One of the problems associated with the Fen-Phen drug was primary pulmonary hypertension, a heart and lung related condition. The product was pulled from the market for heart risks and other side effects. But now we have another combination that could also foster cardiovascular risks such as increased heart rate, and other side effects.
In fact, according to an ABC News report (7/17/12), the US Food and Drug Administration (FDA) initially issued a big thumbs-down to the Topiramate-Phentermine combo in 2010 out of concern for serious side effects. But the expert panel, in the end, did an about-face and recommended approval of the drug two years later in a vote that could only be described as an overwhelming majority. Their reason? There wasn’t anything on the market that could really help severely obese people, for whom traditional efforts involving diet and exercise alone don’t seem to work. Thus, severe obesity is, in itself a health risk. Other factors such as heart disease and diabetes complicates obesity, and the panel felt the new diet drug containing one-half of the drug contained in the original Fen-Phen pills, would carry less risk even in view of side effects, when offset against the risks to a person’s health of severe obesity.
The Fen-Phen of today, so to speak, is the weight-loss drug Qsymia. Originally dubbed Qnexa, ABC News reports that the FDA required manufacturer Vivus to alter the name to avoid confusion with similarly-named drugs. Qsymia, apparently, takes advantage of the tendency of Topiramate to result in weight loss as a side effect, and the capacity of Phentermine to suppress appetite. Overweight Americans who have used Qsymia have said they are less hungry, and food tastes different--enough to foster a desire to eat less. The manufacturer says the new drug must be used in concert with a healthy diet and exercise.
But there are similarities with the Fen-Phen of old. There are risks for elevated heart rate in certain patients, and pregnant women are decidedly off-limits, due to concern for birth defects. According to Dr. Richard Besser, the Chief Health and Medical Officer for ABC and commenting on Good Morning America in July of last year, women interested in going on Qsymia have to medically ensure they are not pregnant at the time they start on the drug, and that monthly pregnancy tests are required while the Qsymia regimen is active and ongoing.
Because Phentermine was part of the Fen-Phen diet pill, the FDA is requiring the manufacturer of Qsymia to undertake long-term studies to watch for heart problems.
Dr. David Katz, director of the Yale Prevention Research Center, referenced Qsymia as useful over the interim. “It will help some people lose weight, and many others will try it, dislike it and stop, and gain the weight back.”
But he also said this:
“Honestly, I won’t be surprised if adverse effects over time result in a reversal of the approval,” for Qsymia, Dr. Katz told ABC.
READ MORE PPH AND FEN-PHEN LEGAL NEWS
The manufacturer of the original Fen-Phen drug was American Home Products, which later became Wyeth, according to The Philadelphia Business Journal (1/8/13). Wyeth was later swallowed up by Pfizer. The Fen-Phen diet pill was pulled off the market in 1997 due to PPH and Fen-Phen, and heart valve problems. Health advocates are watching Qsymia--the combination of Topiramate and Phentermine--to see if there could be similar concerns emerging beyond the capacity for confusion, and an elevated heart rate.