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HEALTH-PANAMA: Industrial Solvent Identified as Cause of 22 Deaths

María Mercedes de la Guardia

PANAMA CITY, Oct 17 2006 (IPS) - A tainted generic cough syrup has been identified as the culprit in a rash of mysterious deaths in Panama. The toxic ingredient, diethylene glycol, is well known for its harmful effects. Was this an error? Was it deliberate? No one knows yet.

Authorities confirmed Tuesday that diethylene glycol, an industrial solvent and antifreeze prohibited for medicinal use, was present in the cough syrup, as well as in other medicines and even a lotion, all manufactured by the laboratory belonging to the state Social Security Fund (CSS).

Of the 51 people who have fallen ill, 22 have died of kidney failure.

Since September patients have been trickling in to public hospitals complaining of nausea, vomiting, diarrhoea and general weakness of the limbs, progressing to the point where they were unable to pass water. On Oct. 1, the authorities met to study the situation.

On Oct. 3, the Ministry of Health and CSS announced that “the national system of epidemiological surveillance had detected an unusual increase in the number of cases of acute renal insufficiency.” The patients were mostly over 60, with a history of high blood pressure, diabetes and kidney problems.

Fearing an outbreak of a contagious disease, the Pan American Health Organisation and U.S. Centres for Disease Control and Prevention (CDC) were asked for help. A local interdisciplinary team of doctors was formed to supervise patient treatment.

Panama’s Gorgas Memorial Institute joined the investigation effort, and carried out tests for dengue, influenza A and B, West Nile virus, equine encephalitis and enterovirus, all of which proved negative.

“Our concern was that it might be an emerging infectious disease that could spread rapidly through the population. But when we put all the pieces together we saw that they didn’t match this picture. Some patients lived in houses where there were up to 10 children, all crowded together, and only one person was affected. Doctors and nurses who were treating the patients were not infected either,” Dr. Jorge Motta, director of the Gorgas Institute, told IPS.

Investigators then started looking for a toxin that might have caused the disease. “When we looked at the medicines the patients were taking and those they told us about, we found 35 percent were on lisinopril,” Motta said.

On Oct. 7, without having established direct causation, the Ministry of Health withdrew lisinopril, a prescription drug for high blood pressure, from the market. Then it transpired that some patients were taking up to 18 different medicines, which opened up a vast number of possibilities. Samples of the medicines were sent to CDC, and the first one tested was lisinopril, in which no anomalies were found.

The second batch of samples tested was from cough syrup found in the medicine cabinets of some of the patients. Four of the bottles contained diethylene glycol, which has now been confirmed as the toxic substance.

On Thursday Oct. 12, the Ministry of Health and CSS directed the population not to take the sugar-free cough syrup in 120 millilitre bottles which is made by CSS’s own laboratory. The product was withdrawn and the arrival of an antidote, known as fomepizole, was announced.

Diethylene glycol has quite a long history of poisonings.

The first known case was reported in the United States in 1937, when a shipment of sulphanilamide elixir made with diethylene glycol caused the death of 107 people, including many children. Toxicity tests had not been performed on the medicine. In response, the U.S. government enacted the federal Food, Drug and Cosmetic Act of 1938.

In 1969, seven children died in South Africa after taking contaminated sedatives, and four people died in the Sahara desert after drinking water from a container in which there were traces of diethylene glycol.

In Austria in 1985, wines adulterated with diethylene glycol, added as a sweetener, were discovered. The following year, in India, 14 people died after receiving doses of glycerine contaminated with the solvent. Between 1990 and 1992, some 200 people died, out of 300 who were affected in Bangladesh, after taking an elixir containing the poisonous substance.

In Argentina, in 1992, 25 people died after taking a tonic contaminated with diethylene glycol. From 1995 to 1996, 89 children lost their lives in Haiti, after taking acetaminophen in which the sweet syrup base contained diethylene glycol. In 1998, 33 children in India died after being given medicines containing the industrial solvent.

In Panama, investigators are trying to determine how the diethylene glycol reached the CSS laboratories. “The theory that there was criminal intent is highly unlikely. Some glycols are used in manufacturing medicines, but diethylene glycol isn’t one of them. It’s a poison,” said paediatrician Pedro Vargas.

“The other hypothesis is that diethylene glycol, which is colourless and odourless, might have been mistaken for glycerine or propylene glycol,” he said.

Motta agrees with the second theory: “The most likely explanation is contamination or mistaken substitution of an ingredient. I refuse to believe that this was a premeditated act.”

A specialist in childhood infections, Xavier Sáez-Llorens, is also inclined to think that “the raw materials brought in from outside (glycerine, for instance) may have been contaminated by the toxic substance, as happened in Haiti in 1995-1996. I don’t think that there was a criminal hand in this, nor that the contamination happened in the CSS laboratory, where basically the ingredients are just mixed,” he said.

There is another remote possibility: the syrup may have been contaminated during the production process.

Even if it is proven that the ingredients were already contaminated before they were mixed together in the CSS lab, Panamanian authorities will not be off the hook. “A woman who walked into the hospital with pneumonia was given this syrup as part of her treatment. Now she is dead. Under the rule of law, someone must be held accountable,” said Motta.

The crisis has highlighted failings in public health centres and at the laboratory where pharmaceutical products are prepared and distributed to users of the social security system’s health facilities.

It is now known that the University of Panama’s Institute of Specialised Analysis has not inspected medicines produced by the CSS since 2002.

Meanwhile, 10 people are still in intensive care. One of them, Enedina Saavedra, 79, was admitted to the San Judas Tadeo hospital in Panama City on Sep. 29, with a cold.

On Oct. 3, her family was told that she had not passed water for 24 hours, and that she would be transferred to a specialised clinic belonging to the CSS. “There were no beds,” her grandson Antonio Araúz said, “so they laid her on a stretcher.”

“They put her on dialysis, and right away she lost her sight. The doctors said it was cataracts, but my grandmother never even wore glasses.” In his opinion, “they gave her the syrup in San Judas Tadeo,” although the hospital director there has not given him the list of medicines prescribed for Saavedra.

The fomepizole antidote is unlikely to work in her case. She has been on a ventilator since Oct. 9. “Her neurological and renal systems are damaged,” said Araúz, adding, “I have no tears left to shed for my grandmother.”