Fen-Phen Update
Physicians who have prescribed the diet medications popularly known as "Fen-Phen" to their patients may have been asked about the drugs’ potential adverse effects upon the heart valves. Information and answers are available from three sources.
In November 1997, the U.S. Department of Health and Human Services (DHHS) issued a set of interim recommendations regarding follow-up of exposed patients. These recommendations are summarized in this bulletin, and the full text is available at the FDA Web site. The FDA site also includes background information, updates, and answers to questions about the DHHS interim recommendations. You may also consult the January 21, 1998 issue of JAMA for a detailed article on the subject.
Media publicity will certainly generate anxiety among patients, and the plaintiffs’ bar is already gearing up to generate multiple class action suits in which physicians might well be involved. Until a cause-and-effect relationship is established for these medications, taking an open, proactive approach with patients is probably the best way to help keep fear and misunderstanding to a minimum. It is important to allay anxiety and deter emotional distress by reminding patients that the vast majority of patients who took these medications will not suffer any consequences.
Summary of U.S. Department of Health and Human Services’ Recommendations for Patients Who Have Used Fenfluramine or Dexfenfluramine Medications
- Obtain a complete medical history and perform a cardiovascular examination.
- If the patient exhibits cardiopulmonary signs or symptoms suggestive of valvular disease, obtain an echocardiographic evaluation and refer for a cardiology consult, as indicated.
- Strongly consider performing echocardiography on all persons— regardless of signs or symptoms—who have been exposed to fenfluramine or dexfenfluramine before the patient undergoes any invasive procedure for which antimicrobial endocarditis prophylaxis is recommended by 1997 AHA guidelines.
The DHHS recommendations are not mandatory. They are intended for the use of physicians whose clinical judgment must be the most important factor in any ultimate decision of patient care.
