Are OTC pain medications safer than prescriptions?

Question

Are pain medications that I can buy Over the Counter (OTC) any safer than prescriptions I receive from a doctor to manage pain?

For example, I have migraines. There are several OTC medications advised for migraines:

• Acetaminophen/Paracetamol
• Aspirin
• Ibuprofen
• Naproxen

While my headache specialist has prescribed several other medications for my pain:

• Imitrex (and other triptans)
• Midrin
• Prochlorperazine
• Cambia
• Anaprox

Are the OTC pain medications safer? Why are some pain medications OTC and others only available by a prescription?

Answer 1

As a medical professional I find this very important question. No, OTC drugs are not any safer than drugs needing prescriptions. They are more dangerous.

The rationale for this statement is that always when patients are given a prescription, a detailed dosing guidelines are given to patient. Also physicians make sure that the prescripted drug is suitable to use with existing medication without any adverse interactions.

In contrary, people can buy OTC drug as much they can and use them how ever they feel it is possible. Of course, majority of patients ask or seek for guidance, but in population level there will always be the minotiry who use OTC drugs with high doses and experience adverse events.

They reason why paracetamol/ibuprofen/aspirin are OTC drugs is that these drugs have quite a few interactions with other drugs. Paracetamol is the safest minding the correct dosing. Daily dosage exceeding 4g are associated to liver damage. Ibuprofen and other NSAIDs cannot be used with warfarin, which is pretty much the only major interaction. Adverse effects include GE tract bleeding and kidney injury if daily dosage is high or there is pre-existing condition.

The rest of the drugs You mention are highly spesific drugs with complex mechanism of actions and they have many significant interactions and contra-indications. Proper assessment must done by a professinal and not by common people.

It varies from country to country and depends on local regulation which drugs are OTC. Usually the safest one are, like those you mention and for example antihistamins and some proton-pump inhibitioners. There must be an equilibrium which drugs are OTC and which are not. Certain drugs must be OTC so people can buy those freely and does not need to see a doctor every time they need paracetamol. That would pose a significant burden for health care system. Also, not all drugs should be OTC, most importantly those which have many major interactions and those which are suitable for abuse. Moreover, majority of drugs are used for treatment of chronic diseases so when people run out of prescription they must meet their doctor and thus the status of any illness can be assessed.

Answer 2

Generally, I'd say no, OTC medications are not safer than prescribed medications. However, I disagree with the opinion that they are more dangerous. Primarily I'd like to address a misconception people have about OTC medications (meds). (I will not discuss dietary supplements - also potentially very harmful - because the FDA does not regulate these.)

Many people think that OTC meds are safe because "the government wouldn't let a dangerous medication be sold over the counter, would they?" In the US, the "government" usually is a reference to the Food & Drug Administration. The answer is:

Yes, the FDA does allow dangerous medications be sold over the counter.

Just look at acetaminophen/paracetamol (ACAP). Before blister-packs were mandated for ACAP, it was the drug of choice for suicide in the UK.

While it is true that the FDA must approve both OTC and prescription drugs, they are assessed for safety, efficacy, possible drug interactions, and appropriate dosages. ACAP is OTC because used as directed, the benefits significantly outweigh the risks. This does not address OTC meds that were once FDA approved but have lost approval because of poor labeling practices¹

Are prescription medications safer because they are "prescribed"? Not really, because many patients (in many studies, up to 50-60%, which is believed to be an underestimate) don't take their medication as prescribed. This poses a significant burden to health care costs and utilization.

Clearly not all medications eventually become OTC - I don't expect to ever see chemotherapy drugs go OTC, for instance. But many do. This has something to do with patent expiration, being beneficial to patients who can't afford a physician for treatment of common illnesses, e.g. gastric reflux or (in days bygone) gastric ulcers. Allergy medications usually become OTC, antibiotics (in Mexico and other countries), etc.

Drugs are drugs, inherently dangerous when the risk outweighs the benefit or when used improperly. So is water. Too much or too little will kill you; it doesn't mean bottled water is safer than tap water in that instance.

_{1 Unapproved Prescription Cough, Cold, and Allergy Drug Products: Recent US Food and Drug Administration Regulatory Action on Unapproved Cough, Cold, and Allergy Medications
Patterns of use and public perception of over-the-counter pain relievers: focus on nonsteroidal antiinflammatory drugs
Long-term Persistence in Use of Statin Therapy in Elderly Patients
Medication adherence}