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  • Regulatory NewsRegulatory News

    FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children

    The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18. “We are taking this action after conducting an extensive review and convening a  panel of outside experts . Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and dea...
  • Regulatory NewsRegulatory News

    Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling

    Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine . For years the US has been in the grips of a prescription drug abuse epidemic, in part driven by the availability of hydrocodone and other opioids such as oxycodone, codeine and methadone. In 2013, more than 200 million prescriptions for opioids we...
  • Regulatory NewsRegulatory News

    DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers

    In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law. The move follows an October 2013 recommendation by the US Food and Drug Administration (FDA), which also recommended that the drugs be regulated as Schedule II products under the Controlled Substances Act (CSA), a 1970 law which places controls on substances known to be dangerous, prone to ...
  • FDA: State, Federal Efforts to Reduce Access to Zohydro 'Extremely Troubling'

    Since the US Food and Drug Administration (FDA) approved Zogenix's non-abuse-deterrent pure hydrocodone painkiller Zohydro ER (hydrocodone bitartrate) in October 2013, groups opposed to the drug have proposed a number of ways to overrule the agency's approval order and remove the drug from the market. Legislators have called for FDA to reconsider. They've called for the government to investigate the approval. They've called for the Department of Health and Human Services...
  • Legislators Call for Government Investigation Into Industry Influence on FDA Approval of Painkiller

    As pressure continues to mount on the US Food and Drug Administration (FDA) over its October 2013 decision to approve a controversial pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), several legislators are trying to convince the government itself to launch an investigation into the matter. Background: What is Zohydro? FDA approved Zohydro in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory commi...
  • FDA Declares Mission (Almost) Accomplished on Removal of High-Dose Acetaminophen Products

    More than three years after initially asking all manufacturers of acetaminophen to voluntarily withdraw products containing more than 325 mg of the drug, the US Food and Drug Administration (FDA) is declaring mission (almost) accomplished. Background In January 2011, FDA requested that manufacturers discontinue marketing high-dose versions of acetaminophen-defined as doses higher than 325 mg-due the drug causing severe liver failure in some patients. "Overdose from pr...
  • Pressure Mounts on FDA to Reconsider Approval of New Painkiller

    A group of legislators in the House of Representatives have become the latest group to introduce legislation that would seek to specifically ban a new hydrocodone painkiller recently approved by the US Food and Drug Administration (FDA)-an action some critics say would undermine the regulator's authority and set a dangerous new precedent. Background FDA approved Zohydro ER (hydrocodone bitartrate) in October 2013. The approval decision was seen by many as surprising, as...
  • Senator Looks to Bypass FDA and Remove Zohydro With Legislation

    A US senator is calling for the US Food and Drug Administration's (FDA) to ban a recently approved pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), not through a letter or request, but by legislation. Background FDA approved Zohydro ER in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory committee meeting at which a majority of the committee members voted against approving the drug, citing its pot...
  • Attempt to Strengthen Restrictions on Hydrocodone Products Clears Second-to-Last Hurdle

    The Drug Enforcement Administration (DEA) has released a proposed rule that adopts a recommendation by the US Food and Drug Administration (FDA) to reschedule combination hydrocodone products as Schedule II substances under the Controlled Substances Act (CSA) . Background In the US, access to opioid-based painkiller medications has long been the topic of a contentious debate. On one side have been patient advocates and some doctors, who say opioids should be easily ava...
  • Love and More Powerful Drugs: Senate Minority Leader Slams FDA Decision on Hydrocodone Product

    It may be Valentine's Day in the US, but it's safe to say that some of the Senate's most prominent members don't love a decision recently made by the US Food and Drug Administration (FDA). On 12 February 2014, Sens. Mitch McConnell (R-KY), Tom Coburn (R-OK) and Lamar Alexander (R-TN) wrote to FDA Commissioner Margaret Hamburg demanding answers and "accountability" for the agency's October 2013 decision to approve Zohydro, a pure hydrocodone product. Background The...
  • FDA Looks to Reassess Hydrocodone Products

    The US Food and Drug Administration (FDA) is planning to revisit a benefit:risk assessment for a powerful painkiller subject to escalating amounts of addiction and abuse after the agency was pressed by a national drug control agency. In an 8 June Federal Register posting, FDA said it had been petitioned by the US Drug Enforcement Agency (DEA) to look at how the government classifies hydrocodone, which is subject to restrictions under the Controlled Substances Act (CSA...