CRF Blog

A tiny pharmacy is identifying big problems with common drugs

by Bill Hayes

The Washington Post reports that A tiny pharmacy is identifying big problems with common drugs, including Zantac.

The escalating global recall of Zantac, the heartburn pill that once ranked as the world’s best-selling drug, has its roots not in government oversight or a high-profile lawsuit, but in a tiny online pharmacy here whose founders feared that U.S. drugs might not be as safe as people think.

The pharmacy, Valisure, is a start-up with only 14 full-time employees. But since its scientists alerted American regulators that Zantac and its generic form, ranitidine, contained a chemical thought to cause cancer, more than 40 countries from Australia to Vietnam have either stopped sales, launched investigations or otherwise stepped in to protect consumers from possible health risks.

In the United States, the Food and Drug Administration this month confirmed unacceptable levels of the chemical, N-nitrosodimethylamine (NDMA), in some ranitidine products — including in some syrups taken by babies. FDA officials have urged people not to panic, because the levels of NDMA are similar to the amount found in grilled and smoked meats. The agency is still investigating and asking companies to recall ranitidine and a similar drug, nizatidine, if they discover unacceptable amounts of NDMA. The agency’s testing suggests Pepcid, Tagamet, Nexium, Prevacid and Prilosec do not contain the chemical. [more]