|Blood pressure drug called into question by Mass. grand jury. Source: Today’s Senior Network|
Biovail has been notified by the U.S. Attorney's Office in Boston that the company is the target of a federal grand jury investigation in connection with activities surrounding the 2003 commercial launch of Cardizem LA.
In particular, the investigation relates to the Cardizem LA clinical experience program, entitled PLACE (Proving LA through Clinical Experience).
The investigation could lead to possible civil or criminal charges against the company, according to the Toronto-based Biovail.
The investigators have requested that Biovail provide evidence and arguments related to the promotional and marketing activities for the drug’s launch to the U.S. Attorney's Office, which the company said it intends to do so as soon as practicable.
The FDA has indicated Cardizem LA for the treatment of hypertension and for the management of chronic stable angina.
Biovail reported that in the clinical trials of patients with high blood pressure, the most common side effects reported were lower-limb swelling, sinus congestion, and rash. In clinical trials of patients with chronic stable angina, the most common adverse events were lower-limb swelling, dizziness, fatigue, bradycardia and primary heart block, according to the company’s statement on its website.