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    UK's MHRA Puts New Restrictions on Popular Painkiller

    A widely used over-the-counter painkiller has been reclassified as a prescription-only medicine (POM) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). In a press release on 14 January 2015, MHRA announced that patients will now need a prescription to purchase diclofenac oral tablets. The agency cited concerns over “increased risk of serious cardiac side effects in some patients,” which is worsened by long-term or high-dose use. The decision to re...
  • Senators Press FDA to Explain Regulation of Generic Opioids

    A group of senators are pressing the US Food and Drug Administration (FDA) to provide a more predictable pathway to market for generic opioid painkillers in the hopes of ensuring that new versions of the drug will retain the abuse-deterrent qualities of the existing products. Background FDA's policies on generic opioid painkillers have always been a bit wonky on account of the agency needing to balance two competing factors: policy and law. On one hand, the agency want...
  • 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...
  • Development of Painkillers Focus of New FDA Draft Guidance

    Extensive new draft guidance released this week by the US Food and Drug Administration (FDA) makes formal recommendations on how sponsors of analgesic painkillers should develop their products in preparation for eventual marketing authorization. The 35-page draft guidance, Analgesic Indications: Developing Drug and Biological Products , is intended for sponsors of analgesic products intended to treat acute, chronic and breakthrough pain. All three types of pain-acute...
  • FDA Finalizes Boxed Warning for Codeine Product Associated with Pediatric Deaths

    US regulators have announced that prescription codeine will now be required to contain a boxed warning contraindicating its use in children who have just undergone a tonsillectomy procedure, saying that deaths and injuries have occurred after some children ultra-rapidly metabolized the drug into morphine. FDA's 20 February 2013 warning follows a preliminary one made in August 2012, in which it said that the drug has been associated with the deaths of at least three chi...
  • OTC Topical Pain Relievers Can Cause Dangerous Reactions, Say Regulators

    Regulators with the US Food and Drug Administration (FDA) have sent out a warning to consumers indicating that over-the-counter topical pain relievers such as BENGAY and Icy Hot have in some cases led to dangerous skin reactions. After receiving numerous reports of consumers suffering mild to severe chemical burns from products containing menthol, methyl salicylate or capsaicin, FDA said it had combed its adverse event reporting databases and found 43 cases in which a ...
  • Genetic Predisposition to Codeine Overdose Potentially Fatal to Children, Warns FDA

    A popular painkiller may put children recovering from surgical procedures at greater risk for serious and potentially fatal side effects, the US Food and Drug Administration (FDA) said Wednesday, 15 August. The agency said it concerned about codeine -a painkiller commonly used after children have their tonsils or adenoids removed-and reports in scientific literature indicating at least three children may have died after taking the painkiller in a post-operative setting....