Fen Phen and Heart Valve Leaks

If you took the diet pill Fen Phen during the 1990s, your heart troubles may have been caused by this diet pill.

What is the problem with Fen Phen?

Fen Phen is a diet pill that millions of people used for quick and effective weight-loss. They reached maximum popularity between 1995 and 1997. In 1997, the U.S. Food and Drug Administration (FDA) banned the sale of Fen Phen and other diet pills that contained fenfluramine due to reports of heart valve damage, lung blood vessel damage, Primary Pulmonary Hypertension, Pulmonary Arterial Hypertension, and cardiac fibrosis.

Fen Phen and other diet pills contained fenfluramine, a drug that makes a person’s brain release excess serotonin, which makes people feel good, full, satisfied, and less likely to eat food. Fenfluramine had been around since the 1970s (as Pondimin), but never became very popular as a diet pill, because it made people feel drowsy. When a doctor suggested combining fenfluramine with Phentermine, a stimulant drug, Fen Phen was born and the diet craze began to gain momentum. Doctors started prescribing it “off-label” for quick weight-loss without diet or exercise.

Because the patent on Fen Phen was set to expire just as the craze took off, the drug-makers quickly created another diet pill: Redux. Redux contained a derivative of fenfluramine, dexfenfluramine, which had all the negative side effects of the original drug. As diet drugs gained more and more attention, a study of the fenfluramine was published in Europe that linked it to Pulmonary Arterial Hypertension (PAH), a serious, life-threatening, and permanent disease that causes damage to a person’s heart and lungs.

In spite of the safety information, demand for the diet pills was high. The FDA approved Redux in 1996. The pharmaceutical company producing Redux and Fen Phen spent $52 million promoting the products, including paying for articles in women’s magazines. In 1996, sales hit $300 million. More than 18 million prescriptions were filled.

The wild success of the diet pills would not last. Doctors began notifying the FDA that they were receiving more and more patients with unusual heart valve damage, and they all had something in common: they were taking a diet pill that contained fenfluramine.

The FDA received 75 reports of diet pill induced injuries, and in September 15, 1997, they abruptly ordered that the drugs be banned in the United States. Unfortunately, by this time, millions of people had been exposed to fenfluramine. Thousands suffered permanent heart damage. Some died. Later studies would show that even people who had only taken diet pills for a few weeks showed signs of injury.

Many people who took Fen Phen, Redux, or Pondimin were not immediately diagnosed with heart valve damage or other heart troubles. Sometimes these problems do not show symptoms right away, so people are not diagnosed until many years after they took the pills.

What is a heart valve leak?

A normal heart has four chambers, and when the heart pumps blood through these chambers, the blood passes through valves that only let the blood move in one direction. These four valves are called the tricuspid valve, pulmonary valve, mitral valve, and aortic valve. The part of the valve that opens and closes consists of two or three delicate flaps. Fenfluramine can cause damage to these delicate flaps, which prevents them from sealing properly when the heart pumps.

As a result, blood may leak backward through the valve, in a condition known as valve regurgitation. The severity of the problem depends on how much blood is leaking backward through the valve. People who have small leaks may never notice symptoms or even be diagnosed with a problem. In moderate or severe cases, however, the backward leaking can prevent blood from flowing through the heart. The initial symptoms may be mild, but they can be indications that a far more serious problem will develop over time. Heart valve leaks can lead to congestive heart failure and death.

Symptoms of Heart Valve Leaks

• Shortness of breath, especially during activity, but maybe also when you are resting
• Chest pain
• Easy fatigue
• Light-headedness
• Rapid heart rate
• Heart flutter, palpitations
• Dizziness

Heart Valve Leaks and Congestive Heart Failure

When blood is leaking backward through the heart, the heart must work much harder than usual to force blood forward against the leak. Over time, the heart muscle enlarges, like any muscle in the body. Unfortunately, it also stiffens. The heart muscle must remain flexible to pump effectively. A thick, stiff heart muscle can weaken suddenly, causing congestive heart failure and death.

Sometimes, people who have leaky heart valves decide to undergo surgery to repair the valve. Valve repair comes with its own set of complications and difficulties, especially because open heart surgery is very serious. People who suffer from leaking heart valves must often make a difficult decision: whether to undergo surgery, or whether to wait and see whether the leak starts causing heart enlargement.

Injuries Linked to Fen Phen

• Primary Pulmonary Hypertension (PPH)
• Pulmonary Arterial Hypertension (PAH)
• Heart valve damage
• Leaky heart valve
• Irregular heartbeat
• Heart murmur
• Damage to blood vessels in the lungs
• Heart failure
• Death