Friday, May 04, 2018

FDA working with manufacturers to withdraw Zinbryta from the market in the United States

Another recall, this one on Zinbryta:

On March 2, Biogen and Abbvie announced a voluntary withdrawal of Zinbryta (daclizumab), a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile. As a result, FDA 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 care professionals have the information they need to carefully transition their patients using Zinbryta to another treatment.  No new patients will start taking Zinbryta or participate in clinical studies. The company has begun notifying health care professionals and patients, and the drug will be available for patients as needed until April 30, 2018.
Patients using Zinbryta 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 1-800-456-2255 or the manufacturer’s website at www.zinbryta.comdisclaimer icon. We understand 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 Zinbryta 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 multiple sclerosis 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 only available through a restricted distribution program. FDA has continuously monitored adverse events associated with use of Zinbryta and has updated product labeling as new information became available.

Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel

Limbrel (flavocoxid 250 mg), 60 capsules

News of a recall of the product known as Limbrel. From the FDA:

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.
Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.
Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel.  It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA's health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and is now recalling Limbrel as FDA has requested.
All lots within expiry of the following products are included in this recall:
  • Limbrel (flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
  • Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
  • Limbrel (flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
  • Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16
Limbrel has been marketed since 2004 as a medical food available only by prescription for patients under active and ongoing supervision of a physician for the dietary management of osteoarthritis (OA), a degenerative disease of the joints and the most common form of arthritis. Prior to marketing, Primus conducted clinical studies that support the efficacy and safety of Limbrel and compiled an extensive dossier providing an analysis of published data to support the medical food status of Limbrel and to establish how the product meets the distinctive nutritional requirements of OA.  Primus stands by the legal status of Limbrel as a medical food. Limbrel products have been distributed nationwide in the USA to wholesalers, pharmacies, and physicians as medical foods without challenge from FDA for over 13 years, with approximately 2 million prescriptions and physician samples dispensed to an estimated 450,000 patients.

Thursday, May 03, 2018

Tasigna in the News

News across the web about Tasigna:

Tasigna (nilotinib) was approved by the U.S. Food & Drug Administration in 2007 to treat patients suffering from Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML). The medication belongs to a class of drugs called tyrosine kinase inhibitors (TKIs), which block a protein called Bcr-ABl to stop the growth of cancer cells. Since its approval, several studies have suggested that patients treated with Tasigna may be more likely to develop arteriosclerosis-related condition. For example, a 2016 study published in the American Journal of Hematology linked Tasigna to an increased risk for peripheral artery disease and sudden death.
In 2013, researchers writing in Leukemia reported that patients treated with Tasigna had higher rates of arterial disease compared to those prescribed imatinib. The Canadian label for Tasigna was updated in 2013 to note a potential risk of arteriosclerosis, after a review revealed that 277 reports of the condition had been logged with the Novartis global safety database between January 1st, 2005 and January 31, 2013. Canadian doctors were advised to closely monitor their Tasigna patients for signs of the life-threatening artery disease.
Here is the link for the Canada label changes made in 2013:

Subject: Updated information regarding the possible risk of developing atherosclerosis-related conditions with the use of TASIGNA* (nilotinib)
Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with TASIGNA* (nilotinib).
TASIGNA* is a prescription medicine used to treat adult patients at different stages of a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML).
  • Cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of TASIGNA*.
  • Patients should tell their healthcare professional if they have or have had any conditions that could cause atherosclerosis-related conditions such as a heart problem, high blood pressure, high cholesterol, or high glucose before starting TASIGNA* treatment.
  • During treatment with TASIGNA*, healthcare professionals will check for signs of atherosclerosis. Healthcare professional will also check cholesterol and blood sugar levels before starting treatment and periodically thereafter.
  • Patients should not stop treatment with TASIGNA* or change the dosage without discussing their condition with their healthcare professional.
Atherosclerosis is a disease that occurs in arterial blood vessels (arteries) and occurs more frequently in older adults. In atherosclerosis the walls of the arteries become thickened and hardened by plaque buildup. Plaque is made from fatty deposits and cells that can build up in the walls of your arteries over many years. As plaque builds up, the arteries narrow and become less flexible and the blood flow through the arteries can be reduced. Possible complications of atherosclerosis include heart attacks and strokes.