FDA Recommends Restricting Access to Hydrocodone Painkillers

Drugs containing hydrocodone, such as Vicodin, may soon face tighter restrictions, as recommended by the U.S. Food and Drug Administration (FDA). Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances, but the FDA is now recommending that the drugs be reclassified as Schedule II products like other opioid painkillers, such as oxycodone and morphine.

A reclassification of hydrocodone painkillers would make them harder to obtain since doctors are not allowed to call in a prescription for a Schedule II product to a pharmacy and, instead, patients must present a written prescription at the pharmacy. Additionally, the reclassification would require patients to see their doctors before obtaining a refill.

The FDA’s recommendation of reclassification comes at the urging of the Drug Enforcement Administration (DEA), which is currently battling prescription drug abuse. Before the FDA’s reclassification recommendation can be finalized, the change must be approved by the Department of Health and Human Services and the DEA.

Proponents of the reclassification argue that the measure is necessary in order to curb the number of deaths caused by prescription drug abuse, pointing out that nearly three of four prescription drug overdoses are caused by opioid pain-killers, according to data from the Centers for Disease Control and Prevention. Furthermore, according to the U.S. Centers for Disease Control and Prevention (CDC), the misuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009 –nearly double the amount just five years ago.

Unsafe Drug Liability

Drug manufacturers, doctors, and pharmacists all have an obligation to ensure that the drugs they make and deliver to patients are safe. When a doctor or pharmacist fails to fulfill his or her duty to provide adequate care to a patient, he or she can be liable in a medical malpractice lawsuit. On the other hand, if the drug manufacturer makes an unsafe pharmaceutical product, it can be held liable in a product liability lawsuit.

Not only do drug manufacturers have an obligation to make sure that the pharmaceuticals they are producing are safe, but they must also make sure that they contain adequate warning labels. As we reported earlier this year, a jury awarded a young girl and her parents $63 million in compensatory damages (plus an additional $46 million in interest and costs) for severe adverse reactions the girl suffered after taking Children’s Motrin. The medicine’s maker, Johnson & Johnson, was found liable for failing to provide adequate warning labels about potential adverse reactions.

Moreover, doctors are obligated to ensure that the drugs that they are prescribing to their patients are safe, effective, and appropriate for the patient. If the doctor continues to prescribe potentially addictive painkillers, such as Vicodin or Oxycotin, to a patient who is suspected of abusing the drug, the doctor could be held liable in a medical malpractice lawsuit.

The Chicago medical product liability attorneys at Cogan & Power are dedicated to protecting consumers from unsafe pharmaceuticals and dangerous medical devices. If you have been injured or a loved one has died as a result of an unsafe drug or a defective medical device, please contact our office at (312) 477-2500 to schedule a free consultation to discuss a possible product liability or medical malpractice lawsuit.