Report Strange Side Effects or Malfunctioning Medical Devices
Recently we learned about the third recall of Tylenol products in the past eight months. Children’s pain and allergy products have been recalled twice. The third was a result of a hijacked ship-load of Tylenol, stolen as it was brought into the United States.
Tylenol’s manufacturer, Johnson & Johnson, is considered to be a good corporate citizen. When problems crop up, they let us know and act responsibly. Think back to the early 1980s when tainted Tylenol resulted in several deaths. Even though the Tylenol had been tampered with, they stepped up to make it as right as they could for consumers.
But these recent recalls prove that even good corporate citizens can create safety problems for patients. In fact, since January, more than a dozen pharmaceutical, dietary supplement and medical device companies have issued recalls – some voluntary and some required by the FDA. From diabetes supplies to dietary supplements to catheters used on hospital patients, dozens of products have been recalled or withdrawn from the market completely.
What makes these products dangerous? Sometimes substandard manufacturing is the culprit. Questionable ingredients get mixed into a drug or damage occurs during the manufacturing process. Some are manufactured overseas where standards do not meet the FDA’s guidelines. Bits of a machine get mixed in, or the components used are inferior. Other products are counterfeit and have made their way into our American drug or device supply.
While there is very little we patients can do to protect ourselves from being supplied with problem products, there is something we can do to assist the process of identifying them. The sooner problem drugs and devices are identified, the quicker they are pulled from the market. Then fewer people suffer from strange side effects or even real harm.
If you believe something is not right about a drug or medical device, and your doctor didn’t mention that problem to you as a potential side effect, or you don’t see it listed on the label or packaging, you are asked to report it to the FDA. The FDA’s MedWatch program gathers evidence of dangerous and hazardous medical products. When enough reports are made, a recall will be initiated.
It's easy to report problem drugs and medical devices to MedWatch. Link here for step by step instructions.
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Trisha Torrey
is the author of
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