Drug Side Effects Explained
From the homely aspirin to the most sophisticated prescription drug on the market, all drugs come with side effects. Many are minor, some are just an inconvenience, a few are serious, and some are just plain strange.
Perhaps the most common set of side effects for drugs taken internally involves the gastrointestinal system. Nearly any drug can cause nausea or an upset stomach, though it may only happen to a handful of users. For drugs used externally, skin irritation is a common complaint.
Drug Side Effects: Types
Side effects fall into several categories:
Allergic reactions can happen with any drug and can range from itching and rash all the way up to a life-threatening anaphylactic reaction.
Some drugs can’t help but trigger side effects because of their chemical structure. One example is the common allergy drug diphenhydramine (also known by the brand name Benadryl). Though it eases allergy symptoms, it also suppresses the activity of the body chemical acetylcholine, and that leads to drowsiness and a host of other side effects, including dry mouth.
Some drugs have barely noticeable side effects when dosed properly. For example, Warfarin (Coumadin, Jantoven), used to prevent blood clots, is usually well tolerated, but serious internal bleeding can occur.
Side effects may only pop up when certain drugs are mixed with certain other things. These might also be considered drug interactions. Drinking alcohol with narcotic painkillers has caused an alarming increase in accidental overdose deaths. Drinking grapefruit juice can affect the blood levels of several drugs, including the heart drug Digoxin.
To find more about a drug's side effects, information about them is available on the label of over-the-counter drug products and on package inserts or printed materials dispensed with prescription drugs. Because the inserts include such a long list of possible bad effects, it is very helpful to also talk to your pharmacist or doctor if you have any questions regarding a drug's side effects.
Drug Side Effects: The FDA's Role
Before a drug can come on the market it must be approved by the FDA. The New Drug Applications (NDAs) submitted by pharmaceutical companies contain, first and foremost, clinical evidence that the drug has the therapeutic effect it’s supposed to have and is safe. This proof comes from testing of the drug, first in animals and then in humans. Once the basic questions of safety and efficacy are settled, the FDA will approve the drug if it deems that its benefits outweigh its risks.
Still, sometimes not everything is known about a drug’s side effects until after it enters the marketplace and more people start using it. That’s where MedWatch comes in. The FDA’s post-marketing surveillance program seeks voluntary input, mainly from health care professionals, on adverse effects they may be seeing in ''the real world.'' Sometimes these reports are numerous and/or serious enough for the FDA to take regulatory action, such as adding warnings to a drug’s label. One example of that involves the psoriasis drug Raptiva. The FDA required that the drug carry the agency's strongest warning, known as a black box warning, after it received reports of brain infections and meningitis in patients taking the drug.