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FDA raises concerns of consumer injury from new sleep aid

Medicines are meant to cure and provide better health, but when lab tests and trials fail to foresee dangerous side effects, they can cause injuries or even death. For example, although many sleeping drugs are effective, new drugs are sometimes found to cause unintended and unsafe physical and psychological effects. Here in Billings, Montana, products liability may result from prescription drugs that are found to be dangerous or defective products.

One such drug, Merck's suvorexant sleep aid, has recently received a lot of scrutiny from the Food and Drug administration. The FDA just released data that the drug can cause daytime drowsiness and suicidal thoughts when taken in higher doses. The medication works by temporarily blocking the brain messengers, called orexins, which keep a person awake. According to the report by the FDA, study subjects who received higher doses of the pill (in milligrams) were about eight times more likely to have daytime sleepiness. This side effect, according to the review, may result in sleep-related accidents.

In addition to daytime sleepiness, the experimental drug was associated with increased risks of suicidal thinking. In a span of 12 months, among patients taking the drug, eight cases of suicidal thinking and behavior were reported. The patients given placebos reported no such side effects.

The FDA states in its review that, if Merck can lessen the milligram dosage of the sleeping pill, there is a possibility that it can be safely marketed. However, since current recommendations are higher and tend to increase over time until a patient is cured from insomnia, the agency will consult with a panel of experts. If the FDA requires another study for the low dosage of the drug, it may take Merck 18 months to re-submit the drug for approval.

What the FDA is doing right now can save many lives. Although the product is still in testing and no product recall is necessary, stringent medication trials and reviews are needed because life is irreplaceable and company profit cannot come before consumer safety. If a medical product causes harm, a lawsuit may be filed to seek compensation.

Source: CBS News, "FDA raises concerns about experimental sleep aid suvorexant," May 20, 2013

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