FDA warning recommends new prescription rules on Vicodin and other hydrocodone painkillers

by Michael Heygood

Prescriptions for drugs containing hydrocodone—a type of prescription opioid painkiller present in commonly prescribed, potentially addictive drugs such as Vicodin—may soon face new, tighter regulations. The FDA classifies and regulates prescription drugs based on their medical use and their potential for abuse and addiction. The FDA has announced that it will recommend hydrocodone-containing painkillers be reclassified as Schedule II drugs. The change would impose new restrictions on how such drugs are prescribed and used. Schedule II drugs are those with the highest potential for abuse that can be legally prescribed. Current Schedule II drugs include painkillers like methadone, fentanyl and oxycodone, the active ingredient in OxyContin.

Over the past several years, the FDA has been evaluating and weighing the appropriate use of opioid analgesic drug products. Explaining that “in recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States,” the FDA has now announced it will recommend that hydrocodone combination products be reclassified as Schedule II drugs.

The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab. The change would reduce the number of refills patients could get before going back to see their doctor. IT would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription. Patients would also be required to take a prescription to a pharmacy, rather than have a doctor call it in.

When doctors and hospitals fail to exercise proper care when prescribing opioid medications, they may be putting the health—and even the lives—of their patients at risk. Patients who are given painkillers that are more powerful than what is needed to treat their symptoms, or who are given large prescriptions with more pills than necessary, are more likely to suffer an accidental overdose or to become addicted to their medications. In other cases, opioid medications such as fentanyl can be prescribed with other drugs that depress the central nervous system, leading to a combined drug overdose.

Heygood, Orr & Pearson fights for painkiller overdose victims

If you or a loved one has been the victim of complications from an opioid overdose, the doctor or hospital who prescribed these drugs may be to blame. Many doctors who prescribe strong painkillers to their patients have little experience with pain management, causing them to prescribe drugs that are too powerful or in doses that exceed what a patient requires. Sadly, many of these mistakes end in addictions, overdoses, or deaths that could have been prevented.

Heygood, Orr & Pearson has represented numerous clients who have been the victim of complications from excessive painkiller prescriptions by doctors or hospitals. The attorneys at our law firm have handled more cases involving the fentanyl pain patch—a powerful opioid painkiller about 100 times more potent than morphine—than all other law firms in the country combined.

Our partners—Jim Orr, Eric Pearson, and myself—have each been chosen by their peers as Super Lawyers in the state of Texas for several years in a row.* Our firm has also been given the highest possible rating for law firms by Martindale-Hubbell, the nation’s leading law firm rating service.

For more information about opioid painkiller lawsuits and to find out if you are eligible to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by filling out the free case evaluation form located at the top of this page.


Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.