The Return of Fen-Phen Pills

 Posted on January 09, 2015 in Defective Drugs & Treatments

The product first hailed as a miracle weight-loss drug and subsequently pulled from the market when its dangers became apparent has resurfaced, albeit in another format. But the new drug has some of the same health concerns, and some new ones as well.

Fen-Phen

Fenfluramine was first introduced in the 1970s. Those who took it saw little or no results, so sales were quite weak until the early 1990s when it was combined with Phentermine. Its newfound success was short lived, however, as serious concerns about the link between Fen-Phen and primary pulmonary hypertension (PPH), one of the most serious heart-lung disorders, began to surface in the mid to late 1990s. The Food and Drug Administration recalled Fen-Phen in September 1997.

Qsymia

Fenfluramine was considered the more dangerous of the two drugs. Several years after the Fen-Phen recall, Vivus introduced a new drug pairing Phentermine with the anti-seizure drug Topiramate. The new anti-obesity drug, then known as Qnexa, initially faced some obstacles at the FDA because of its questionable heritage. But the agency eventually approved the drug for treatment of dangerously obese patients.

Possible Side Effects

To date, the FDA has only approved Qsymia for use in adults with a body mass index (BMI) over 30, or with a BMI over 27 if the patient also suffers from at least one weight-related condition, such as hypertension or Type 2 Diabetes.

One lingering concern is that PPH patients may not be symptomatic right away. They may seem fine, even to an examining physician, but are already developing heart valve problems. Other side effects may include:

• Elevated Heart Rate: Some patients report a pounding heart rate or a fluttering in their chests. Many weight-loss drugs are essentially stimulants, so this effect is unsurprising.
• Memory Problems: Other patients report dementia-type symptoms, such as memory loss, fuzziness, irritability and even depression.
• Birth Defects: Pregnant women should not take Qsymia, and women taking the drug should have monthly pregnancy tests to confirm they are not pregnant.

One prominent observer predicted that these side effects, coupled with the specter of PPH, may eventually cause the FDA to revisit Qsymia's approval and perhaps even recall the drug altogether.

If you or a loved one were injured by any prescription or nonprescription drug, contact our Arlington Heights defective medical products attorneys for a free phone consultation. We have four office locations in the northern Illinois community.