Medication Monitor

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Generic Name (Trade Name—Company)
  • March 13, 2019

    FDA approved a new generic valsartan in response to a recent shortage resulting from multiple recalls of generic valsartan products from several manufacturers after certain lots of valsartan and other ARB medicines were found to contain nitrosamine impurities.

    The agency is also working closely with manufacturers to see if they can produce additional supplies of these medications. FDA scientists are using the information learned from an investigation to evaluate all ARBs currently on the market and will also apply this information when assessing future applications to ensure that the manufacturing process can’t form these impurities.

    For this approval, FDA evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the new generic valsartan does not contain NDMA or NDEA. FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.

    FDA continues to investigate ARB medicines that contain nitrosamine impurities and that do not meet the agency’s quality standards. The agency will continue to update the lists on its website of recalled valsartan, losartan, and irbesartan products as more information becomes available from ongoing testing. If patients take an ARB drug product, they should check the lists periodically, as information may change. Not all ARB medicines have been recalled.

    Valsartan treats high blood pressure and heart failure. Its most common adverse effects are dizziness, hypotension, hyperkalemia, and increased blood creatinine.

  • March 7, 2019

    Heron Therapeutics announced FDA approval of aprepitant injectable emulsion beyond the previous administration method (a 30-minute I.V. infusion) to include a 2-minute I.V. injection for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in adults. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent substance P/neurokinin-1 receptor antagonist to significantly reduce CINV in both the acute phase (0–24 h after chemotherapy) and the delayed phase (24–120 h after chemotherapy).

    The recommended dosage for I.V. injection following highly emetogenic cancer chemotherapy (single-dose regimen) is 130 mg on day 1. Following moderately emetogenic cancer chemotherapy (3-day regimen), the dosage is 100 mg on day 1, with aprepitant 80 mg capsules given orally on days 2 and 3. Treatment with the agent is part of a regimen that includes a corticosteroid and a 5-hydroxytryptamine receptor antagonist.

    The most common adverse reactions with the 3-day oral aprepitant regimen in conjunction with MEC were fatigue and eructation. The most common adverse reactions with the single-dose I.V. fosaprepitant regimen in conjunction with HEC were generally similar to that seen in prior HEC studies with oral aprepitant. Infusion-site reactions also occurred.

    The most common adverse reactions with single-dose aprepitant were headache and fatigue. The safety profile of aprepitant in healthy participants who received a single 2-minute injection was similar to that seen with a 30-minute infusion.

  • March 6, 2019

    Methylphenidate hydrochloride extended-release (XR) capsules CII, a central nervous system stimulant, offers a methylphenidate treatment option with a longer duration of efficacy in patients with ADHD aged 6 years and older. The product will be available in six capsule strengths: 25, 35, 45, 55, 70, and 85 mg.

    The recommended starting dose is 25 mg taken orally once daily in the morning, with or without food. The dose should be titrated in increments of 10 mg to 15 mg at intervals of no less than 5 days. Capsules may be taken whole or opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt.

    The most common adverse reactions in adults are insomnia, dry mouth, and decreased appetite; in pediatric patients, they are decreased appetite, insomnia, and decreased weight.

    The prescribing information contains a boxed warning for abuse and dependence. Health professionals should assess the risk of abuse before prescribing the drug and monitor patients for signs of abuse and dependence. The drug is contraindicated in patients with a known hypersensitivity to methylphenidate or product components, as well as patients receiving concurrent treatment with a MAOI or those who have used an MAOI within the preceding 14 days.

  • March 5, 2019

    FDA approved colchicine oral solution, 0.6 mg/5 mL, for prophylaxis of gout flares in adults.

    Physicians have used colchicine to treat gout for decades, but they are often required to adjust the dose or interrupt treatment to address drug interactions or health conditions such as when patients are undergoing kidney dialysis. Compared with currently available capsule and tablet formulations of colchicine, the oral solution allows health care providers to easily make dosage adjustments for their patients, the manufacturer stated in a news release. The oral solution is also beneficial for patients who cannot swallow solid doses or pills. About 15% of older adult patients have difficulty swallowing and therefore require liquid formulations.

    The new formulation will be available in summer 2019.

  • March 5, 2019

    Janssen announced FDA approval of guselkumab (Tremfya One-Press) as a single-dose, patient-controlled injector for adults with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody that selectively blocks the protein interleukin (IL)-23.

    Tremfya One-Press is administered as a 100-mg S.C. injection once every 8 weeks after starter doses at weeks 0 and 4. It is intended for use under the guidance and supervision of a physician, but patients may self-inject after physician approval and proper training. 

    The injector fits comfortably in the hand and offers a controlled injection that hides the needle throughout the process, stated Janssen in a news release. The device allows patients to control the rate and pressure of their injection. A soft click indicates when administration is complete, and a safety system protects the needle after use.

    The most common adverse effects are upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.