Drugs undergo rigorous testing before they are introduced into the market. They are first tested in animals and then in human beings during clinical trials. The efficacy as well as safety profiles of the drug are tested. In spite of this, some adverse effects of drugs appear only after the drug is used in the general population. These adverse effects are detected though a process of regular monitoring after the drug is released called pharmacovigilance. If the adverse effects are severe or the risks of using the drug outweigh the benefits, or if the drug is ineffective, the country may ban the drug or the Drug Company may itself voluntarily withdraw the drug. Some drugs may cause adverse effects only when combined with particular drugs. In such cases, only the fixed dose combination is banned and not the individual drugs.
A number of single drugs as well as fixed dose combinations have been banned for manufacture, marketing and distribution in India. Some drugs banned in India are mentioned below:
Fenfluramine and dexfenfluramine
Fenfluramine and dexfenfluramine were used to treat obesity. They were widely used in slimming centers. However, they were withdrawn due to reports of diseases of heart valves, fibrosis of the heart and pulmonary hypertension. The combination of fenfluramine and phenteramine, another weight loss pill was particularly notorious for causing heart valve problems and sudden death.
Rimonabant
Rimonabant was particularly effective in causing weight loss. It inhibited the action of substances called cannabinoids in the brain. It has been withdrawn due to serious side effects like depression, suicidal tendencies and seizures.
Sibutramine
Sibutramine is a weight loss pill that has been recently banned since it caused heart related side effects.
Astemizole and terfinadine
Astemizole and terfinadine are antihistamines that were used to treat allergies. They were banned since they could cause a heart condition called polymorphic ventricular tachycardia and even death when used in high doses or with drugs like erythromycin, clarithromycin and ketoconazole.
Phenformin
Phenformin is an antidiabetic drug similar to metformin. It has been banned since it carries a high risk of lactic acidosis.
Rofecoxib and valdecoxib
Rofecoxib and valdecoxib were popular painkillers that were used for arthritis and other painful conditions. They resulted in pain relief without causing gastric side effects. However, they were withdrawn due to concerns of heart attack and stroke with their use.
Rosiglitazone
Rosiglitazone is a drug used in the treatment of type 2 diabetes. It has been banned due to an increased risk of heart attacks.
Gatifloxacin
Gatifloxacin is an antibiotic whose use as an oral and injectable drug has been recently banned in India. This is due to its risk for severe hyperglycemia or high blood sugar levels in the elderly.
Tegaserod
Tegaserod is a drug that is used to treat patients with irritable bowel syndrome with predominantly constipation. It was withdrawn from the market since patients taking this drug showed increased incidence of heart attack and stroke.
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