PPH linked to Fen Phen before Drug was Approved

Madison, NJSince American Home Products announced that its diet drug combination fen phen was being pulled from the market, thousands of lawsuits have been filed against the drug maker. Eleven thousand lawsuits that were settled by American Home Products cost the company $4.83 billion. Lawsuits that were filed claimed that fen phen caused the diet drug users to suffer from primary pulmonary hypertension (PPH), valvular heart disease, endocardial fibrosis, and in many cases those conditions resulted in death.

Fen phen was recalled in 1997 after two studies both found serious negative side effects related to the use of fen phen. The first study, published in the New England Journal of Medicine in August 1996, showed that people who took fen phen for three months or longer had PPH at a rate 23 times that of people who did not take fen phen. The second study, conducted by the Mayo Clinic and released in 1997, showed that fen phen was linked to a risk of heart valve problems.

However, despite fen phen being off the market for ten years, people who took it are still at a risk of developing PPH. This is because PPH can take years to develop and can also take a long time to diagnose.

According to an article in the Washington Post, Dr. Leo Lutwak, who was lead FDA medical officer reviewing Redux, expressed concerns about the safety of fen phen after helping to evaluate clinical data on the drug. However, even though he sounded the alarm about fen phen, the drug was still approved by the FDA in 1996. In an interview with the Los Angeles Times, Lutwak recounted his concerns about Redux (half of the fen phen combination). "I, as the primary reviewer, felt that the drug had low effectiveness and very high risk for neurotoxicity and pulmonary hypertension," Lutwak said. He went on to say that he insisted that the drug come with a black box warning, but the manufacturer resisted the warning and the FDA sided with the company.

In a different interview, this time with Frontline, Lutwak said that when the drug was approved, he became concerned about the role the drug company was playing the approval process and he was very worried about the effects the drug would have on the thousands of people who would be using fen phen. He reported that when he looked at cases of PPH in people taking Redux he felt that there was too high an incidence of the condition; however the company told him that it did not occur often enough to make PPH a serious concern. Despite evidence to the contrary, the FDA decided that the benefits of fen phen outweighed the risks and the organization voted to approve it. That decision has left many people with PPH and heart valve problems.

Primary Pulmonary Hypertension (also Persistent Pulmonary Hypertension) is a very serious condition for which there is no known cure. Patients with PPH sometimes require heart-lung transplants and various types of medication. However, PPH can result in death, generally around three years after diagnosis although recent medical developments may have increased the life expectancy of someone with PPH.

People who developed PPH after taking fen phen are eligible to seek compensation for their losses. Those losses can include loss of income, medical expenses, and pain and suffering. Both individual and class action lawsuits have been filed against American Home Products (now called Wyeth). The company has increased reserves set aside to cover settlements related to fen phen four times since it was pulled from the market.