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Affected person Develops Glandular Tularemia After Taking Care of Sick Cat

Posted in News on 12th October 2018

October 11, 2018

A recent case published in the New England Journal of Medicine reports on a patient diagnosed with glandular tularemia, an infection that was likely transmitted by his cat.

The 68-year-old patient reported having a fever for 1 week followed by progressive, painful swelling on the right side of his neck for 2 months. The symptoms had started 2 days after his outdoor cat had died from what was believed to be feline leukemia, however laboratory testing had not been conducted to confirm the diagnosis.

Image courtesy of The New England Journal of Medicine ©2018.

During the physical examination, it was noted that the patient had 3 erythematous, tender lymph nodes. Serologic testing was conducted and revealed the patient was positive for Francisella tularensis, a Gram-negative coccobacillus that is transmitted to humans by infected animals. “Domestic cats can become infected through the consumption of infected prey and can transmit the bacteria to humans,” explained the authors. The patient reported he had been administering medication to his cat at the time of its illness.

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Depending on how the bacteria enter the body, the signs and symptoms of tularemia can vary and illness can range from mild to life-threatening. The most common form of tularemia is ulceroglandular, in which case a skin ulcer appears at the site of bacterial entry. Glandular tularemia is similar to ulceroglandular tularemia but without the presence of an ulcer. Antibiotics used to treat tularemia include streptomycin, gentamicin, doxycycline, and ciprofloxacin.

Within 5 days of receiving doxycycline, the patient’s lesions improved; resolution of symptoms occurred within 3 weeks of treatment (the patient was treated for a total of 4 weeks).

For more information visit NEJM.org.

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Affected person Develops Acquired Hemophilia After Remedy With Levofloxacin

Posted in News on 28th September 2018

September 27, 2018

Her total recuperation time was approximately 3 months

Her total recuperation time was approximately 3 months

A recent report published in the Journal of Pharmacy Practice describes the case of a 75-year-old female patient who developed acquired hemophilia following levofloxacin administration and then subsequently required anticoagulation therapy for acute coronary syndrome.

The study authors reported that the patient initially developed bruising on her neck and lips after initiation of oral levofloxacin for the treatment of an upper respiratory tract infection. Although discontinuation of the medication resolved the patient’s symptoms initially, spontaneous bruising recurred and progressed over several weeks, prompting the patient to seek medical attention for persistent bruising in her upper extremities.

“Her coagulation studies showed a fibrinogen of 424mg/dL (normal range: 150-400mg/dL), an undetectable factor VIII level (normal range: 55%-200%), and a factor VIII inhibitor titer of 30.4 BU (normal range: 0 U),” the study authors stated.

The patient was administered recombinant factor VIIA 90mcg/kg every 6 hours until her bleeding subsided. Her labs began to normalize on day 18 of admission and she was started on a weekly regimen of rituximab 375mg/m2 administered intravenously for 4 weeks and subsequently discharged. It was noted that she only completed 3 doses of rituximab due to insurance issues. It was reported that the patient’s labs were completely normalized 52 days post-admission and that her total recuperation time was approximately 3 months. “This case study presents a probable adverse drug reaction associated with levofloxacin as quantified by the Naranjo probability scale with a score of 7,” the authors noted.

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A few years later, the same patient presented with chest pain and ST-segment elevation for which she received unfractionated heparin, ticagrelor 180mg, and aspirin 325mg before bare metal stent placement. Her labs showed normal factor VIII levels of 158% and while a factor transfusion was initially considered prior to percutaneous coronary intervention (PCI), it was ultimately not completed in order to avoid a delay in treatment. The patient had some bruising at the catheter site, but otherwise there were no further bleeding or bruising episodes; she was discharged and initiated on low-dose aspirin, ticagrelor, atorvastatin, lisinopril, and metoprolol. The patient was also advised to discontinue ibuprofen use.

“In our patient, the normal factor VIII levels of 158% suggested that the acquired hemophilia had resolved upon the most recent presentation,” explained the authors. They added that for patients with acquired hemophilia undergoing PCI, “proper coagulation studies should be obtained and corrected prior to initiating therapy.”

Reference

Mor LT, Holley K. A Case Report of Anticoagulation Management in Acquired Hemophilia Associated With Levofloxacin. Journal of Pharmacy Practice. 2018. https://doi.org/10.1177/0897190018799186

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Inveltys Accepted for Publish-Op Ache, Irritation After Ocular Surgical procedure

Posted in News on 27th August 2018
Inveltys is the first ocular steroid approved for twice-daily dosing for this indication

Inveltys is the first ocular steroid approved for twice-daily dosing for this indication

Kala announced that the Food and Drug Administration (FDA) has approved Inveltys (loteprednol etabonate) 1% ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery. 

Inveltys is the first ocular steroid approved for twice-daily dosing for this indication; other ocular steroids are approved for 4 times daily dosing. Inveltys utilizes the Company’s proprietary Mucus-Penetrating Particle (MPP) technology to improve penetration into target tissues of the eye. The technology has demonstrated a greater delivery of the drug into ocular tissues vs current loteprednol etabonate-containing drugs. 

Data from two Phase 3, multicenter, randomized, double-masked, placebo-controlled trials showed a greater proportion of patients treated with Inveltys having complete resolution of ocular inflammation at Day 8 (24% vs 13%) and Day 15 (50% vs 27%), and complete resolution of pain at Day 4 (43% vs 25%), Day 8 (56% vs 36%), and Day 15 (69% vs 48%) vs placebo (P for both <.01). In addition, treatment was well-tolerated with no treatment-related serious adverse events reported. 

Inveltys will be available as a 1% suspension in 5mL bottles. It is anticipated to launch in the beginning of 2019.

Viagra in being pregnant trial stopped after 11 new child infants died

Posted in News on 1st August 2018

A Dutch clinical trial was looking at the potential of Sildenafil or impotence drug Viagra to improve the growth in unborn babies of pregnant women. The study had to be stopped prematurely after the death of eleven babies.

Sildenafil is capable of improving the blood flow. In the clinical trial the team of researchers tried to use the drug to improve the blood flow to the placenta of the pregnant women. These participating pregnant women had poorly developed placenta that caused retardation of overall growth in the fetus. However when administered with Viagra the babies died because the drug causes fatal damage to the lungs of these unborn babies. A detailed investigation is underway to examine the cause of the deaths. Meanwhile authorities have stated that there has been no wrong doing in the trials.

There have been earlier smaller clinical trials in Australia, New Zealand and UK where Viagra had been administered to pregnant women with poorly developed placenta and fetal growth retardation. No harm was seen to the participating mothers in those studies. However Viagra failed to provide any extra benefits in these mothers. Thus in 2010 it was felt that the drug in these scenarios should be used only in clinical trials.

At present there are no treatments for fetal growth retardation due to poorly developed placenta in the mother. These babies are usually born prematurely and have a low birth weight. They have a poor chance of survival. This trial was an attempt to develop a medication that could prolong the gestational period till the baby is well grown and increase the body weight of the baby. This medication could save lives, felt the researchers.

For this study the Dutch researchers included participants who would be recruited for the study up until 2020 and the study would be carried out in 11 hospitals in the Netherlands, one of which is the Amsterdam University Medical Centre. The study began in 2015 and a speculated 350 patients were to be recruited. For this phase of the study 93 women were included and they were all administered Sildenafil. Another 90 women were included in the trial as controls and they were given a placebo drug or dummy.
After delivery it was noted that twenty babies developed lung complications. Of these three were in the placebo group and 17 were from the Sildenafil treated group. Eleven of the sick babies in the sildenafil group died of the lung complications. Eight other babies in the sildenafil treated group died of unrelated complications. Of the three babies in the placebo group that developed lung complications, none succumbed to the illness. Nine babies in the placebo group died due to unrelated causes. An independent committee looked at the study outcome and last week the study was terminated prematurely.

Prof Zarcko Alfirevic, from the University of Liverpool, was part of the UK team. He said that this result from the Dutch study is “unexpected” and more is to be found on the underlying mechanism of the deaths in the babies. “It needs a thorough investigation because the complications were not seen in the two other, similar trials that have already been done in the UK and Australia and New Zealand,” he said.

Wessel Ganzevoort, lead researcher and a gynaecologist said that the last thing they wanted is to harm the patients and they are shocked with the results. He said that their team has informed Canadian researchers who are conducting a similar study and instructed them to stop their research.

Source:

https://www.amc.nl/web/nieuws-en-verhalen/actueel/actueel/onderzoek-gestaakt-met-medicijn-tegen-groeivertraging-ongeboren-baby-.htm

Posted in: Drug Trial News

Tags: Baby, Birth Weight, Blood, Clinical Trial, Impotence, Lungs, Newborn, Placebo, Placenta, Pregnancy, Research

Coronary heart Meds Recalled After Discovery of Attainable Carcinogenic Impurity

Posted in News on 17th July 2018
Not all valsartan-containing medications are part of this recall

Not all valsartan-containing drugs are a part of this recall

A number of drugs containing the energetic ingredient valsartan are being recalled after the Meals and Drug Administration (FDA) introduced that these medicine comprise N-nitrosodimethylamine (NDMA), an impurity categorised as a possible human carcinogen. 

The recalled drugs embrace Valsartan Tablets manufactured by Main Prescription drugs, Solco Healthcare, and Teva Prescription drugs, in addition to Valsartan/Hydrochlorothiazide Tablets from Solco Healthcare and Teva Prescription drugs. “We have now fastidiously assessed the valsartan-containing drugs offered in the US, and we have discovered that the valsartan offered by these particular firms doesn’t meet our security requirements,” mentioned Janet Woodcock, MD, director of the FDA’s Heart for Drug Analysis and Analysis. “For this reason we have requested these firms to take instant motion to guard sufferers.” 

As valsartan is used to deal with numerous cardiovascular situations together with coronary heart failure and hypertension, sufferers ought to proceed to take their drugs till they’ve a substitute product. Not all valsartan-containing drugs are a part of this recall; sufferers ought to contact the pharmacy that distributed the remedy to see if the drug got here from lots particularly manufactured by an organization talked about above.

Healthcare professionals are urged to report any potential unwanted effects associated to this recall to the FDA’s MedWatch Program. Within the meantime, the Company plans to proceed its investigation into the potential results NDMA might need on sufferers who’ve been taking these merchandise. Addressing a potential scarcity due the recall, FDA Commissioner Scott Gottlieb, MD, mentioned “As we search the removing of sure drug merchandise at this time, our drug shortages crew can also be working onerous to make sure sufferers’ therapeutic wants are met in the US with an ample provide of unaffected drugs.”