Cough, Cold, Weight Loss Drug Dangerous
Even common products that are available without a prescription (over-the-counter) can be dangerous if used improperly.
With all the choices of over-the-counter products available in the marketplace, it is increasingly difficult to select the proper product(s) for you and your family. To help you in your decision-making process, the MedicineNet.com Doctors and Pharmacists have provided an easy-to-follow format to help you understand which products may work better for specific conditions and how to choose the products that are most appropriate for your needs. We recommend our references in Making Sense of Over-The-Counter Products as an excellent resource when you are uncertain of how the ingredients in common over-the-counter remedies may affect the symptoms you want to treat.
Because of the urgency broadcast by the U.S. Food & Drug Administration (FDA) and the widespread use of the product phenylpropanolamine, we are republishing below the actual FDA Health Warning for MedicineNet.com viewers.
--Medical Editor, MedicineNet.com
FDA ISSUES PUBLIC HEALTH WARNING ON PHENYLPROPANOLAMINE
November 6, 2000--FDA, today, is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.
FDA today issued a public health advisory concerning the risk of hemorrhagic stroke, or bleeding into the brain, associated with phenylpropanolamine hydrochloride.
Phenylpropanolamine is an ingredient used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.
Adverse events reported with these products led to concerns that this ingredient might increase the risk of hemorrhagic strokes. Manufacturers of products containing phenylpropanolamine worked with FDA to plan a research program to clarify whether any increase in risk exists.
Scientists at Yale University School of Medicine conducted the study in which the researchers found an association between phenylpropanolamine use and stroke in women. The increased risk of hemorrhagic stroke was detected among women using the drug for weight control, and for nasal decongestion, in the 3 days after starting use of the medication. Men may also be at risk.
The Nonprescription Drugs Advisory Committee met on October 19 to discuss safety issues related to phenylpropanolamine use. The committee reviewed Yale's Hemorrhagic Stroke Project results and concluded that phenylpropanolamine cannot be considered to be safe for continued use.
FDA believes that although the risk of hemorrhagic stroke is very low, even with phenylpropanolamine use, the conditions for which these products are used do not appear to warrant an increased risk of this serious event from using this drug. We advise consumers to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.
Below are some important Q&A's about this voluntary recall:
2. Are there any population groups at higher risk when using
products containing phenylpropanolamine?
3. If a patient brings me, a pharmacist, a prescription containing
phenylpropanolamine, should I fill it?
4. My family has been using products that contain phenylpropanolamine; is
there any danger?