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OTC drugs: Medicine’s dark side

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There are more than 100,000 different OTC remedies available for us to self-medicate a range of common ailments-including migraine head-aches, insomnia, stomach pain and indigestion problems, arthritis, general aches and pains, and coughs and colds-as well as products to help us lose weight and stop smoking.

Because we can walk into any high-street pharmacy or chemist and buy them with a minimum of fuss and questions asked, we believe they are safe for us to take. And because we think they are safe, we are much more likely to take several OTC drugs in combination, even though they may well share some of the same active agents, thereby increasing the amount of each agent we are taking every time. Indeed, the US Centers for Disease Control and Prevention (CDC) has also reckoned that around half of all child-ren under the age of three years are regularly given an OTC preparation, such as Tylenol or Calpol.
Their potential dangers appear to become the subject of public concern only when they affect a celebrity, such as Hollywood film actor Heath Ledger, who died in 2008 after overdosing on OTC sleeping pills, to which he had become addicted.

Tragically, many hundreds of thousands of people suffer the same fate as Heath Ledger every year as a direct result of an OTC drug-but their deaths are never recorded as such because there is no monitoring system in place.

Researchers at the Eastern Virginia Medical School reckon that OTC pain-killers that contain aspirin are, on their own, responsible for 20,000 deaths and 100,000 hospitalizations every year in the US. Yet, not only are these drugs never suspected of being the cause, but most patients who need hospital care don’t even bother to mention that they were taking such drugs as aspirin-so harmless are OTC drugs thought to be.

As the lead researcher and gastro-enterologist of the above report, Dr David Johnson, has said: “This reflects a common misperception that these medications are insignificant or benign when actually their chronic use, particularly among the elderly and in those with conditions such as arthritis, is linked to serious and potentially fatal GI [gastrointestinal] injury and bleeding” (Proceedings of the Annual Scien-tific Meeting of the American College of Gastro-enterology, October 15, 2007, Philadelphia, PA).

In fact, millions of people may well be addicted to OTC drugs, especially those that contain codeine, which is a controlled substance derived from opium. However, it’s a major social problem that remains invisible, as the UK government’s All-Party Parliamen-tary Group on Drug Misuse is discovering. Dr Brian Iddon, the cross-party group chairman, said: “Our inquiry has only scratched the surface of this problem.” Yet, it isn’t clear how his enquiry can ever go deeper, as there are no records of who is buying these drugs and how often, although one place that the enquiry could start is with a self-help group of 4000 people registered on a website because of their addiction to Solpadeine, an OTC concoction of codeine and parace-tamol (BMJ, 2007; 334: 917-8).
Very few people who are regularly self-medicating realize that the drugs they are taking invariably contain active ingredients, such as codeine, that have never been subjected to any rigorous safety tests. In the UK, a regulatory framework for OTC drugs came into existence only in 1971-and, in the US, in 1962-so any active compound that was introduced before those dates has never been tested. This means that agents such as aspirin, codeine, dextromethorphan (DXM), paracetamol (acetaminophen in the US) and diphenhydramine have never passed any proper safety trials, and yet they are found in many popular household OTC brands such as Alka-Seltzer, Calpol, Tylenol and Vicks.

Double trouble

The OTC market has been earmarked as the next major happy-hunting ground of pharmaceutical companies. Over the next few years, we are likely
to see many more powerful drugs-that up to now, have only been available from the doctor and only with a prescription-put on the shelves for everyone to buy.

Thousands of prescription-only drugs have already made the transition to OTC-a process known as ‘Rx to OTC’ in the US and as ‘OTC switching’ in the UK-and many more are expected to follow suit as patents expire on a host of blockbuster prescription drugs. One example from last year was the switching of Novartis’ Prevacid 24HR, a heartburn remedy and the first proton-pump inhibitor to obtain OTC approval in America since 2003. As a prescription drug, it was among the top five best-sellers in the US, with annual sales of $3.37bn in 2008-and yet, it has now become an OTC remedy that is being marketed directly to the approximately 50 million Americans who suffer from frequent heartburn ( article/idUSLE40551720090514).

As a result of this refocusing, the OTC market-already worth around $7.8bn in the US this year, and consis-tently growing by 8 per cent annually since the early 1990s-is set to double by 2023, according to the World OTC Pharmaceutical Market Analysis & Forecasts, 2008-2023 ( publications/otc/world_otc_pharmaceutical_ market_analysis_forecasts_20082023.html).

Although the prescription drugs market is far more lucrative, the pharmaceutical industry is being forced to change its strategy. The industry is reaching a significant watershed as scores of big-selling proprietary drugs are soon to lose their patents, which would allow a wash of cheaper ‘me-too’ generic drugs from competitors onto the market. To counter such an event, a drug company often adopts a double-pincer move by, on the one hand, ‘supercharging’ the prescription drug-such as by increasing its potency or making a minor change to the formulation-which would then allow it to extend
its protective patent while, on the other hand, making the original drug available in the OTC marketplace.

The types of drugs that are expected to make the switch include gastro-intestinal remedies, cholesterol-lowering agents, osteoporosis treat-ments and contraceptives. Also, the pharmaceutical industry is fiercely lobbying drugs regulators such as the US Food and Drug Administration (FDA) to extend the categories of agents that can be sold as OTC. It’s a battle they’re expecting to win, and new categories are “likely” to be included in the OTC arena, says industry analyst group Kalorama (

However, the battle is already all but over in the UK, which is known to operate one of the most liberal drug-licensing regimes in the world, where cholesterol-lowering statin drugs were allowed to be sold without a pres-cription as early as 2004.

The British drugs regulators were undeterred by the dubious safety record of statins, which lists heart failure, liver and kidney damage, and a potentially fatal muscle-wasting dis-order known as ‘rhabdomyolysis’ among their side-effects. In 2001, one statin, Baycol, was withdrawn from the market after 31 people died because of rhabdomyolysis in the US and after being linked to around 100 deaths worldwide ( 1481178.stm;

As a spokesman for the pharma-ceutical market research company Piribo states: “The worldwide OTC market will see a remarkable period of dynamic change. Ageing populations and rising incidence of lifestyle diseases, as well as the need to reduce healthcare costs, will open up new therapeutic areas for OTC switching.”

This explosion in OTC sales is also fuelled by consumer demand. More and more people are looking to self-medicate, which they consider to be inexpensive, convenient and safe, compared with a visit to the doctor, which might involve a more careful review of the problem. Consumer demand for the heartburn remedy Prilosec became so great in 2004 that pharmacies were out of stock for most of the year. Although manufacturer Proctor & Gamble increased its production, it wasn’t until 2005 that shelves were replen
ished (Berenson A. Where Has All the Prilosec Gone? The New York Times, March 3, 2005).
To make the switch from pres-cription to OTC, the drug manufac-turer will often reduce the dose level or change the formulation to produce a ‘weakened’ version for the mass market. Nevertheless, these smaller dosages can still be lethal, and is certainly addictive, as the few statistics that are available demonstrate.

Indeed, our drugs watchdogs are at pains to point out that there is no such thing as a safe drug, and they urge consumers to read the label before taking any medication. But as OTC regulations are far less rigorous than they are for prescription remedies, the demands and guidelines for the manufacturer regarding the inclusion of patients’ information are hardly onerous. For example, the safety sheet that comes with the prescription-only version of Motrin, a painkiller that contains ibuprofen, includes possible side-effects such as oedema, blurred vision, nausea, heartburn, diarrhoea, gastric ulcer with bleeding and/or perforation, dizziness, nervousness, rash and tinnitus. In contrast, the label on the OTC version of Motrin merely mentions that “ibuprofen may cause stomach bleeding”, and the list of side-effects has been omitted.

Hidden interactions

The OTC drug manufacturer also doesn’t have to make any mention of the fact that the remedy can interact with other drugs or remedies, including vitamins. Paracetamol (acetaminophen) is a common pain-killing agent found in hundreds of OTC remedies and, yet, none of them mentions that it can increase bleeding, possibly to a dangerous level, if taken in conjunction with the blood-thinning drug Coumadin (warfarin).

The FDA is also becoming increas-ingly concerned about prescription drugs that contain acetaminophen, and one of their advisory committees last year went so far as to recommend that all drugs that combined this agent with narcotics should be immediately removed from the market.
The committee argued that the chances of overdose and severe liver injury were high, and that the risks far outweighed any benefits that such drugs-which include Vicodin and Percocet-offered.

Also, the report stated that aceta-minophen, which is commonly used to reduce fever, had been linked to 56,000 emergency room visits, 26,000 hos-pitalizations and 458 deaths during the 1990s in the US. Yet, no one recommended that any OTC drug containing acetaminophen be taken off the market (http:// 2009/06/30/fda-panel-urges-ban-vicodin-percocet/).

Acetaminophen is even suspected of being a cause of autism. It’s found in the children’s OTC remedy Calpol, which is regularly used by parents to reduce fever, which also commonly occurs after receiving the MMR (measles-mumps-rubella) vac-cine. In one study of 83 children with autism who were compared with 80 healthy, non-autistic controls, the children who were given an aceta-minophen-containing remedy were six times more likely to develop autism after the vaccine, and nearly four times more likely to suffer regression in their development, compared with the controls. The children who had been given ibuprofen to treat fever after the MMR vaccine had no autism (Autism, 2009; 13: 123-4).

Most cough medicines include dextromethorphan (DXM) and, yet, the warning-if there is one at all-is woefully inadequate. Although one OTC preparation, Robitussin, men-tions that it shouldn’t be taken with any prescription antidepressant known as an MAOI (monoamine-oxidase inhibitor), it doesn’t state that the interaction is, in fact, life-threatening. DXM also interacts with other anti-depressants such as Prozac, Paxil and Zoloft (all of which are SSRIs, or selective serotonin-reuptake inhibi-tors), to produce a serious condition known as ‘serotonin syndrome’, which can trigger symptoms such as muscle twitches, fever, nausea, dizziness, confusion, shock and coma. DXM side-effects, even when not mixed with another drug, include impaired judgement, loss of coordination, dizziness, nausea, hot flashes, hallucin-ations, brain damage, seizure and death. Again, virtually no OTC drug that contains DXM mentions these possible adverse effects.

Drug manufacturer Merck, which also publishes The Merck Manual of Medical Information, says: “Often, the labels of OTC drugs do not list the full range of possible side effects. As a result, many people assume that these drugs have few, if any, side effects. For example, the package insert for one analgesic (not named) cautions people not to take the drug for more than 10 days for pain. However, the possible serious side effects that can occur with long-term use (such as life-threatening bleeding from the digestive tract) are not mentioned-not on the box, bottle, or package insert” (www.merck. com/mmhe/print/sec02/ch018/ch018a.html).

America’s Generic Pharmaceutical Association (GPhA) recognizes the double standards that now apply to prescription and OTC drugs, and is calling for the same approval process for all drugs, irrespective of the way in which they reach the marketplace and consumers. “While FDA-approved prescrip-tion drugs are subjected to a rigid application-based approval process. . . other products are marketed either under a minimally regulated system or no regulatory system at all. Specifically, numerous OTC drugs have been on the market for years and some predate the laws that require proof of safety and effectiveness before marketing . . . [so] the unregulated OTC drug market continues to fall between the cracks,” an association spokesman says ( media/press-releases/2009/02/12/fda-standards-and-foreign-inspections).

Double blind

With the OTC market becoming the new focus of Big Pharma, it is imperative that it is protected by the same regulatory framework that controls prescription drugs. While it is forgivable that the consumer might believe OTC drugs are safer, it’s not acceptable that our drugs regulators should also share the same view.

In fact, the regulators know that OTC drugs are every bit as dangerous as their prescription counterparts, even though they may be acting otherwise. Why else do OTC drugs not have to list all of their possible adverse effects, or any of their possible interactions with other drugs and medications.
But worse than that is the fact that the OTC market is completely invisible. Nobody knows who is buying these drugs or what happens to them afterwards. This is because there’s little incentive-and almost no funding-to investigate the dangers of OTC drugs. However, the little that has been done uncovers a worrying picture, with aspirin alone causing around 100,000 deaths worldwide every year.

The OTC market is truly medicine’s dark side, but it’s time that light be shed upon it.

Bryan Hubbard


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