Safety of over-the-counter drugs: Be careful with headache and cold medicines

2011
By Syed Akbar

First year BCom student P Pranita did not know that she was actually consuming a sort of poison when she took a tablet for severe headache. The 18-year-old girl was apparently influenced by a TV advertisement, pushing across an over-the-counter or OTC drug for headache and cold. The girl soon developed severe drug  complications and died a few hours later. Doctors suspect that the girl might have been suffering from some  underlying cardiac or liver problem and the chemical ingredients in the "headache tablet" had 
suddenly aggravated it.
Pranita's death has brought to the fore the debate on the safety of OTC drugs, some of  which contain active
ingredients banned in developed nations. The "headache-cum-cold" tablet the girl took is easily available even with a panwalla as it can be sold without prescription.
The medicine allegedly taken by Pranita contains 500 mg of paracetamol, 10 mg of  phenylephrine hydrochloride, and 32 mg of caffeine anhydrous, besides a harmful colouring agent. While caffeine anhydrous is  a natural pesticide in plants and a powerful psychoactive substance in human beings, paracetamol, which gives  relief from pain and fever, is derived from coal tar and is known for its adverse side effects.
Doctors believe that the combination of paracetamol, caffeine and phenylephrine  hydrochloride may have aggravated an underlying health problem in the girl. The reaction was quick as the girl was on empty  stomach.
Like many others, the girl did know that she was taking three medicines for one problem  (headache).
Phenylephrine hydrochloride is a powerful decongestant and opens up the nasal blockade in  case of cold. There have been debates in developed nations including the USA on the need to regulate it. There are also arguments that the drug does not serve its purpose, but only increases the blood pressure.
"Cold and cough prescriptions should be advised by the doctors keeping the age and  patient condition in mind," says senior physician Dr Aftab Ahmad. Discouraging use of OTC drugs, he says certain ingredients in these can have harmful effect on heart and can be fatal leading to death.
According to him, cold remedies can increase blood pressure and lead to fast and  irregular heart beat with serious consequences. In Pranita's case, headache could be because of cold and an underlying  cardiac problem could have got aggravated. "Since it is dangerous, it should not be sold as OTC drug," he points out.
The tablet must have triggered hypertension in the girl leading to headache and nausea  and as the girl was on empty stomach it caused severe weakness. "Phenylephrine hydrochloride is not advised for people  with a history of seizures (epilepsy) and those with high blood pressure. As many do not know the side-effects of 
certain drugs, it is always better to take medication under the supervision of a doctor or a qualified pharmacist," warns physician Dr M Ramachandra Murthy.
People should be extra cautious about certain "cold and cough" drugs as they may trigger  stroke or seizures and cause abdominal cramps, says pharmacist S Koteswara Rao. Some drugs like decongestants increase the heart beat, elevate blood pressure, and cause restlessness. The complications can be dangerous if  they are taken on empty stomach.
Any medicine taken on empty stomach mixes fast with the blood stream and if the drug is  known for its side-effects, the results can be quite dangerous, says Dr Aftab Ahmad. Doctors point out that the side-effects of cold and headache  medicines include dizziness, vomiting, irregular heart beat, stomach upset, and damage to liver.
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How to use OTC drugs
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1. Never get influenced by TV advertisements on pain and cough relievers. Certain seemingly harmless drugs can be fatal for some individuals. Do not take overdose of medicines i.e two or more same tablets at a time. It will increase the drug potency, which the body may not tolerate.
2. Always consult a doctor or a qualified pharmacist even if you want to use OTC drug.  Certain drugs react severely if a person is already on other medication. Drug-drug reaction is potentially dangerous.
3. Never exceed the dose prescribed. Simple drugs like paracetamol can stay within our  body for as long as five years. The drug traces build up in the body resulting in a synergetic effect, which can be quite harmful.
4. Check for the active ingredients in a medicine. Do not go by the brand name.
5. Always use single drug medicines if you are suffering from one problem. Multi-drug tablets will only harm the body and give unnecessary resistance to medicines. When required, these drugs will not work thanks to body resistance.

Be cautious about OTC drugs

By Syed Akbar
Hyderabad: Suffering from headache, loose motions or common cold? Just don't rush to a chemist for an over-the-counter (OTC) medicine. Chances are that you may develop nausea, severe allergic reactions, kidney failure or even cancer.
More often than not the blame does not lie with the chemist but with the type of drug he gives you. As many as a dozen generic or basic drugs, which have been banned world-wide, are freely available in twin cities. Strangely enough, these drugs enjoy the legal status as they are yet to be banned by the Indian government.
"For a drug to be banned the Central government needs concrete evidence supported by research studies on its bad side-effects. Unfortunately, in India we do not have post-drug follow-up records. Pharmaceutical companies take advantage of this", argues R Uday Bhaskar, secretary-general of All-India Drug Control Officers' Confederation.
He, however, wants these drugs to be banned as "what is bad for people in the USA and Europe is equally bad for Indians, whether we have post-drug follow-up studies or not".
The Central government has banned 76 categories of Fixed Dose Combination or individual drugs. Ironically, the government banned these drugs only after the manufacturers voluntarily withdrew them. Rofecoxid is one such drug. It was found to be dangerous to heart patients. However, many irrational combination drugs are still sold freely.
Some of the drugs banned in the USA, European Union, Australia and developed countries but still available in India are:
Analgin (pain-killer), Cisapride (acidity, constipation), Droperidol (anti-depressant), Furazolidone (anti-diarrhoea), Nimesulide (pain-killer, fever), Nitrofurazone (anti-bacterial cream), Phenolphthalein (laxative), Phenylpropanolamine (cold and cough), Oxyphenbutazone (non-steroidal anti-inflammatory), Piperazine (anti-worms) and Quiniodochlor (anti-diarrhoeal).
Nimelsulide, a non-steroidal anti-inflammatory drug, has been banned in many countries for its reported liver toxicity. The Central government approved Nimelsulide in 1994 for treatment of painful inflammatory musculo-skeletal disorders but many doctors prescribe it for ordinary pain and fever. Nimelsulide and Cyproflaxin (100 mg) have been banned for paediatric use but doctors continue to prescribe them for children.
Dr SV Chandrasekhar, consultant surgeon of Apollo Hospitals, says drugs like analgin should not be used for children while furazolidone is equally bad for adults and children. "Combination drugs are not advisable. When a patient suffers from one problem why should he or she be given a combination of drugs? Vitamins are always sold in combination. A person does not suffer from deficiency of several vitamins or minerals at a time. Overdose may cause severe problems", he points out.


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The side-effects:
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1. Analgin (it is used in dozens of drugs including Novalgin): Causes bone marrow depression, ulcers and reflex action.
2. Cisapride (available under brand names Ciza and Syspride): Causes irregular heartbeat and palpitation.
3. Droperidol (brand name Droperol): Affects the heart and blood circulation.
4. Furazolidone (Furaxone, Lomofen): Nausea, severe headache, cancer and damage to intestines.
5. Nimesulide (Nise, Nimulid): Causes liver failure.
6. Nitrofurazone (Furacin): Causes cancer.
7. Phenolphthalein (Agarol): Found to be carcinogenic.
8. Phenylpropanolamine (D'Cold, Vicks Action-500): May lead to stroke.
9. Oxyphenbutazone (Sioril): Bone marrow depression.
10. Piperazine (Piperazine): Causes damage to nerves.
11. Quiniodochlor (Enteroquinol): Damages eyesight.

Drugs under watch list

2006
By Syed Akbar
Hyderabad, Oct 16: The Central government has put 11 drugs under watch for their reported side-effects as part of its pharmacovigilance programme.
According to Rajesh Bhushan, director, Union Ministry of Health and Family Welfare, the government will take a decision on banning or otherwise of these drugs after gathering feedback from stake-holders. He said these drugs include pain-killers, cardio-muscular and anti-pyretic.
"We have already banned Rofecoxib and Valdecoxib after it was established that the are not good for the health of our people," he said.
Rajesh Bhushan told reporters at the National Institute of Nutrition here that the MHFW had sought the cooperation of healthcare professionals
in collecting data of adverse events related to drugs marketed in India. The submitted data will be collated and evaluated by the National Pharmacovigilance Centre operating at the department of pharmacology,
All-India Institute of Medical Sciences, New Delhi.
Referring to the drug sector scenario in the country, Rajesh Bhushan said laboratories required urgent upgradation for increasing capacity and competency. He regretted that all imported drug batches were not tested. A large number of vacancies in Central Drugs Standard Control Organisation and Central and State laboratories were coming in the way of effective implementation.
He agreed that there were constraints in existing testing capabilities and capacities especially for contaminants and microbiological parameters.