Is Herbal Fen-Phen Just as Bad as the Banned Fen-Phen?

Washington, DCFen-phen may have disappeared from store shelves back in 1997, but it hasn't disappeared entirely. Neither has PPH and Fen-phen—and Fen-phen side effects that cause primary pulmonary hypertension (PPH). The adverse health issue has fostered a number of PPH class action lawsuits.

That's because Fen-phen is still around as a herbal product and is reported to be still available in some health food stores. As such, it escapes regulation from the US Food and Drug Administration (FDA), which has no jurisdiction over herbal remedies in the same way it does over pharmaceuticals.

Unlike a prescription medication, which requires FDA approval before it is allowed on the market, herbal remedies do not require such approval.

Fen-phen was a diet product that combined fenluramine with phentermine. While the FDA maintains to this day that phentermine on its own is a safe and effective weight-loss agent, the particular combination of fenluramine and phentermine (the so-called fen-phen) was found to promote PPH, a disease of the lung that can often take years to appear even after fen-phen use has stopped.

Case in point: the late Rennee Tedesco, one of five women who sued Wyeth Pharmaceuticals in December 2006. The plaintiffs claimed in their lawsuit that Fen-phen caused them to develop the often-fatal lung disease years after they took it.

For Tedesco, who died earlier this spring at the age of 55, her relationship with Fen-phen amounted to about 90 days in 1997, not long before the popular diet product was recalled by the FDA. A decade later Tedesco, according to her obituary published May 1st of this year in the Bergen County Record was diagnosed with primary pulmonary hypertension in April of 2006 and underwent a double lung transplant 6 months later in October.

According to The Record all five women who sued Wyeth had taken Fen-phen between 1996 and 1997, and all five were diagnosed with PPH in 2005 and 2006.

Not long after banning Fen-phen from store shelves, the FDA was back with a white paper warning about the dangers of herbal Fen-phen.

On November 6th, 1997 the FDA began getting the word out about herbal fen-phen products that were being marketed through the Internet and weight loss clinics—among other locations—as a natural alternative to the prescription version of Fen-phen.

In an FDA talk paper posted on the official FDA web site, the federal drug regulator zeroes in on the ingredient ephedra, commonly known as Ma Huang. Ephedra is described in the FDA document as an amphetamine-like compound with potentially powerful stimulant effects on the nervous system and heart. The FDA indicated that it had received and investigated more than 800 reports of adverse events associated with the use of ephedrine alkaloid-containing products between 1994 and 1997. Those events
ranged from episodes of high blood pressure, heart rate irregularities, insomnia, nervousness, tremors and headaches to seizures, heart attacks, strokes and death.

The FDA at the time regarded any over-the-counter product commercially
promoted as an alternative to prescription anti-obesity drugs (such as phentermine and fenfluramine) to be a drug, and was taking appropriate regulatory action to remove such products from the market.

It should be noted that the FDA facilitated the ban of Ephedra in 2004 and the ban was upheld in 2006. Thus, it is now technically illegal to buy, or to sell Ephedra and any product that contains the banned ingredient. However, it is widely believed that it is still available in some health food stores.

Regardless of how easy it is, or isn't to find herbal fen-phen on store shelves, the proliferation of on-line pharmacies ensure such products are available by mail to whoever wants them.

Thus, the FDA is of the view that herbal fen-phen is not the safe alternative that manufacturers might allegedly claim it to be. While primary pulmonary hypertension may not be among the maladies specific to herbal fen-phen, Fen-phen-like side effects pose a worrisome possibility.