Drug Side Effects

It doesn't matter whether we're talking about aspirin or the most sophisticated pharmaceutical 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 thegastrointestinalsystem. 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.

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.

• Other side effects simply come with the territory. Some drugs can't help buttriggerside effects because of their chemical structure. One example is the common allergy drugdiphenhydramine(also known by the brand nameBenadryl). Though it eases allergy symptoms, it also suppresses the activity of the body's chemicalacetylcholine, 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 (Jantoven,Coumadin) 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 withnarcoticpainkillers can lead to trouble breathing. Drinkinggrapefruitjuice can affect the blood levels of several drugs, including the heart drugdigoxin.

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. You can also talk to your pharmacist or doctor if you have any questions regarding a drug's side effects.

药物之前来吧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 seeksvoluntaryinput, 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 drugRaptiva. 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 andmeningitisin patients taking the drug.

The FDA also wants input from consumers when it comes to side effects. Beginning in July 2009, all dispensed prescriptions, and manyOTCproducts, must be labeled with a toll-free number maintained by the agency for the purpose of reporting side effects of drugs, called "adverse events."

Sometimes, the postmarketing information coming into the FDA is so disturbing that it results in a drug coming off the market.Baycol, which lowerscholesterol, was strongly linked to a potentially fatal breakdown of muscle tissue. Approved in 1997, it was voluntarily withdrawn four years later. The anti-inflammatory drug Durant spent just one year on the market. Approved as a strictly short-term use product, the FDA found serious liver problems with people taking the drug for longer than what was recommended.

The FDA gathers adverse event information from drug companies, as well. Drug companies are required to report adverse events to the FDA, and failure to do so can lead to prosecution. In 1985, employees of two drug companies were fined and/or sentenced to community service for not reporting adverse events involving the blood pressure drug Selacryn and arthritis drug Oraflex. Both products were pulled from the market.

但并不是每一个副作用是坏的。有些是维ownright welcome. Takefinasteride. Introduced in 1992 to treat noncancerous enlargement of the前列腺, it was found to regrow hair. Today, millions of men use a low dose of finasteride to treat male patternbaldness. A similar thing happened withminoxidil. Originally marketed as an oral tablet forhigh blood pressurein the 1970s, it was found to grow hair in those using it. Today, as a topical lotion or foam, it is a popular over-the-counterremedyfor baldness.

SOURCES:
FDA.National Library of Medicine.
www.nader.org.
MedicineNet.