Medication Monitor



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  • November 7, 2015

    An FDA review has determined that long-term use of the blood-thinning drug clopidogrel does not increase or decrease overall risk of death in patients with or at risk for heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.

    To investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event.

    FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.

    FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis.

    Clopidogrel is an antiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain medical conditions.

    Patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of heart attacks and blood clots. Talk with your health professional if you have any questions or concerns about clopidogrel.

    Health professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment. See the Drug Safety Communication for more information.

  • October 29, 2015

    Sanofi US is voluntarily recalling all doses of epinephrine injection currently on the market under the trade name Auvi-Q, including both the 0.15-mg and 0.3-mg strengths for hospitals, retailers, and consumers. This includes lot numbers 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery. See the Press Release for product photos.

    As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the United States and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.

    If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences, including death.

    Auvi-Q is packaged with two active devices and one trainer device in a corrugated box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies, and hospitals.

    Sanofi US is notifying its distributors and customers by letter, fax, e-mail, and phone calls and is arranging for return and reimbursement of all recalled products.

  • January 7, 2016

    Baxter International is voluntarily recalling two lots (#C980227, #C985150) of I.V. solutions to the hospital/end user level after a costumer complaint about particulate matter, which was determined to be an insect.

    The I.V. solutions are 0.9% sodium chloride injection (250 mL Viaflex plastic container), a source of water and electrolytes and also a priming solution in hemodialysis procedures; and 70% dextrose injection (2000 mL), a source of calories and water for hydration. 

    The matter was identified before patient administration, and there have been no adverse events associated with this issue reported to Baxter to date.

    Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation, and inflammation in tissues and organs.

    The recalled lots were distributed to customers and distributors in the United States between June 6, 2015, and December 16, 2015. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between the hours of 7 am and 6 pm, Central Time.

  • August 22, 2012

    Nephron Pharmaceuticals announced the launch of racepinephrine inhalation aerosol for temporary relief of bronchial asthma in patients 4 years and older. This OTC product is an alternative to the discontinued epinephrine inhalation aerosol (Primatene Mist Inhaler) which was removed from the market in December 2011 because of its CFC propellant.

    The product will be available in a starter kit that includes 10 vials and the EZ Breathe Atomizer. A refill package including 30 vials will be marketed as well. The EZ Breathe Atomizer is an OTC device that sprays liquid medication in aerosol form into the air for a patient to inhale.

  • February 1, 2016

    FDA has approved elbasvir and grazoprevir with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

    Safety and efficacy of elbasvir and grazoprevir with or without ribavirin were evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received the combination drug with or without ribavirin once daily for 12 or 16 weeks. The studies were designed to measure whether a participant’s HCV was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response [SVR]), suggesting a participant’s infection had been cured.

    The overall SVR rates ranged from 94% to 97% in participants infected with genotype 1 and from 97% to 100% in participants infected with genotype 4 across trials for the approved treatment regimens. To maximize SVR rates for patients, the product label provides recommendations on length of treatment with or without ribavirin specifically tailored to the characteristics of the patient and his or her virus. Health professionals should screen genotype 1a–infected patients for certain viral genetic variations before starting treatment with elbasvir and grazoprevir to determine dosage regimen and duration.

    The most common adverse effects of elbasvir and grazoprevir without ribavirin were fatigue, headache, and nausea. The most common adverse effects with ribavirin were anemia and headache.

    The product carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of clinical trial participants, generally at or after treatment week 8. Liver-related blood tests should be performed before starting therapy and at certain times during treatment. The agent should not be given to patients with moderate or severe liver impairment.

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