5 Highlights from the Pharmacy World This Week
In case you missed it, here's the hottest news in pharmacy this week:
In case you missed it, here’s the hottest news in pharmacy this week:
1. Hepatitis C virus medications carry a new black box warning.1
The FDA is now requiring the majority of the direct-acting antiviral (DAA) medications used for HCV to include a new black box warning about the risk of reactivation in patients who have a current or previous hepatitis B virus (HBV) infection and are currently taking DAA medications for HCV. The FDA found 24 cases of HBV reactivation from November 22, 2013, to July 18, 2016. Some patients experienced serious adverse effects such as liver complications and even death. This new warning will be included on all medication guides. The FDA is urging all health care providers to monitor patients on DAA treatment for HBV.
List of affected HCV drugs:
- Daklinza (daclatasvir)
- Epclusa (sofosbuvir, velpatasvir)
- Harvoni (ledipasvir, sofosbuvir)
- Olysio (simeprevir)
- Sovaldi (sofosbuvir)
- Technivie (ombitasvir, paritaprevir, ritonavir)
- Viekira Pak (dasabuvir, ombitasvir, paritaprevir, ritonavir)
- Viekira Pak XR (dasabuvir, ombitasvir, paritaprevir, ritonavir)
- Zepatier (elbasvir, grazoprevir)
2. Brilinta (ticagrelor) is no more effective than clopidogrel in patients with peripheral artery disease (PAD).2
In 2009, ticagrelor’s PLATO trial demonstrated that it had better mortality rates and less adverse events compared to clopidogrel in patients with acute coronary syndrome. Ticagrelor had high hopes of dominating this market, but a few days ago, AstraZeneca announced ticagrelor’s phase 3 clinical trial (EUCLID) results, which was one of the largest cardiovascular outcomes trials performed exclusively in PAD patients. EUCLID compared ticagrelor 90 mg twice daily to clopidogrel 75 mg daily in 13,885 patients in 28 countries for the prevention of atherothrombotic events such as cardiovascular death, heart attack, and ischemic stroke. Ticagrelor failed to meet the primary endpoint of the trial and was no more effective than clopidogrel.
3. Patients suffering from eczema have hope!3
Earlier this week, dupilumab’s 2 phase 3 clinical trials’ (SOLO 1 and SOLO 2) results were published. Dupilumab was used in adults with moderate to severe atopic dermatitis who were inadequately controlled by topical treatment. Patients receiving dupilumab were seen to have reductions in pruritus and symptoms of depression and anxiety, and improved quality of life. However, researchers stated that there should be larger and longer studies to assess the safety and effectiveness of long-term use of dupilumab. Sanofi and Regeneron plan to launch dupilumab in March 2017.
4. FDA warns against homeopathic teething tablets and gels.4
The FDA issued a warning about the potentially harmful effects homeopathic teething tablets and gels may have on infants and children. The FDA urges all consumers to immediately stop using these medications. In 2010, it was reported that these homeopathic teething tablets and gels might cause seizures. The FDA neither evaluates nor approves any homeopathic medications and there’s a significant lack of scientific data for all homeopathic medications. Teething can be managed without prescription or OTC medications. Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels—or after any other medication or shot.
5. Get your flu shot!5
The CDC worries that flu vaccination rates may decline this year since AstraZeneca’s FluMist is no longer offered due to its poor efficacy in children aged 2 to 17 years. It was estimated that 20 million people in the US received the FluMist with a large proportion being children. FluMist was an attractive option to children because a nasal spray is clearly more preferred than a needle. Last year, 60% of children received a flu vaccine—the highest rates of vaccination in all age groups. The CDC hopes to raise the overall flu vaccination rate higher than last year’s 45.6%. If the vaccination rate were to increase by 5%, it would reduce illness by 800,000 and hospitalizations by 10,000. It’s our job as pharmacists to advocate for flu vaccines.
- FDA. FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. www.fda.gov/Drugs/DrugSafety/ucm522932.htm.
- AstraZeneca. AstraZeneca reports top-line results from the Brilinta EUCLID trial in patients with peripheral artery disease. astrazeneca.com/media-centre/press-releases/2016/astrazeneca-reports-top-line-results-from-the-brilinta-euclid-trial-in-patients-with-peripheral-artery-disease-04102016.html.
- Simpson EL, et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. New England Journal of Medicine. 2016. nejm.org/doi/full/10.1056/NEJMoa1610020#t=article.
- Meyer L. FDA warns against the use of homeopathic teething tablets and gels. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm.
- Sagonowsky E. As AZ works to assess FluMist efficacy woes, CDC worries flu vaccination rates could slip. fiercepharma.com/vaccines/as-az-works-to-assess-flumist-efficacy-woes-cdc-worries-flu-vaccination-rates-could-slip.