Medication Monitor

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  • December 16, 2015

    FDA approved sugammadex injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

    Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle and are used to paralyze the vocal cords when patients require tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator. 

    Safety and efficacy of sugammadex injection were evaluated in three Phase 3 clinical trials involving 456 participants. The return to recovery time was faster overall for the sugammadex treatment groups compared with the comparator groups, with most participants recovering within 5 minutes of routine use of sugammadex.

    Because of concerns about the nature and frequency of anaphylaxis (severe, potentially life-threatening allergic reaction) and hypersensitivity reactions reported in the clinical trials, sugammadex injection was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with sugammadex injection, one person had an anaphylactic reaction. Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate.

    Cases of marked bradycardia (abnormally slow heart action), some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex injection. Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.

    The most common adverse reactions reported in clinical trials included vomiting, low blood pressure, pain, headache and nausea. Doctors should also advise women using hormonal contraceptives that sugammadex injection may temporarily reduce the contraceptive effect, so they must use an alternate method of birth control for a period of time.

  • November 18, 2016

    FDA approved prasterone to treat women experiencing moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy due to menopause. It is the first FDA-approved product containing the active ingredient dehydroepiandrosterone (DHEA).

    Efficacy of prasterone, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, aged 40 to 80 years, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA.

    Women were randomly assigned to receive prasterone or a placebo vaginal insert. When compared twith placebo, prasterone was shown to reduce severity of pain experienced during sexual intercourse.

    Its safety was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

    Although DHEA is included in some dietary supplements, efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating, or preventing any disease.

  • December 22, 2015

    FDA approved selexipag tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.

    Selexipag belongs to a class of drugs called oral IP prostacyclin receptor agonists. The drug acts by relaxing muscles in the walls of blood vessels to dilate blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs.

    Safety and efficacyof the drug were established in a long-term clinical trial of 1,156 participants with PAH. Selexipag was shown to be effective in reducing hospitalization for PAH and reducing the risks of disease progression compared with placebo. Participants were exposed to selexipag in this trial for a median duration of 1.4 years.  

    Common adverse effects observed in those treated with selexipag in the trial include headache, diarrhea, jaw pain, nausea, muscle pain, vomiting, pain in an extremity, and flushing.

    Selexipag was granted orphan drug designation, which provides incentives such as tax credits, user fee waivers, and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.

  • April 30, 2015

    FDA has approved deoxycholic acid, a treatment for adults with moderate-to-severe fat below the chin, known as submental fat.

    The drug product is identical to the deoxycholic acid produced in the body that helps absorb fats. It is a cytolytic drug that physically destroys the cell membrane when injected into tissue. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.

    Deoxycholic acid injections must be administered by a licensed health professional. Patients may receive up to 50 injections in a single treatment, with up to 6 single treatments administered no less than 1 month apart. It is being provided in single patient use vials and should not be diluted or mixed with any other compounds.

    Safety and effectiveness of deoxycholic acid for treatment of submental fat were established in two clinical trials that enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive deoxycholic acid or a placebo for up to six treatments.

    The results showed that reductions in submental fat were observed more frequently in participants who received deoxycholic acid versus placebo.

    Deoxycholic acid can cause serious adverse effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing.

    The most common adverse effects include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.

    Deoxycholic acid should not be used outside of the submental area or if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.

    The agent is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, the product should not be used.

  • January 4, 2016

    FDA is cautioning that differences in dosing regimens between the two oral formulations—an oral suspension and a delayed-release tablet—of the antifungal posaconazole have resulted in dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct mg for mg substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections.

    Posaconazole is used to help prevent certain invasive fungal infections caused by Aspergillus and Candida. It is used in patients who have an increased chance of getting these infections because of weakened immune systems. The oral suspension formulation is also used to treat thrush caused by Candida in the mouth or throat area.

    Prescribers should specify the dosage form, strength, and frequency on all prescriptions they write for posaconazole. Pharmacists should request clarification from prescribers when the dosage form, strength, or frequency is not specified. Patients should talk to their health professional before they switch from one oral formulation to the other.

    Posaconazole was approved in 2006 as an oral suspension formulation. Since the approval of posaconazole delayed-release tablets in November 2013, FDA received 11 reports of the wrong oral formulations being prescribed and/or dispensed to patients. One case resulted in death, and an additional case resulted in hospitalization. According to the reports, these outcomes were a result of health professionals not knowing that the two oral formulations cannot be substituted for each other without adjusting the dose due to differences in how the medicine is absorbed and handled by the body. Posaconazole is also approved as an I.V. solution for injection. 

    In addition to changes to the outer carton of posaconazole (see photos), its manufacturer revised the prescribing information and the patient information in the drug label to alert patients and their health professionals that the two oral formulations cannot be substituted for each other.