Maha FDA recalls TB drug after spotting wrong dosage

Written By: Admin | Published : November 13, 2013 3:02 PM IST

Recently, the Mumbai Mirror reported that strips of pharma major Sandoz's TB combination drug 4D sold across six states had the wrong dosage. Later on FDA inspectors found that even a more potent version of the TB drug called 4D Plus also had the wrong dosage. The FDA asked its inspector to suspend the sale of drugs 4D and 4D Plus in the state and also alert the other states where the drug is marketed.

A south Mumbai doc had written to Maha FDA after spotting the mixed-up dosage in some strips that one of his patients had bought from a pharmacy in Cumballa Hill. The patient had consumed five such strips and fell violently ill with bouts of vomiting. Each strip of 4D is supposed to have the following drugs:

One red tablet which is supposed to be a combination of Rifampicin and Isoniazid (red colour)
Two tablets of Pyrazinamide (white)
One tablet of Ethambutol (white)

The patient's strips had two red tablets.

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Why wrong dosages are dangerous

The danger of wrong dosages is multi-fold. First and foremost, it makes the drugs ineffective. Often, the wrong line of treatment, discontinued course of medicines and inappropriate dosages are the main reasons for the TB bacterium developing great resistance to antibiotics and the rise of cases of drug-resistant TB. TB claims two lives every three minutes in India.

What is tuberculosis?

Tuberculosis is a common infectious disease caused by bacteria called mycobacterium tuberculosis which affects the lungs. Main symptoms of TB are severe cough that lasts for three weeks or longer, bloody or discoloured sputum, night sweats, fever, fatigue and weakness, pain in the chest, loss of appetite, and pain during breathing or coughing. India had the highest total number of TB cases worldwide in 2010 partly due to poor disease management by the private healthcare sector. TB can be prevented by vaccination and maintaining high levels of hygiene. One infected, the patient should follow the medication regimen properly. By not doing so, there are chances of developing resistance to anti-TB drugs resulting in an aggressive form of TB called MDR-TB (multi-drug resistant TB).

What is MDR TB?

MDR TB refers to Multi-Drug-Resistant Tuberculosis. It is a type of tuberculosis that is resistant to the first line anti-TB drugs. It is often caused because people stopping their medication midway instead of following the complete regimen as prescribed by the physician. It is spread in the same manner as tuberculosis.

What are its symptoms?

Symptoms are same as regular TB and include severe cough which lasts for three weeks or longer, producing bloody or discoloured sputum, night sweats, fever, fatigue and weakness, pain in the chest, loss of appetite, and pain in breathing or coughing. However, in these cases, the symptoms progressively get worse and may cause complications and death since the patient does not respond to most anti TB drugs. (Read: How India's faring in the battle against TB)

How TB is caused?

TB is caused by the bacteria Mycobacterium tuberculosis. It is an aerobic (requires high levels of oxygen to survive), non-motile bacterium and transmitted primarily through the air. You can get TB from an infected person when he coughs, sneezes or spits. This bacterium is known to be highly stable and can survive in a dry atmosphere for weeks. A test known as 'drug sensitivity' is performed on a TB strain to determine which drug will eradicate the bacterium most effectively.

How did the bacteria develop to become drug resistant?

When the disease first emerged it was treated with a combination of drugs. With time, the bacterium started to develop immunity to the drugs being used. As the bacterium mutated, medical science started to use more potent drugs for its treatment. This cycle resulted in the formation of a strain that is so evolved that it is immune to all medications known to treat the disease. (Read more: Drug-resistant tuberculosis why you should be worried)

How can you prevent tuberculosis?

Avoid close contact with people affected with TB. If you cannot avoid contact with them, wear protective masks and gloves. If you work at a hospital, wear good-quality microfilteration masks. Wash your hands with a disinfectant cleanser after contact with the patient.
Avoid crowded, stuffy and unhygienic places.
Work on improving your immunity by including diet rich in antioxidants. Have at least 4-5 servings of fresh vegetables and fruits every day. If you cannot have it due to certain practical constraints, make sure you take your daily dose of antioxidants/multivitamins after consulting your doctor. Anti-oxidants help fight free radicals produced in the body due to any kind of disease/stress and help in cell repair.
Include at least 2 good servings of protein in your daily diet. They are the building blocks of all our cells and help in cell repair too. (Read more: How you can prevent tuberculosis)

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