Raplon

Raplon is an intravenous medication administered by hospitals or other surgical facilities to act as a muscle relaxant for the placement of breathing tubes during surgery.

Why Prescribed

Raplon is administered as a muscle relaxant to patients before hospital or surgical procedures.

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FDA Approved Uses

Raplon was approved by the FDA in 1999 as a skeletal muscle relaxation medication for tube insertion into trachea and endotracheal intubation in C-Section operations.

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Side Effects

The most common side effect associated with Raplon use is breathing problems.

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Warnings and Alerts

In March of 2001, Organon, Inc., the manufacturer of Raplon, voluntarily withdrew the product from the market because it may have been linked to 5 deaths and 90 other problems related to bronchospasm (an inability to breathe normally).

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Drug Contraindications

Raplon is contraindicated in patients who are hypersensitive to rapacuronium.

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FAQ's

What did the Organon "Dear Health Care Professional" letter state?

An excerpt from the letter included the following:
“In light of the recent safety issues raised, regarding Raplon and its possible association with the occurrence of bronchospasm, we are voluntarily withdrawing the product. We feel a strong responsibility to the clinicians that not only use our products, but also entrust the lives of their patients on the reliability of these products. Our primary concern and goal in this endeavor is to ensure the safety of each patient. The RAPLON® package insert lists bronchospasm as an adverse event which occurred in 3.2% of patients in premarketing clinical trials. We have now received reports of several serious adverse bronchospasm events including a few unexplained fatalities.
The Food and Drug Administration (FDA) was notified immediately of this decision and the planned market withdrawal of all unused product.”

Why did the FDA approve Raplon in the first place?

Before Raplon was approved, there were reports of bronchospasm in clinical trials but they were considered to be no different than what would be expected in the general population.

What is pharmaceutical product liability?

Product liability is a legal term used to describe a special duty the law imposes on all manufacturers, including pharmaceutical companies. A person injured by some hidden defect in a product while using the product for its intended purposes does not have to prove the manufacturer was negligent in order to receive financial compensation. In fact, even with proof that the manufacturer was not negligent and could not have foreseen the product defect that caused the injury, a legal claim for compensation may still remain valid.

This rule (sometimes called "strict liability" or "absolute liability,") has more to do with social policy than with purely legal matters. The idea behind it is to avoid placing the risk of catastrophic loss on an individual consumer. The manufacturer can purchase insurance to cover such claims, increasing the price of the manufactured product to cover the cost of insurance. In this way, the risk of catastrophic loss is divided among all purchasers of the product.

Can I file a lawsuit if I have been injured as the result of using Raplon?

Patients injured by unsafe products are ordinarily entitled to recover monetary damages for all losses and expenses suffered from use of the product. Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

• Past and future medical expenses
• Past and future pain and suffering
• Lost wages
• Loss of future earning capacity
• Emotional distress

If you have been injured from using Raplon, particularly if you have experienced breathing difficulties, you have legal rights and should contact a qualified defective drug litigation attorney to discuss your legal claim. As all legal claims are subject to time limits, known as statute of limitations, you may risk forfeiture of your right to financial compensation if you delay.

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