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FDA Drug Recalls & Warnings

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In the past 20 years, an explosion of innovation and technology has led to the creation of groundbreaking prescription drugs that are meant to treat everything from high cholesterol to obsessive-compulsive disorder. But many of these drugs have taken a serious and risky turn: they can cause debilitating side effects that can have long-term consequences or even lead to death.

Prescription drugs, often thought to undergo stringent safety testing and strict oversight, have put thousands of patients at risk with unforeseen side effects, from cancer to heart attacks and strokes to suicide.

Rushed To Pharmacy Shelves

While many consumers depend on the U.S. Food and Drug Administration (FDA) to police drug manufacturers, the fact is that the FDA has little enforcement power. Many consumers also falsely believe that prescription drugs undergo rigorous testing before being put onto pharmacy shelves. In reality, most prescription drugs are rushed through the approval process and only undergo minimal premarket testing. Most side effects aren't detected until a full seven years after the drug has hit the market. The prescription drug companies wield a surprising amount of power over the direction of their new drugs.

Prescription Drug Dangers

The problems with many of the prescription drugs begin with the FDA but ultimately fall on the drug manufacturers. The FDA is under pressure to hasten the approval process, pushing drugs through the process despite safety concerns. The FDA can't force a drug company to do research, so consumer advocates and watchdogs accuse the drug companies of taking advantage of the situation.

Post Approval Concerns

Once a drug has been released, it's up to the drug manufacturers and physicians to report any problems to the FDA Adverse Event Reporting System (FAERS), a centralized database that is supposed to monitor problematic drugs. Research shows that less than 10 percent of all unwanted side effects are reported to FAERS.

Vetting Your Prescription Drugs

Even with these lax standards, most consumers depend on the FDA to uphold safety criteria. However, the bottom line is that drug manufacturers brandish more power, leaving consumers at their mercy. The average patient who has been injured by a prescription drug has little recourse. That's where the court system steps in.

Taking The Drug Manufacturers To Court

Large-scale prescription drug litigation can accomplish many things that individual consumers cannot. Not only can a winning lawsuit hit drug manufacturers in the pocketbook, where it hurts the most, it can bring unwanted attention to the drug dangers. Drug companies spend millions a year on advertising campaigns to make their drugs look good; large-scale litigation can balance the scales, bringing much needed attention to the drug's dangers.

Prescription Drug Warnings

Once a prescription drug has been approved, the FDA lacks the enforcement power and legal authority to make any changes to its drug label. Certainly, the FDA can request the manufacturer make the change. But the company doesn't have to follow through. In most cases, violating FDA regulations are simply misdemeanor crimes.

Stricter Enforcement

In cases of egregious violations, typically the U.S. Department of Justice has to step in. Such was the case in 2012, when GlaxoSmithKline plead guilty and paid $3 billion to resolve federal criminal and civil inquiries regarding the company's Paxil and Wellbutrin medications. Many prescription drug companies consider the fines as the cost of doing business.

What Is A Black-Box Warning?

A boxed warning is intended to be the FDA's most stringent warning to consumers about a drug's side effect. But even with these notorious warnings, drug companies hold the upper hand. The FDA cannot force a company to include a warning if the company doesn't feel it is merited.

Prescription Drug Recalls

For many consumers, the term recall elicits images of a prescription drug being banished from the market. Typically, however, that doesn't happen. Most often, questionable prescriptions must undergo label changes in a recall.

Types of FDA Recalls

The FDA has several levels of prescription drug and medical device recalls, depending on the potential for harm. Recalls can take place by the company's own initiative (voluntary recall), by FDA request or by the FDA's statutory authority:

  • Class I -- There is reasonable probability that the use or exposure to the product will cause adverse health consequences or death. In 2013, the FDA issued a Class I recall of dialysis treatments NaturaLyte and GranuFlo for their link to fatal heart attacks.
  • Class II -- Exposure to or use of the product can cause temporary or medically reversible health problems.
  • Class III -- Exposure to the product is not likely to cause medical concerns.
  • Market Withdrawal -- A company voluntarily and temporarily removes a product to correct a violation.
  • Medical Device Safety Alert -- Issued when medical devices can cause serious harm.

Pharmaceutical Company Response

Except in the cases of infant formulas and medical devices, the FDA cannot force pharmaceutical companies to recall a product. If a company refuses to recall the product, the FDA can warn the public, seize the drugs already on the market and stop the company from further distributing them. In extreme cases, the FDA can seek court action to bar a manufacturer from distributing the medication.

FDA Notice Not Necessary

When a manufacturer decides to recall a product, the company does not have to tell the FDA. In many cases, pharmaceutical companies prefer not to label the drug's problems as a recall because of potentially bad publicity. Instead, many companies conduct a recall under the FDA radar.

With the FDA's meager enforcement powers and the growing power of the pharmaceutical companies, many injured patients have been turning to the court system. If you or a loved one has been injured by a prescription drug, turn to us for help. Don't allow the pharmaceutical companies to wield any more power. It is time for the consumers to take back control.

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