A

TRIPARANOL AND CHLORAMPHENICOL

Problems with Triparanol

In the same decade that thalidomide deformed thousands of babies around the world, more drugs were learned to have unexpected side effects. One was the Merrell's MER/29, or triparanol, marketed to lower blood cholesterol. The drug was found to cause baldness and blindness from an unusual form of cataracts. The FDA learned that these cataracts had been noted in animal studies required for approval of the drug, but Merrell failed to mention the finding to the FDA in the approval request. The FDA brought charges against Merrell, the parent company (Richardson-Merrell, Incorporated), and three former executives.

Antibiotic Risks of Chloramphenicol

Another drug with unexpected side effects was chloramphenicol, known by the trade name Chloromycetin (Parke, Davis and Company), an antibiotic particularly useful against some rare and tropical diseases and lifesaving against certain types of meningitis. When confined to the treatment of life-threatening infections, the risks of chloramphenicol are worth taking. Chloromycetin was introduced in 1949 with the hype given any new drug. Doctors prescribed it for minor bacterial infections, such as bronchitis and acne, and even as a placebo for viral infections such as colds—even though it was known that antibiotics have no effect on viruses. By 1952 some patients taking Chloromycetin were found to develop anemia, or low counts of red blood cells; the disorder was soon upgraded as aplastic anemia, in which the blood cells stop being made. Most people with aplastic anemia die from the disease, though male-hormone therapy, transfusions, and other hormones can save as many as 25 percent.

Accountability

A jury held that Parke, Davis acted irresponsibly in marketing the drug, in view of the fact that the link with aplastic anemia was known in 1952 and widely published in medical journals. In 1962 Carney Love, an aplasticanemia sufferer, was awarded over $300,000 from her doctor and Parke, Davis. She had been prescribed Chloromycetin for bleeding gums after a tooth was pulled, and again for bronchitis in 1958.

Dangerous but Useful

Still, in 1968, $70 million-80 million worth of Chloromycetin was prescribed to Americans, most of it for colds or acne. Of every sixty thousand patients receiving it, one died of aplastic anemia; for newborn babies, the severe anemia rate was over 50 percent. That year an FDA panel decided the drug should continue to be approved for use, since it could be lifesaving in treating some severe infections; but Parke, Davis was required to temper its advertising and send a warning letter to doctors about the drug's side effects.