Pills and the FDA

For an overweight or obese person to qualify for drug therapy, he or she must meet certain criteria. These are  

The patient must have a BMI greater than 27 kg/m2 and risk factors for  

The patient must have a waist circumference greater than 35 inches (89 cm) for women or 40 inches (102 cm) for men, and the risk factors stated above. 

It is important to realize that people who qualify for drug therapy do so based on health considerations and risk factors, not simply because they want to improve their appearance. Drug therapy is not undertaken for cosmetic reasons and should never be regarded as a shortcut or springboard to weight loss. Healthy diet and exercise are the keys to weight loss. 

The FDA s approval process for new prescription drugs is extensive. It can take over ten years for a drug to reach the market. Before receiving FDA approval, a new drug must be studied extensively. The process begins with the discovery or development of a new substance that can be used for medicinal purposes. The potential drug is first studied in a laboratory, then in animals. It is then studied in healthy adults to see what 

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Phenylropanolamine was initially believed to have a very low risk of side effects, and the FDA allowed it to be available over the counter, without a prescription. After some time, phenylpropanolamine became the active ingredient in many nonprescription diet pills, such as Acutrim , Dexatrim , and Protrim. Early studies demonstrated that the drug s main side effect was an increase in energy that sometimes led to insomnia or agitation. 

Although the feed additive uses of antibiotics have been emphasized, it should be noted that the uses as injectables for therapy, mammary infusions for mastitis, boluses, pills, capsules, medicated blocks, and drinking water formulations include a wider variety of antibiotics than are added to feeds. Many of these are currently used at the discretion of the meat producer or dairyman, others must be used under the direction of a veterinarian. For example, chloramphenicol is an antibiotic which the veterinarian has access to, but which the FDA has indicated should not be used in livestock destined for human consumption, primarily because of the... 

The Supreme Court rules in Upjohn v. Finch that the FDA properly removed Panalba and other similar antibiotic drugs from the market because of a lack of scientific evidence of their effectiveness and that past use by doctors and patients does not demonstrate the drugs work as purported. The FDA requires a PPI for birth control pills, first approved for public use in 1960. 

Recently developed drugs, known as ampakines, have been clinically shown to enhance learning and memory skills. These "smart pills" are being developed as a possible treatment for narcolepsy, attention deficit disorder, and Alzheimer s disease. Once approved by the FDA, physicians can prescribe them for off-label uses, such as jet lag or age-related forgetfulness.These agents act primarily within the central nervous system (brain and spinal cord), and they do not cause the jitteriness commonly associated with caffeine or amphetamines. 

Thalidomide, a sleeping pill, is discovered to be the cause of widespread and similar birth defects in babies born in England and western Europe. The FDA bans the drug in the United States. 

The diet pills developed to replace amphetamines became known as anorectics or appetite suppressants and are central nervous system stimulants. The FDA approved phentermine in 1959, fenfluramine in 1973, and dexfenfluramine in 1996. 

Comfrey (Symphytum officionale). Ointments made from comfrey are used topically for wound and bone healing. Comfrey tea and pills have been prescribed by herbalists to treat gastrointestinal ulcers and diarrhea. However, the FDA advised dietary supplement manufacturers to take comfrey off the market in 2001 because of the gathering evidence that comfrey taken internally causes severe liver toxicity. The FDA also noted the lack of evidence for comfrey s effectiveness. Comfrey should not be used by pregnant women or breastfeeding mothers. 

MPH is most often taken in pill form. It is available in prescribed quantities of 5-, 10-, and 20-mg tablets. A sustained or delayed release 20-mg tablet is also available. In 2001, the FDA approved Concerta, a longer acting MPH tablet that is taken once a day. Besides its long lasting action, Concerta has another benefit Abusers sometimes grind MPH tablets into a powder and snort it up their noses, but Concerta is formulated so that it cannot be ground into a powder. According to the DEA, methylphenidate abusers also dissolve the immediate-release MPH tablets in water and then inject the mixture. 

In 1996 the FDA approved the antidepressant bupro-prion (Zyban) for the treatment of nicotine dependence. This sustained-release pill blocks nicotine s pleasurable effects and helps to maintain abstinence whether the user has depression or not. The length of suggested use is for seven to 12 weeks, including one to two weeks before quitting tobacco. Buproprion doubles the quit rate and has been demonstrated to be safe when used jointly with NRT. 

What if you could put the benefits of tough exercise in a pill and sell it Supplement companies claim to have done just this. Pharmacies, health food stores, and the Internet are flooded with countless products claiming to help the body get rid of fat. So, do they work As with all supplements, that s an ongoing matter of debate. Fat burners and metabolism boosters are labeled "dietary supplements," since the FDA has yet to approve a medicine for this purpose. 

The FDA approves Alii, an OTC version of orlistat. It is the first-ever approved OTC weight loss drug of its kind, and the only approved OTC diet pill. 

The government is currently in the process of attempting to regulate ephedrine use in pep pills and supplements. The proposal is the FDA s first regulatory major initiative under the 1994 Act. According to the FDA, more than 800 adverse reactions, including seizures, strokes, and heart attacks, have been linked to ephedrine capsules, tablets, and teas since 1994. The FDA puts the ephedrine-related death toll at 18 since then. 

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