Thalidomide episode

Because of the painful thalidomide episode, long and costly tests are now carried out to study the possible secondary effects of pharmaceutically active substances. A great number of drugs that today save many lives would not have been available had they needed to go through the long periods of tests that are now required by legislation. 

Of 50 patients with multiple myeloma, 14 developed a deep venous thrombosis after taking thalidomide 400 mg/day, compared with two of 50 patients who did not take it (24) All the episodes occurred during the first 3 cycles of therapy. One patient taking thalidomide had a pulmonary embolus. Most of the patients continued to take thalidomide with the addition of low molecular weight heparin followed by warfarin and there was no progression of deep venous thrombosis. 

The risk of thrombosis from thalidomide may be increased in certain conditions, such as malignancies, cicatricial pemphigoid (29), and systemic lupus erythematosus. Four episodes of thrombosis (two arterial, two venous) occurred in three patients with systemic lupus erythematosus and one with severe atopic dermatitis within 10 weeks of starting treatment with thahdomide 50-100 mg/day (30). All four had at least one risk factor for thrombosis, but none had thrombosis before or after treatment with thahdomide. 

A 50-year-old man with history of chronic hepatitis B had transient rises in serum transaminases after two successive episodes of autologous stem cell transplantation, with spontaneous resolution at that time PCR for hepatitis B virus was negative (76). Later he was given thalidomide and after 5 months suddenly experienced dizziness and jaundice. The concentration of hepatitis B virus DNA was 1641 pg/ml and serological tests for other viruses were negative. Despite conventional supportive care, he died of septicemic shock caused by Klebsiella pneumonia. Other hepatotoxic agents were excluded. 

The years since 1935 have seen the rise of the pharmaceutical industry to its present eminence. Despite the thalidomide disaster and a handful of other tragic episodes, the industry has flourished. A formulary of life-saving and life-improving drugs has been discovered. Two questions are now paramount. First, can society go on spending ever more of its national product on health care and, second, can the momentum be maintained Have all the easy illnesses been dealt with so that only the difficult ones are left ... 

Drug-related epidemics have occurred, mercifully relatively infrequently. However, with each unfortunate episode, there is inevitably a variety of regulatory and clinical fallout. Indeed, the illnesses associated with ingestion of glycol-tainted linctus led to the Food, Drugs and Cosmetics ( ) Act in the USA, and the disastrous association of phocomelia with thalidomide propelled reforms of drug regulations worldwide. Other famous examples include, of course, practolol-induced ocu-lomucocutaneous syndrome, and, more recently, fenfluramine-induced myocardial fibrosis, and isotretinoin-associated birth defects. 

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