Defective Over-The-Counter Medication

Many people think that over-the-counter (OTC) medication is safer than prescription drugs. On one level, they are correct: According to the U.S. Food and Drug Administration (FDA), “OTC drugs are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional.” Yet, just because they have been found by the FDA to be relatively safe does not mean that OTC drugs are defect-free.

In fact, thousands of people are injured every year by defective over-the-counter drugs. Potential problems that can make OTC drugs
dangerous drugs include:

  • The wrong medication: Drug manufacturers have been known to mix drugs accidentally. In 2012, for example, Swiss drugmaker Novartis recalled certain bottles of its popular Bufferin, Gas-X, Excedrin and NoDoz drugs because there were errors in bottle packaging that caused some bottles to contain pills from other medications.
  • Unsafe bottles: Novartis also recalled numerous OTC medications, including Triaminic Syrup, Jack & Jill pediatric syrups and TheraFlu cough syrups, at the beginning of 2013 because the child-resistant caps could fail, posing serious risks to children.
  • Unsafe drug manufacturing: Unsafe drugs can also come in batches, the result of manufacturing problems. In 2010, more than 40 varieties of Johnson & Johnson’s pediatric medicine – including Tylenol, Benadryl, Zyrtec and Motrin – were recalled because they potentially contained metal particles or too much of the active or inactive drug ingredients.
  • Drug interactions: Failure to adequately warn about drug interactions presents a significant problem to OTC drug manufacturers. Serious injuries and fatalities can occur when consumers mix certain OTC drugs with other OTC or prescription medications.
  • Unknown consequences: More and more often, we hear about manufacturers that have not fully tested drugs before rushing them to market. Even drugs that have been tested for years can have unknown consequences. For example, recent studies have shown that ibuprofen, when taken in high doses, can increase a patient’s risk of heart attack.

So how can you protect against defective or dangerous over-the-counter drugs? Be vigilant. Read warning labels, take drugs as directed and watch for recalls. Look at your pill before popping it into your mouth to ensure that it matches other pills in the bottle, and seek medical attention immediately if you begin to react to the medication.

Of course, many of the thousands of Americans who are injured or killed by dangerous drugs each year have no control over the adverse reactions they experience. If a drug has been inadequately tested or packaged incorrectly or if the warning labels do not do enough to protect consumers, the manufacturer can and should be held accountable.

This is especially true when an OTC medication causes birth injuries.

Birth Injuries Caused by Over-The-Counter Medication

Certain over-the-counter medications have also been linked to birth defects. Because drug manufacturers cannot test their drugs on pregnant women, new drugs often enter the market without clear warnings about pregnancy risks. In fact, according to a 2011 study, 91 percent of all drugs approved by the FDA “had insufficient data to determine the risk of using the medication during pregnancy.” (CDC)

For that reason, pregnant women must be extra vigilant when choosing over-the-counter drugs and should speak with their doctors before taking any medication.

Certain salicylates (such as normal to high-dose aspirin), for example, have been linked to neonatal hemorrhaging, prolonged labor and increased perinatal mortality. Even common drugs like Pepto-Bismol, Advil and Aleve are not recommended at certain points in pregnancy.

When adequate warnings are present and pregnant women do not follow those warnings, they will have trouble holding the drug companies accountable for birth defects. Many injured women and their families, however, have been able to bring lawsuits against drug companies for failing to warn of pregnancy risks.

Injured by an OTC Drug?

If you have been injured by an OTC drug, you may be entitled to compensation for your injuries and other economic and noneconomic losses. Whether or not the drug that caused your injury has been voluntarily recalled, the company that manufactured that drug may be held accountable through a product liability/dangerous drug lawsuit. Learn more about your options for recovery by contacting an experienced product liability lawyer

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