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FDA issues black box warning for opioid painkillers to curb overdose, addiction risks

The Food and Drug Administration has announced that it will require a “black box” warning on the most widely prescribed class of opioid painkillers in an effort to curb the epidemic of fatal overdoses linked to these drugs. The new FDA warning will be required for all immediate-release opioid painkillers, including combination pills that combine opioid medications with non-prescription drug ingredients.

Opioid painkillers are some of the most widely prescribed medications in the U.S. Combination opioids such as Vicodin and generic brands were prescribed about 135 million times in 2012. Opioid medications such as oxycodone, hydrocodone, fentanyl, and morphine generated sales of $9 billion in 2015 for drug companies such as Teva Pharmaceuticals, Janssen Pharmaceutical, and Purdue Pharma.

The increased use of opioids drugs has led to skyrocketing numbers of cases of addiction and overdoses caused by these drugs. Since 1999, more than 165,000 patients in the U.S. have died as a result of an opioid overdose, including a record 28,647 deaths in 2014, the most recent year for which records are available.

The new warnings instruct doctors that immediate-release opioids should only be used as a last resort to treat severe pain when other medications don’t work or can’t be taken by a patient. Updated prescribing information for opioid medications will contain information about how these drugs can be safely prescribed to patients, including guidelines about how to monitor patients to limit the risk of dependency, abuse, and addiction.

The FDA’s new black box opioid warning is part of a growing effort by the federal government to curb the side effects of opioid painkillers. Three years ago, the FDA announced that it would require a black box warning on extended release opioid medications similar to the warning announced recently for immediate-release opioids. Recently, the Centers for Disease Control and Prevention also announced that it was issuing new treatment guidelines to physicians about opioid painkillers in order to reduce the number of unnecessary prescriptions written for these medications and the number of addiction and overdose cases caused by them.

The new black box warning will apply to more than 200 short-acting opioid drugs, according to a spokesperson for the agency. These medications including commonly prescribed brand names such as Vicodin and OxyContin, as well as numerous generic formulations of opioid drugs.

The FDA warning about opioid medications will also contain information about the risks of prescribing painkillers to pregnant women. According to the FDA, the chronic use of immediate release opioid painkillers among pregnant women can lead to painful withdrawal symptoms in newborns known as Neonatal Opioid Withdrawal Syndrome. Experts estimate that about 14% of pregnant women have been prescribed opioid painkillers.

Lawsuits Filed On Behalf of Opioid Overdose Victims

If you or a loved one has been the victim of an overdose or other serious complications caused by opioid overprescription, you may be eligible to file a lawsuit against manufacturer of the drug, or the doctor or hospital that was responsible for your injuries. The first step in taking legal action is to talk with a law firm with the experience and knowledge to successfully handle your case from start to finish.

The overprescription of prescription painkiller medications has caused disastrous consequences for patients who developed addictions or suffered overdoses due to their use of these drugs. For years, the drug industry has aggressively promoted opioid medications to physicians, regardless of the health consequences their use may have for patients. Doctors who indiscriminately prescribe these opioid medications to patients have also contributed to the growing epidemic of prescription painkiller overdoses in the U.S.

The lawyers at Heygood, Orr & Pearson have represented numerous individuals who have suffered overdose, addiction, or other complications from opioid painkiller prescriptions. Our law firm has handled more cases involving the fentanyl pain patch—a powerful painkiller about 80-100 times more powerful than morphine—than all other law firms in the country combined. Our firm has both the training and experience to prosecute medical malpractice cases involving a wide array of other serious opioid painkillers, including Vicodin, hydrocodone, OxyContin, oxycodone, methadone, hydromorphone, and other medications.

If you or a loved one has been hurt by side effects from opioid painkiller medications, the lawyers at Heygood, Orr & Pearson are ready to help. For more information about filing a lawsuit and to learn if you may be eligible to file a case, contact our law firm by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form located at the top of this page and answering a few simple questions to get started.

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