Merck’s Whistle Blowing Just Got Louder
After a storm of commotion in light of Merck & Co’s drug Tredaptive, which was found (when added to statins) not to reduce major vascular events as it’s supposed to, the company has taken it upon themselves to update the public on the latest developments.
The latest news is that the company (after reporting the drug’s limitations to the European Medicine’s Agency) is now currently taking the right steps to suspend the availability of Tredaptive.
The decision is based on the understanding of data released from a study and consultations with regulatory authorities. Aside from Tredaptive’s failure to reach its role in reducing major vascular events, there was further evidence illustrating a significant increase in the incidence of some forms of serious (albeit non-fatal) side-effects, compared to statin therapy alone (see Pharma giant blows whistle on own drug, eyeforpharma, 10 January 2013).
The decision to suspend the drug is backed up by a recommendation from the EMA’s Pharmacovigilance Risk Assessment Committee after reviewing the drug’s trial results. As far as the other countries are concerned where Tredaptive is still available, Merck & Co is working with the regulatory agencies to communicate the decision to healthcare providers, with the timing to be based on individual country regulations and processes.
In the meantime Merck recommends that physicians stop prescribing the drug as well as that they review treatment plans to discontinue the drug and consider alternative means of therapy.
Michael Rosenblatt MD, Merck’s chief medical officer had this to say, “Patients currently taking Tredaptive are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure the physicians have appropriate information as we take steps to suspend the availability of Tredaptive.”
DID YOU KNOW?
- The study was independently conducted by the Clinical Trial Service Unit at Oxford University and funded by Merck.
- The study enrolled 25,673 patients considered to be at high risk for cardiovascular events. Of those enrolled, 14,741 were from Europe (the United Kingdom and Scandinavia) and 10,932 were from China.
- The major vascular events referred to include: coronary deaths, strokes, non-fatal heart attacks, strokes and revascularisations.
- The adverse side-effects events referred to fall in the following categories: blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin.