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The Central Drugs Standard Control Organisation (CDSCO) has named 24 drugs that have adverse reactions and that doctors must therefore prescribe with caution. The adverse drug reactions have been noted by doctors working in both the government and private sector and they have reported it to the Drug Control Authority. According to sources in the drug control department, “It is very important to have specific drug safety signals so that healthcare professionals are aware of the consequences of the drugs.”

These 24 drugs have been reviewed by the Signal Review Panel of the Pharmacovigilance Cell of India, which asked the CDSCO to take appropriate regulatory action against the drugs. Reaction to a drug like carbamazepine can cause Stevens-Johnson Syndrome where both layers of the skin are burnt. The patient has to be treated like a burns patient. Most patients do not survive because of the high rate of infection.

CDSCO has recommended HLA B 1502 as a screening test to be done before giving this drug. Sai Kumar, national president of the Doctor of Pharmacy Association, says, “The government has now made this test mandatory. Doctors have to carry out this test before administering the drug. Earlier, if the effects were seen after the drug was given the patient was put on burns treatment. But now they must first test and if it is found that the patient will have adverse reaction then this drug is not to be used. Alternative drugs can be used for treating this neurological condition.”

Ranitidine is found to cause cardiac arrest, anti-rabies vaccine can lead to acute skin infections, and itraconazole and phenytoin are also found to cause severe rashes in the body. The Drug Controller General of India has directed drug companies to include this information in the literature and on labels to avoid any problems.
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