Medication Monitor

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  • March 26, 2018

    Biogen and AbbVie are voluntarily withdrawing daclizumab, a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile.

    FDA announced it is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States and to ensure that health professionals have the information they need to carefully transition their patients using daclizumab to another treatment. No new patients will start taking daclizumab or participate in clinical studies.

    The company has begun notifying health professionals and patients, and the drug will be available for patients as needed until April 30, 2018.

    Patients using daclizumab should not stop their medication without talking with their doctor and should contact their doctor immediately if they have any new and unexplained symptoms. Any questions or concerns about the withdrawal can be directed to the manufacturers’ service center at 800-456-2255 or the manufacturer’s website at www.zinbryta.comdisclaimer icon. FDA stated that it understands that this may be a difficult situation for some patients and will continue to work closely with the manufacturers throughout the withdrawal process.

    The complex safety profile of daclizumab has been recognized since the time of FDA approval. The drug’s safety profile led to an indication of use generally limited to patients who have had an inadequate response to two or more MS drugs, to a boxed warning about the risk of liver injury and of other immune-mediated disorders, and to a Risk Evaluation and Mitigation Strategy making the drug available only through a restricted distribution program.

    FDA has continuously monitored adverse events associated with use of daclizumab and has updated product labeling as new information became available.

    Recently, the European Medicines Agency announced a recall of daclizumab following 12 reports of serious inflammatory brain disorders worldwide. FDA is aware of these reports and is conducting a review of similar events. As the manufacturers move forward the withdrawal plan, any additional important information will be made available to the public. 

    FDA asks health professionals and consumers to report any adverse reactions or quality problems to FDA’s MedWatch program at

  • June 13, 2017

    On June 8, 2017, FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal because of concerns that the benefits of the drug may no longer outweigh its risks.

    This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale because of the public health consequences of abuse.

    FDA’s decision was based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).

    This decision follows a March 2017 FDA advisory committee meeting in which a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.

    Opana ER was first approved in 2006 for management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

    While the product met the regulatory standards for approval, FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market.

    FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. In the interim, FDA is making health professionals and others aware of the particularly serious risks associated with abuse of this product.

    FDA said it will continue to examine the risk–benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of its response to this public health crisis.

  • January 27, 2017

    A District Court judge has ordered Sanofi and Regeneron Pharmaceuticals to take alirocumab (Praluent), a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, off the U.S. market.

    Amgen filed suit in October 2014 seeking a stop to Sanofi and Regeneron selling alirocumab, claiming infringement on its patent for a similar agent, evolocumab (Repatha). A jury found in favor of Amgen in March 2016. Sanofi and Regeneron then moved to have a judge overturn that ruling, but on January 5, 2017, Judge Sue L Robinson denied that motion.

    Both Praluent and Repatha facilitate the removal of LDL from the blood by blocking PCSK9. Compared with placebo, Repatha reduced LDL by approximately 60%, while trial participants taking Praluent had an average reduction in LDL ranging from 36% to 59%.

    Sanofi and Regeneron immediately issued a statement confirming their intention to appeal, noting that alirocumab will continue to be available in the interim.

  • December 5, 2012

    The 32-mg single I.V. dose of ondansetron has been pulled from the market, FDA announced yesterday, because of concerns related to cardiac adverse events. In June, the agency warned that the 32-mg dose should be avoided because of the risk of QT interval prolongation, which can lead to torsade de pointes. Preliminary results of a study ordered by the FDA found a maximum mean difference in QTcF of 20 ms after the 32 mg intravenous dose, compared with a QTcF difference of 6 ms for the 8 mg intravenous dose.

    FDA noted that removal of the 32-mg dose should not contribute to a potential ondansetron shortage, as this dose only made up a small percentage of the current market. The agency also noted that it will continue to recommend an I.V. regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. Oral ondansetron was also discussed as an effective alternative for the management of chemotherapy-induced nausea and vomiting.

  • October 5, 2012

    FDA has released an update reporting that Budeprion XL 300 mg is not therapeutically equivalent to GlaxoSmithKline’s Wellbutrin XL 300 mg. This update is based on data from an agency-sponsored study which concluded that Budeprion XL 300 mg tablets failed to release bupropion into the blood at the same rate and to the same extent as the branded product. FDA conducted this study in response to numerous reports that patients who switched from Wellbutrin XL 300 mg to the generic product were experiencing reduced efficacy.

    Based on these data, Impax has requested that the FDA withdraw approval of Budeprion XL 300 mg extended-release tablets and has stopped shipping the product. In addition, it has issued detailed information to patients about this product withdrawal. This update does not apply to the 150-mg dose of Budeprion XL or to the other four generic bupropion extended-release products made by other manufacturers.

    FDA noted that it has not conducted bioequivalence studies of the other four generic versions of Wellbutrin XL 300 mg, but has recently asked each of the other manufacturers—Anchen, Actavis, Watson, and Mylan—to conduct their own studies to assess the bioequivalence of their 300-mg extended-release bupropion tablets to Wellbutrin XL 300 mg. Data from these studies are to be submitted to the agency no later than March 2013.

    Patients taking Budeprion XL 300 mg as a substitute for Wellbutrin XL 300 mg should talk with their health provider if they have questions about taking this medication, the agency advised.