Quoted from http://www.reuters.com/article/idUSN3013842020100630
US FDA probes possible risks of Lilly drug, othersWed Jun 30, 2010 6:02pm EDT
WASHINGTON June 30 (Reuters) - U.S. health officials have launched probes into possible risks from an Eli Lilly and Co (LLY.N) bloodthinner, a Sanofi-Aventis (SASY.PA) heart drug and other medicines.
The Food and Drug Administration released its quarterly list of early investigations into health problems reported with various drugs on Wednesday.
On the list, the agency said it was probing cases of thrombotic thrombocytopenic purpura (TTP) in patients treated with Effient, a blood thinner from Lilly and Daiichi Sankyo (4568.T). TTP is a rare but potentially fatal blood disorder.
Effient's makers have seen one, or "possibly two," reports of TTP with the drug since its approval a year ago, Lilly spokeswoman Tammy Hull said. No cases were recorded in clinical trials, she said.
"Daiichi Sankyo and Lilly are working with the FDA to update the label," Hull said.
The current prescribing instructions for Effient, a potential blockbuster, note that TTP has been reported with other blood thinners.
For Sanofi's drug Multaq, approved for treating an irregular heartbeat, the FDA said it was looking at reports of congestive heart failure. A company spokeswoman had no immediate comment.
The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The list released on Wednesday covered issues identified between January and March 2010.
Being on the list does not mean the FDA has concluded the drug causes the specific risk, the agency said.
Cubist Pharmaceuticals Inc (CBST.O) spokeswoman Eileen McIntyre said the FDA told the company in March it was evaluating reports of a type of pneumonia with the company's antibiotic Cubicin, one of the issues on the list.
The problem already is mentioned in the drug's prescribing instructions as a known reaction to Cubicin, McIntyre said. The two reported cases resolved when Cubicin was stopped, she said.
The safety probe list was posted on the FDA website here