Over-the-Counter Drugs - Laxatives
When people's bowels do not move as often as usual and the waste becomes hard and difficult to pass, they have constipation. Other symptoms may include lower back pain, a distended stomach, or a headache. Constipation is usually the result of limited water intake or a diet that is lacking in fiber. Fiber naturally provides bulk, which makes the waste soft and easy to pass. A diet that includes more fruits, vegetables and whole grain breads will provide more fiber. Also, certain diseases and drugs such as narcotic analgesics, antidepressants and antacids that contain aluminum may cause constipation. Lack of exercise may be a contributing factor as well.
Constipation is commonly treated with OTC drugs called laxatives, which stimulate bowel muscles or affect waste consistency. Laxatives are also used to prevent pain for people suffering with hemorrhoids or after childbirth or abdominal surgery. Laxatives should only be used for short-term therapy (no longer than a week) and should not be used to achieve weight loss. Overuse of laxatives is dangerous and can lead to severe deficiencies in vitamins and minerals. People can also develop a dependency on laxatives if they are used for too long; this can lead to chronic constipation.
There are two main types of OTC laxatives, and both affect the large intestine. Bulk-forming laxatives, such as Metamucil, absorb water, increasing the volume of waste in the bowel and making it softer and easier to pass. These laxatives produce results within twelve to seventy-two hours. Stimulant laxatives, such as Ex-Lax and Senokot, use senna to make the bowel muscle contract, which speeds the passage of waste through the intestine. Overuse of stimulant laxatives can cause dehydration, severe cramping, and loss of protein and potassium. Products such as Doxidan contain both a stimulant laxative and stool softener.
FDA APPROVAL
By law, all new drugs have to be proven effective and safe before the Food and Drug Administration (FDA) will approve them. Even with FDA approval, however, no drug is completely safe; there is always a risk of a bad reaction. The FDA must weigh the risks against the benefits when deciding to approve a new drug.
The process begins with the drug's sponsor, which is usually the manufacturer. The sponsor submits studies called new drug applications (NDAs) that show the effectiveness and safety of a drug. The NDA is supposed to tell the whole story about the drug, including what happened in the clinical trials; what components make up the drug; the results of studies on animals; how the drug behaves in the body; and how it is manufactured, processed and packaged. The clinical trials are especially important because they demonstrate how effective the drug is. (A clinical trial allows researchers to fully understand a drug—how it works, positive effects, negative side-effects, and how it is best used. People allowed to participate in drug trials usually share certain characteristics that make them appropriate for that specific trial. Furthermore, the trials usually take place under the supervision of a physician at a hospital, treatment center, or a university.) The human studies provide information that will be used for the drug's professional labeling, which is the guidance that the FDA approves for using the drug.
NDAs for drugs with the greatest potential benefit have priority over other NDAs. For example, all AIDS (acquired immunodeficiency syndrome) drugs have the highest priority, as well as drugs that offer significant advances over current therapies for any disease.
When the FDA analyzes a drug, the decision to approve it is based on two questions:
- Do the studies provide enough evidence of effectiveness?
- Do the results show that the product is safe (that the benefits outweigh the risks) when used according to the proposed labeling?
The FDA's review will have one of three outcomes. The FDA may tell the sponsor that the drug is approved. The drug is then placed on the market as soon as the manufacturer has production and distribution systems in place. The FDA may also tell the sponsor that the drug will be approved if minor changes are made, or that the drug cannot be approved because of major problems. At that point, the sponsor can either amend (change) or withdraw the NDA or ask for a hearing.
The approval process can be sped up for some promising experimental drugs. These drugs can be used in unrestricted studies that not only tell researchers more about the drug but that also make treatment available to people who have exhausted all available forms of treatment. These studies are used for drugs that treat serious or life-threatening diseases for which there is currently no viable treatment.
OTC drugs used to be approved using the same standards as prescription drugs. The FDA now classifies an OTC drug by treatment category (laxative, analgesic, etc.) and evaluates the ingredients. An OTC drug does not require specific approval as long as it meets the standards that the FDA has determined for the drug's category.
Laxative users should visit their doctors if they experience nausea, vomiting, bleeding, dizziness, or weakness while using OTC laxatives. Children under six should not use laxatives unless they have been so advised by their doctor.
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