Barcelona, Asunción, La Paz, Rio de Janeiro, October 5, 2011 – Thousands of people with Chagas disease will go untreated in the coming months due to a shortage of benznidazole, the first-line drug used in most endemic countries. Just as a number of countries are actively seeking to reverse the long neglect of Chagas disease, the supply of the most commonly used treatment threatens to run out.
The humanitarian medical organisation Médecins Sans Frontières (MSF) is urging the Brazilian Ministry of Health, which is responsible for the only laboratory in the world manufacturing benznidazole, to respect its commitment to Chagas patients and take immediate measures to make the drug available.
The Brazilian state laboratory LAFEPE (Laboratorio Farmaceutico do Estado de Pernambuco) is currently the only pharmaceutical company producing benznidazole tablets. Responsibility for producing the active pharmaceutical ingredient, API, was recently transferred to a private company, Nortec Química. Right now, there is not enough API available for LAFEPE to produce the tablets needed, and Nortec has yet to validate API production. In addition, LAFEPE has breached its promise to publish and fulfil a manufacturing schedule that would ensure availability of the drug.
As a result, a number of national Chagas programmes in Latin America are already struggling to meet the demand for new treatment and are expected to run out of stock in the next few months. No information has been provided by the Brazilian Ministry of Health on what is happening.
Neither the World Health Organization (WHO) nor the Pan American Health Organization (PAHO) have put a contingency plan in place to maintain stocks of benznidazole for acute cases of Chagas. The future availability of the drug is not known, although it has been estimated that more drugs are unlikely to be available before mid-2012.
“This situation is unacceptable. In Boquerón, an area with one of the highest rates of Chagas in Paraguay, we are forced to stop diagnosing patients because we simply don’t have the drugs to treat them,” explains Dr Henry Rodríguez, MSF’s head of mission in Bolivia and Paraguay. “For decades Chagas was a completely neglected disease and just when diagnosis and treatment were finally being made a priority, we’ve run out of medication. We must not allow this to continue; an urgent solution must be found for our patients.”
Demand for treatment has increased significantly in recent years because adults are now being treated as well as children, and the WHO and the PAHO have strongly endorsed diagnosis and treatment at the primary healthcare level. However, the progress made so far is being jeopardised by the shortage of benznidazole. “Although we know that current treatment is more effective and more likely to prevent complications the sooner a patient is treated, we will be forced to delay it,” says Dr Unni Karunakara, MSF's international president.
MSF has called upon the Brazilian Ministry of Health to commit to speeding up the current benznidazole manufacturing process by streamlining the drug’s validation with validation of the API produced by Nortec. Given that the production, distribution and sales process will take several months, Brazil must spearhead a regional contingency plan – with the support of the PAHO – for the rational use of existing benznidazole stocks among the most vulnerable groups in endemic countries. MSF is also urging the Ministries of Health of endemic countries to demand that this contingency plan is put in place as soon as possible, while finding a definitive solution for the long term.
“The Brazilian government has been pioneering in the production of generic drugs, showing its commitment to people who need access to treatment. It must now act swiftly to maintain its commitment to Chagas patients worldwide,” concludes Dr Karunakara.
About Chagas disease
Download full Chagas fact sheet (pdf)
Chagas disease, also known as human American trypanosomiasis, is an infectious disease caused by the parasite Trypanosoma cruzi. Endemic in several Latin American countries, it is estimated that 8 to 10 million people have Chagas, and that it causes 12,500 deaths per year and. Case numbers are rising in the US, Europe, Australia and Japan as a result of greater international travel.
In most Latin American countries the disease is primarily transmitted by the assassin bug, although it can also be transmitted from mother to child via blood transfusions, organ transplants, contaminated food and laboratory accidents. Because the infection is usually asymptomatic, most patients are unaware that they have it.
However, as the disease progresses, around 30 per cent of infected people will develop potentially fatal heart lesions and 10 per cent will develop gastrointestinal damage.
Until recently, treatment was thought only to be effective in the acute stage (up to three months after being infected) and very early in the chronic stage. However, studies have now shown that treatment can also be effective in the chronic stage. It has also been found in recent years that the side effects of the drug, which are more common in adults, are manageable and that under supervision, treatment is feasible in primary healthcare.