Thalidomide – Fen/Phen

 

 

Thalidomide:

 

Thalidomide was chiefly sold and prescribed during the late 1950s and 1960s to pregnant women, as an antiemetic (controlling vomiting and nausea) to combat morning sickness, as well as an aid to help them sleep. Unfortunately, this resulted in catastrophic results for many children of women who had taken thalidomide during their pregnancies.

 

From 1956 to 1962, approximately 10,000 children, mostly in Europe, were born with severe malformities, including phocomelia (shortened webbed arms or legs), because their mothers had taken thalidomide during pregnancy.   

 

Thalidomide was so powerful, that just one pill taken between the 25th and 36th day after conception resulted in horrible birth defects. The ironic thing about this drug is that it was extremely safe – except for pregnant women during their first trimester. Tragically – it was never thoroughly tested for this ghastly side effect.

 

 

Fen/Phen

 

Fen/phen was an anti-obesity medication, which consisted of two drugs: fenfluramine (“fen”) and phentermine (“phen”). After reports of valvular heart disease and pulmonary hypertension (primarily in women who had been taking fen-phen), the Food and Drug Administration (FDA) requested its withdrawal from the market in September 1997.

 

Approximately 30 percent of patients who were evaluated with a heart sound wave test (echocardiogram) had abnormal results, even though they had no prior symptoms.

 

In July 1997, researchers at the Mayo Clinic reported 24 cases of rare valvular disease in women who took the "fen-phen" combination therapy. The FDA alerted medical doctors it had received nine additional reports of the same type.

 

Subsequently, the FDA received 66 additional reports of heart valve disease associated mainly with "fen-phen." There were also reports of cases seen in patients taking only fenfluramine or dexfenfluramine (the “fen” part of Fen-phen).

 

As of 2004, fen-phen is no longer widely available. In April 2005, American Lawyer magazine ran a cover story on the fen-phen mass tort crisis and reported that more than 50,000 product liability lawsuits had been filed by alleged fen-phen victims. Estimates of total liability run as high as $14 billion.

 

The “phen” part (phenteramine), however, is still used extensively today and was never implicated in the heart or lung problems.