The path to FDA approval is not always smooth and may take years. All pharmaceuticals in the United States must go through an approval process by the FDA through its Center for Biologics Evaluation and Research (CBER). Drugs for ADHD and related comorbid conditions are no exceptions. To have a drug approved, it must go through a long, rigorous period of development, testing, and then close scrutiny once it gets on the market. It may take 10 to 15 years for a new formulation to come to the market.

Even after years of scrutiny and tests, problems may arise after approval. For example, the FDA has issued a public health advisory regrinding the development of suicidal tendencies in patients treated with atomoxetine, and a ''black box'' warning was added to the labeling of that drug. The FDA has further mandated that all drugs approved for the treatment of ADHD carry guides to inform patients about the potential for cardiovascular risks and adverse psychiatric symptoms. Some adverse events such as sudden death in patients with underlying serious heart problems and a slight increased risk for drug-related psychiatric adverse events, such as hearing voices, was also found. Guides for patients, families, and caregivers will now be included in the package inserts with all ADHD prescriptions. With the significant abuse of some medications, regulatory actions from the FDA and Drug Enforcement Agency will be coming. Expect in the future ways to prevent potential problems as an added assurance for safety for patients, caregivers, and prescribers.

Some new formulations of drugs in novel classes are being studied. ABT-089 is a partial nicotinic receptor agonist for possible treatment for ADHD in adults. Also, the extended-release alpha-2-adrenoreceptor agonist guanfacine has passed the Phase I safety trials for treatment in adults.

Despite some advantages of drug therapy, not all people are comfortable with the use of long-term medications for children with ADHD. When first confronted with the prospective use, some parents may be hesitant. However, ADHD is a quite serious and disabling disorder, and if medications can help, parents should consider all options when making a decision. The important item for parents is to be patient and seek out a correct diagnosis.

A 2007 study has shown global use of ADHD medications has risen dramatically from 1993 to 2003. Published in the National Institute of Mental Health publication Health Affairs, researchers examined data from 70 countries in North America, Europe, and Northeast Asia and found among 5 to 19 year olds, use of medications to treat ADHD has increased by 274 percent. The United States prescribes the most ADHD medications, but its share of the worldwide market declined from 87 percent in 1993 to 83 percent in 2003. According to lead author of the study, Dr. R. M. Scheffler, ADHD is poised to become the world's leading disorder treated with medication; however, he emphasized the importance of clearly identifying the benefits and risks of these treatments and promoting careful prescribing and monitoring practices.

Bibliography:

Scheffler, R. M. et al. 2007. The global market for ADHD medication. Health Affairs 26 (2, March/April):450-57.

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