Medication Monitor

SORT BY:      Most Recent      Most Viewed     
List-View      Table-View
Generic Name (Trade Name—Company)
  • May 2, 2019

    FDA has approved Dengvaxia, the first vaccine for prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3, and 4) in people aged 9 through 16 years who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given 6 and 12 months later.

    Dengue disease is the most common mosquito-borne viral disease in the world and is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands. The first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu or another viral infection. A subsequent infection can lead to severe dengue, including dengue hemorrhagic fever, a more severe form of the disease that can be fatal. Symptoms may include stomach pain, persistent vomiting, bleeding, confusion, and difficulty breathing. Approximately 95% of all severe/hospitalized cases of dengue are associated with second dengue virus infection. Because there are no specific drugs approved for treatment of dengue disease, care is limited to managing the symptoms.

    Safety and effectiveness of the new vaccine were determined in three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America, and the Asia Pacific region. The vaccine was determined to be approximately 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals aged 9 through 16 years who previously had laboratory-confirmed dengue disease. Dengvaxia has already been approved in 19 countries and the European Union.

    The most commonly reported adverse effects by those who received Dengvaxia were headache, muscle pain, joint pain, fatigue, injection-site pain, and low-grade fever. The frequency of adverse effects was similar across Dengvaxia and placebo recipients and tended to decrease after each subsequent dose of the vaccine.

    Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. This is because in people who have not been infected with dengue virus, Dengvaxia appears to act like a first dengue infection—without actually infecting the person with wild-type dengue virus—such that a subsequent infection can result in severe dengue disease. Health professionals should evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not been previously infected by dengue virus. This can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing prior to vaccination.

  • May 2, 2019

    Sagent Pharmaceuticals announced a voluntary nationwide recall of one lot (#M813513) of ketorolac tromethamine injection USP 60 mg/2 mL (30 mg per mL) because microbial growth was detected during a routine simulation of the manufacturing process. This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent. 

    Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.

    The product is a NSAID indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. It is supplied in 2-ml glass tubular vials. The lot number being recalled was distributed to hospitals, wholesalers, and distributors nationwide from January to March 2019.

  • May 1, 2019

    FDA approved glecaprevir and pibrentasvir tablets to treat all six genotypes of hepatitis C virus (HCV) in children aged 12 to 17. The combination drug was previously approved to treat HCV in adults in 2017.

    With this approval, dosing information is provided for treatment of adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of six identified HCV genotypes either without cirrhosis or with compensated cirrhosis.

    Safety and efficacy of glecaprevir/pibrentasvir for use with pediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis. Results demonstrated that 100% of patients who received the drug for 8 or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.

    In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or genotype 5 or 6 HCV infection, safety and efficacy are supported by previous studies observed in glecaprevir and pibrentasvir in adults. The adverse reactions observed were consistent with those observed in clinical studies in adults.

    Treatment duration differs depending on treatment history, viral genotype, and cirrhosis status.

    The most common adverse reactions are headache and fatigue. The agent is not recommended for treatment of patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

    Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV-coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with glecaprevir/pibrentasvir.

  • May 1, 2019

    FDA is warning that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than with other prescription medicines used for sleep.

    If patients experience a complex sleep behavior during which they engage in activities while they are not fully awake, or do not remember activities they have done while taking the medicine, they should stop taking their insomnia medication and contact their health professional right away.

    Health professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Health professionals should advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death, and they should discontinue taking these medicines if they experience an episode of complex sleep behavior.

  • May 1, 2019

    AmEx Pharmacy is voluntarily recalling one lot (#190212AB, BUD 5/13/2019) of bevacizumab 1.25 mg/0.05 mL 31G injectable to the consumer/user level. The monoject syringe of this product may become difficult to express, and the additional force needed to express the drug product could result in damage to the eye while the needle is in the eye. 

    The product is used for wet age-related macular degeneration and diabetic retinopathy. It is individually wrapped and labeled in a Tyvek pouch, which is then placed in a labeled amber bag to protect from light. The lot number appears prominently on all labeling. The lot was distributed to ophthalmologist clinics in Pennsylvania, Illinois, Texas, Wisconsin, Kansas, Tennessee, Indiana, and Arizona.

    To date, AmEx Pharmacy has received three reports, two of which resulted in an adverse drug event.