Photo Credit: 123RF/Stock Photo[/caption] Patients and consumers often assume that, if their doctor prescribed a medication or an over-the-counter drug is on store shelves, it must be safe. Right? Not necessarily. In some cases, a prescription or over-the-counter medication may have obtained FDA approval, but risky side effects or potential dangers are discovered after it has gone to market. In other instances, drug companies urge doctors to prescribe a drug for an unapproved use – an illegal practice known as “off-label marketing.” And sometimes the FDA’s own procedures might be to blame. For instance, an article in Think Progress discusses the dangers of the FDA’s drug approval process:
“An expedient drug-approval process may have led to an increase in warnings, recalls, and reports of side effects in prescription medication, a recent study suggests. The study, published in the August issue of Health Affairs, examined the records of drugs approved before and after the passage of the Prescription User Drug Fee Act (PUDFA), a 1992 law that sped up the drug approval process using fees collected from pharmaceutical companies.
Researchers found that the rate of warning or withdrawal increased by five percentage points among medications approved after 1992, when PUDFA went into effect. The findings have prompted calls for the federal government to strengthen the drug approval process.”
Some patient and consumer advocates are recommending a stricter drug approval process and stronger safety standards. “New drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval,” researchers told Medscape Medical News. “We believe that the ultimate solution is stronger U.S. drug approval standards. In the interim, with the rare exception of truly breakthrough therapies, doctors should preferentially prescribe drugs that have been on the market longer and hence have a more established track record of safety.” Lax drug safety standards and questionable marketing practices by drug companies have opened the door to liability and class action lawsuits. For instance, as we reported, the City of Chicago is considering a lawsuit against the makers of narcotic painkillers. According to The New York Times, in anticipation of a possible lawsuit, the City of Chicago is investigating whether manufacturers of narcotics overstated their benefits and understated their risks. Similarly, in 2013, health care giant Johnson & Johnson (J&J) and its subsidiaries agreed to pay more than $2.2 billion in criminal and civil fines to resolve allegations that the company committed off-label marketing practices in connection its prescription drugs Risperdal, Invega, and Natrecor. The Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish are committed to protecting the public from dangerous medical products, including unsafe pharmaceuticals and defective medical devices. If you have been injured by an unsafe medicine or defective medical device, contact the Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish to schedule a free consultation to discuss a possible product liability or medical malpractice claim. Additional Information:
- JOHNSON & JOHNSON AGREES TO PAY $2.2 BILLION TO SETTLE CHARGES INVOLVING ITS DRUG RISPERDAL
- CHICAGO CONSIDERS LAWSUIT AGAINST MAKERS OF NARCOTIC PAINKILLERS
- COMMON MEDICATION ERRORS
Steinberg Goodman & Kalish (www.sgklawyers.com) is dedicated to protecting victims and their families. We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (888) 325-7299 or (312) 445-9084.