

Here’s a screenshot of a search on Google for Fosamax (click the image for a larger view). Note that two of the three sponsored results at the top are for lawsuits and of the first seven ads on the right, three are for law firms.

200607071012

The same search on Yahoo! yields three of four results at the top for lawyers and only one out of eight for ads on the right column.

200607071017

Google trends is also interesting in that three FL cities; Miami, Orlando, and Tampa all are in the top ten cities searching for this terms. This is most likely due to the fact that the law firm of Levin, Papantonio, Thomas, Mitchell, Echsner, & Proctor, P.A. located in Pensacola, FL. One of their lawyers has filed over 30 lawsuits so far and expects to file more than 300 by the end of the summer.

200607071021

My take, this is going to be another major pain for Merck. It will be interesting to see how this develops in the coming months. Another thought is that at least two other companies Novartis [Zometa (zoledronic acid] )and Procter and Gamble [Actonel (risedronic acid)] have similar problems with similar drugs but don’t seem to be getting the negative press that Merck is receiving (they are however being looked at for lawsuits also).

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Related Posts:
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