Adverse Drug Reactions & the Safety of Pharmaceutical Drugs

With the recent warning issued by the Food & Drug Administration (FDA) about Simvastatin and the harmful effects it can have on muscles and kidneys, some are wondering why the drug did not come with more warnings sooner.

Simvastatin, marketed under drug name Zocor, was first approved in 1991 for the treatment of high cholesterol. The drug works to block the body's creation of cholesterol via the liver. Until 2010, the FDA had not issued any safety warnings about the drug. But after a study followed patients over a seven year span, the results prompted the FDA to warn consumers taking the drug about its potential side effects.

Public Citizen, a patient advocacy group, argues the FDA should have taken the 80 milligram (mg) dose of Simvastatin off the market completely. In fact, Public Citizen has added Simvastatin to its "Do Not Use" list of medications.

In 2008, statins like Simvastatin raked in $14.5 billion in sales in the United States. And researchers estimate that as many as 1.2 million people could be taking the dangerous 80mg dose of the drug right now.

Some argue that researchers have protected pharmaceutical companies by downplaying the dangers that drugs actually pose. Most people don't know that the average drug has 70 potential reactions. The most commonly prescribed drugs average 100 side effects each, but some have as many as 525 side effects. Couple this with the fact that the average American between the ages of 19 and 64 takes more than 11 prescription drugs, and you could have a recipe for disaster.

Between the number of drugs Americans take and the possible reactions each of those drugs can have, about 700,000 people visit the emergency room each year because of adverse drug reactions. According to the World Health Organization (WHO), an adverse drug reaction is an unintended reaction to prescribed drugs that occurs at doses which are normally used for treatment. Even drugs that are properly prescribed and properly administered can be potentially fatal. In fact, about 106,000 deaths per year are caused by adverse drug reactions.

The WHO reports that these adverse drug reactions are among the leading causes of death in many countries. But the good news is that deaths due to this are preventable. Harm from an adverse drug reaction can be minimized when medicines are properly studied to make sure they are of good quality, are safe, effective, and used by the right patient at the right time and in the right dosage.

For now, the FDA is sending the message that there are safer, more effective statins on the market than Simvastatin. All drugs come with some risk, and unfortunately, a side effect of statins is muscle damage. But where inadequate warnings have been given about a drug's potential risk, consumers need to be made aware and be informed.

The takeaway from this is that no drug is safe, and you should talk with your doctor about any side effects or potential side effects of the drugs he prescribes you.

For up-to-date information on Zocor and other dangerous drugs, visit www.pillmillmonitor.com.