So it came as no surprise when Glaxo Smith Kline (GSK) was recently fined three billion dollars for promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA). Treating an illness with a medication that has not been approved specifically for that condition is called “off label use”. Although it is not illegal, it is considered by many physicians to be an irresponsible practice. Failure to report adverse side effects, or to misrepresent the frequency of side effects, is also a common and inexcusable practice by drug manufacturers. Nonetheless, pharmaceutical companies will sometimes weigh the fines and bad publicity against the financial advantage of selling a drug until it is pulled off the market by regulatory agencies.
These scenarios are potentially more dangerous for travelers and expats in countries where regulations are lax and new medications are sometimes prescribed before being fully scrutinized by the U.S. Food and Drug administration. That’s HTH Worldwide strongly encourages patients receiving unfamiliar medications outside the United States to check with our global health team to make sure that an FDA approved equivalent is available stateside, and is being appropriately prescribed. As the GSK behavior reveals, FDA approval does not mean that the medication is being recommended according to guidelines, or that adverse side effects have been fully disclosed. HTH Worldwide makes every effort to encourage the use of well known, time tested medications by everyone, particularly those abroad.
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