Last week, Sanofi recalled four batches of well known painkiller Combiflam on the grounds that the disintegration time of those tablets was delayed. It was a Class III recall, which implies that the risk is relatively low; consuming such a drug is unlikely to affect the health adversely. The world over, though, there have been many cases of drugs being banned or recalled after great damage has been done.

Thalidomide has the sombre reputation of catalysing drug reforms in many countries. Made by a German company and sold first in 1957, it was marketed as a sedative mild enough even for pregnant women. An off-label use was to prevent morning sickness. Its popularity spread and it was being used in 46 countries by 1960.

However, it was soon held responsible for the birth of children with shortened limbs, and by early 1962, banned in most of the countries sold. However, it came back to some markets where it was found to be safe and effective for treatment of leprosy and myelomas. Thalidomide compensation across countries has run into several billion.

Fen-phen was a drug where settlements and damages reportedly amounted to $21 billion. A popular weight loss solution, it was recalled in 1997 after 27 years of being in the market.

Users complained after they began experiencing heart disease and pulmonary problems. American Home Products (later Wyeth) sold the combination of fenfluramine and phentermine under the brand name of Pondimin and also made Redux, a similar drug.

Diethylstilbestrol (DES) was a hormone prescribed for more than 30 years to prevent miscarriages and other complications during pregnancy. In 1971, it was connected to a tumour that occurred in the daughters of women who had used it.

It was made by several manufacturers and recalled in 1975 in the US. The damages paid are difficult to quantify as each maker paid amounts correlated to their market share.

In 2004, Merck had to recall Vioxx (Rofecoxib) after five years of being in the market. It was prescribed as a pain reliever for arthritis but was found responsible for heart attacks and strokes. The company and FDA came in for severe criticism for ignoring its dangers.

Merck reportedly settled the litigation in the US for $4.8 billion, and spent nearly $1 billion in legal expenses.

Compiled by Sravanthi Challapalli

comment COMMENT NOW