After Heparin: - The Pew Charitable Trusts

PHARMACEUTICAL MANUFACTURING: GLOBALIZATION AND QUALITY MANAGEMENT
Case study 5
Lethal cough syrup in Panama
In Panama in 2006, cough medicine that had been manufactured using a toxic syrup originating in
China was unknowingly distributed by the government. 228 The official number of deaths was 78, 229
but unofficial reports suggest the possibility of a much larger toll. 230
The Taixing Glycerin Factory in Hengxiang, China labeled barrels of diethylene glycol (DEG), an
industrial solvent often used in antifreeze formulations, as glycerin, a common excipient (inactive
ingredient) used to make medicines into syrups. 231,232 DEG is chemically similar to glycerin, but it is
less expensive to make. 233 The material passed through brokers in China and Spain, being relabeled
at each step, before finally reaching Panama. 234,235 In 2006, the Panamanian government purchased
the material and used it to manufacture an estimated 60,000 units of medicines, which were distributed
to patients. 236
When patients began to suffer paralysis and die, medical personnel could not determine the cause
until more than a month after the adulterated medicine was distributed. Even when the substitution
of DEG for glycerin was discovered, relabeling by brokers prevented officials from quickly identifying
the source. Each time the fake glycerin changed hands, an international broker created new
certificates of analysis indicating identity and purity, presumably without independently testing the
product. Obfuscation of records impairs investigations of this sort of deception and shields bad actors
from identification and prosecution. As of early 2011, no one in China has been held accountable
for the deaths in Panama.
This was not the first DEG poisoning. Indeed, the use of DEG to manufacture Elixir Sulfanilamide (a
liquid antibiotic) in the United States in 1937 caused more than 100 deaths and led directly to the
enactment of the Federal Food, Drug, and Cosmetic Act. 237 Between 1937 and 2008, there were
more than 750 documented deaths in 10 countries associated with exposure to drugs contaminated
with DEG. 238 The largest loss involved the deaths of 236 children in Bangladesh between 1990 and
1992. 239 According to an investigation by the New York Times, 50 tons of fake glycerin shipped to
the United States in 1995 were fortunately identified. 240 But in 1997, at least 88 children in Haiti
were reportedly killed by this adulterant, 241 which was also traced back to a Chinese manufacturer
and involved one or more brokers. 242 In 1998, DEG poisoning was implicated in the deaths of 33
children in Guragon, India. 243 After the disaster in Panama, the U.S. Food and Drug Administration
issued guidance that all glycerin used in drug manufacturing, including glycerin imported into the
United States, be tested for DEG. 244 The U.S. Pharmacopeia released a more stringent monograph
for glycerin with revised testing methods in 2009. 245
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 33