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Non-Prescription and Over-The-Counter Drugs

The Problem

The warnings on many previously-prescription drugs have been weakened. Over-the-counter (OTC) drugs can be sold directly to consumers, with fewer warnings than had previously been given to the doctors who used to prescribe these drugs. No longer is the consumer protected by the doctor who acted as a "learned intermediary".

The Duty

Normally, drug manufacturers have NO DUTY to warn consumers of their drugs. Instead, the duty is to warn the physician who prescribes the drug. However, OTC drugs are another story. There, manufacturers ordinarily have a duty to warn to consumer. This is especially important when the manufacturer knows of risks connected with ingestion of the OTC drug and this information is not likely to be known by the consumer.

The PDR

When drugs are prescribed, a doctor will consult the Physicians' Desk Reference for detailed information about the drug, its side effects, and interactions with other drugs. In the PDR, the doctor can learn everything necessary for the safe use of a drug. Comparison of this information, for a drug such as Cimetidine (Tagamet), demonstrates that very little is told to the consumer relative to what used to be told to the doctor. None of the information concerning "adverse reactions" is contained on the box for OTC Tagamet, while dozens are listed in the PDR.

Contra-Indications

Certain drugs can not be used in conjunction with other drugs. Thus, while a patient may be on one OTC drug, prescription of a another drug may cause harmful effects, and even death, when the two drugs are used together. Thus, when taking drugs in combination, check with your physician AND your pharmacist. They can review the PDR to make sure that you are not taking a dangerous combination of drugs. This is especially true with certain drugs like anti-depressants and also drugs for high blood pressure.

Profit Motive, Cost Savings

While OTC drugs certainly reduce the cost to consumers, they also provide a huge incentive to drug manufactures to market the beneficial effects and increase the demand and usage of their product.

This informational piece was prepared by Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.