Lefamulin, a new antibiotic to treat community-acquired bacterial pneumonia

The US Food and Drug Administration has approved a new antibiotic, lefamulin (Xenleta) to treat adults with community-acquired bacterial pneumonia. It will be available for oral (600 mg every 12 hours) and IV (150 mg every 12 hours) administration with a short 5- to 7-day course of therapy.

Lefamulin is a first-in-class semisynthetic pleuromutilin antibiotic indicated for CABP caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Adverse effects:Diarrhea, nausea, reactions at the injection site, elevated liver enzymes and vomiting. Xenleta has the potential to cause a change on an ECG reading (prolonged QT interval).

Contraindications:Patients with known hypersensitivity to lefamulin or any other members of the pleuromutilin antibiotic class, or any of the components of Xenleta; patients with prolonged QT interval, patients with certain irregular heart rhythms (arrhythmias), patients receiving treatment for certain irregular heart rhythms (antiarrhythmic agents), and patients receiving other drugs that prolong the QT interval.

Precaution:Pregnant women and women who could become pregnant should be advised of the potential risks of Xenleta to a fetus. Women who could become pregnant should be advised to use effective contraception during treatment with Xenleta and for two days after the final dose.

(Source: US FDA, Medscape)

Healthcare News Monitor

42% of patients at risk of BP misdiagnosis, says study

ET Healthworld

Mumbai: A study of 19,000 Indians has revealed that 42% of the participants were at risk of misdiagnosis as far as their blood pressure was concerned either due to “white coat syndrome” or “masked hypertension”. The Indian Heart Study, released in Mumbai on Monday, showed that 24% or 4,485 participants had white coat hypertension while another 18% had masked hypertension. “Globally, the prevalence of white coat hypertension and masked hypertension is 10-15% and 8-12%, respectively,” said New Delhi-based cardiologist Dr Upendra Kaul, main author of the study. In Mumbai, where over 1,643 patients were studied, 38.2% were at a risk of misdiagnosis due to white coat syndrome (22.8%) and masked hypertension (15.4%). Dr Brian Pinto of Holy Family Hospital, Mumbai, a coordinator for the study from Mumbai, said, “The results can have serious consequences for patients and need their attention. Some could be wrongly given medication while some may not receive it when they actually need it.” The study found the first reading in a clinic was usually wrong. While the second is better, it is still way off right reading taken at home, said doctors at a press conference held on Monday. “Another striking finding is unlike other countries, Indians seem to have higher blood pressure in the evenings than in mornings which should guide doctors to rethink the time advised for anti-hypertensive drug dosage,” said Dr Kaul.

Clinical trials may not be needed for medical devices approved, marketed in EU

Mint - Teena Thacker

The government has decided to do away with clinical trials for medical devices that have been approved and marketed for at least two years in European Union countries. The move, which is set to speed up the availability of such medical devices in India, was agreed in a recent meeting of the Drug Technical Advisory Board (DTAB), India’s top advisory body on drugs and medical devices. The Union health ministry will soon issue a notification to this effect, formalizing the decision taken at this year’s June meeting. “It is proposed to include EU in the provision specified under Rule 63(1) in the Medical Devices Rules, 2017 in respect of the waiver of clinical investigation," said the minutes of the meeting, which Mint has reviewed. The matter was taken up during the meeting of India-EU sub-commission on trade held on 6 June, 2018. “The EU side pointed out that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by regulatory authorities of the US, the UK, Australia, Canada or Japan but does not include the EU. In the view of above, it is proposed to include EU," added the minutes. The Medical Device Rules allows for an exemption in cases where the device does not have its predicate device (a legally marketed device that is not subject to premarket approval) in India before it is sold or distributed in India but has been approved by the regulatory authority in the US, the UK, Australia, Canada or Japan.

CBI arrests Deputy Drug Controller over graft charge

The Economic Times - Divya Rajagopal

The Central Bureau of Investigation on Sunday arrested Dr Naresh Sharma, Deputy Drug Controller of the Central Drugs Standard Control Organisation (CDSCO), in an attempt to crack down on the corruption in Indias drug regulating body. Dr Sharma has been suspended with immediate effect, said a press statement from the Press Information Bureau (PIB). "All stakeholders, public and officers shall take cognizance of the fact that CDSCO has the policy of zero tolerance towards corruption and is committed to act stringently against any act of corruption", the government statement said. Naresh Sharma joined the CDSCO in November 2006, from Dabur Research Foundation. His past work experiences have involved stints with Cadila Healthcare NSE 0.46 % , JK Pharmaceuticals among others. Sharma was also elected as the President of the Delhi chapter of the Indian Pharmaceutical Associatione (IPA) in 2018. IPA is an association of pharmaceutical professionals, it is not to be confused with IPA, the lobby group of top Indian generic drug makers. In his 2018 speech while elected as the Delhi President of IPA, Sharma had said that he was setting three objectives for his tenure "namely, activity, membership drive and fund generation. We need to set targets and hopefully we will achieve them.” he said this as reported by website Pharmabiz.

Bihar: Hospitals asked to ensure cleanliness

The Times of India

Patna: Cautioning hospital managers to ensure cleanliness in all public health facilities, deputy secretary State Health Society Rajesh Kumar said those who fail to do internal assessment and prepare action plan in this regard will be dealt with strictly. Their salaries can be also withheld as a disciplinary measure. The official gave the stern warning while addressing a gathering of civil surgeons, district programme managers and hospital managers at a state-level workshop on ‘Water Sanitation and Hygiene In Health (WASH)’, organized jointly by the State Health Society and Unicef here on Monday PATNA: Cautioning hospital managers to ensure cleanliness in all public health facilities, deputy secretary State Health Society Rajesh Kumar said those who fail to do internal assessment and prepare action plan in this regard will be dealt with strictly. Their salaries can be also withheld as a disciplinary measure. The official gave the stern warning while addressing a gathering of civil surgeons, district programme managers and hospital managers at a state-level workshop on ‘Water Sanitation and Hygiene In Health (WASH)’, organized jointly by the State Health Society and Unicef here on Monday.

Kondhwa resident tests positive for leptospirosis

The Times of India

Pune: A 23-year-old resident of Shivnerinagar in Kondhwa tested positive for leptospirosis on August 14. With this, the number of cases of the dreaded bacterial infection in the past two months in the city has risen to 11. The man suffered from fever, bodyache and weakness from August 7. He consulted a neighbourhood doctor for treatment. However, he did not show any improvement. His condition later worsened: he developed breathlessness from August 13. He was admitted to KEM hospital in Rasta Peth the same day. He was shifted to Critical Healthcare hospital’s intensive care unit on August 14. “The man tested positive for leptospirosis antibodies (IgM) on August 14,” a doctor from Critical Healthcare hospital in Rasta Peth said.