World Pharma News

More prescription ranitidine recalled from shelves

More prescription ranitidine recalled from shelves

By Anna Smith

The Medicines and Healthcare Regulatory Agency (MHRA) has issued a drug alert, as Creo Pharma Limited and Tillomed Laboratories have recalled their unexpired stock of prescription-only ranitidine.

GSK’s formulation of the drug, called Zantac and used for heartburn and stomach ulcers, was recalled in the USA last month after the US Food and Drug Administration (FDA) found “unacceptable” levels of carcinogen in the medicine due to a possible contamination with N-nitrosodimethylamine (NDMA).

The federal agency released a statement alerting patients to the possible contamination, after investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year.

NDMA, the chemical in question, is classified as a “probable human carcinogen”, based on results from laboratory tests. It is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables.

The UK recall has affected ranitidine Oral Solution 30mg/ml produced by Creo Pharma Limited, and ranitidine 150mg Tablets, produced by Tillomed Laboratories.

The regulatory agency has demanded healthcare professionals stop supplying the products immediately, and that all remaining stock should be quarantined and returned without delay to the supplier.

psalidi

It did, however, advise that patients should not stop taking their medication, and a treatment review is not necessary until the next routine appointment.

The MHRA has “requested risk assessments from the relevant companies which will include the testing of potentially affected batches.”

Dr Andrew Gray, MHRA deputy director of inspections, enforcement & standards also confirmed that “Currently, there is no evidence that medicines containing nitrosamines have caused any harm to patients, but the Agency is closely monitoring the situation, and working with other Regulatory Agencies around the world.”

The MHRA is actively involved with the European Medicines Agency (EMA) and other medicines’ regulators to determine the impact of what is now an ongoing, global issue

ΠΗΓΗ

Διαβάστε όλες τις τελευταίες Ειδήσεις για την υγεία από την Ελλάδα και τον Κόσμο

Διαβάστε Eπίσης:

Hardo Fischer exclusively on healthweb: Gene therapies introduce new therapeutic model in Medicine

‘AeroNabs’ promise powerful, inhalable protection against COVID-19

The Health Economy: A Strengthening and Stabilizing factor for Economic Development

Dr. Emmanuel Alexandrakis is a Global Market Strategist at the WifOR Institute, a German independent Economic Research Organization, and Adjunct Professor at the MBA International Program of the Athens University of Economics and Business for Health Sector Strategy. The recent global crisis, that was triggered by the COVID-19 pandemic, underlined the importance of investing in the health sector. The unprecedented effects of this global pandemic, […]

How risky is it to attend a Trump campaign rally during a pandemic?

As the coronavirus plows through the United States, health experts worry President Donald Trump’s campaign rally in Tulsa, Oklahoma, will become a new hotspot for coronavirus infections. Leaders and public health experts have expressed concern, including Dr. Anthony Fauci, the nation’s top infectious disease expert, as well as Bruce Dart, the director of Tulsa’s health […]

Trump officials deflect blame for US death toll, escalate reopening push

Analysis by Stephen Collinson, CNN N)Two of President Donald Trump’s top officials are now pointing the finger at the administration’s own scientists and Americans’ pre-existing health conditions to explain the country’s world-leading Covid-19 death toll. Health and Human Services Secretary Alex Azar suggested Sunday that underlying health conditions, including among minorities, were one reason for the high American […]

Coronavirus Q&As for Consumers

The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about treatments and prevention:   Q: Are antibiotics effective in preventing or treating COVID-19?   A: No. Antibiotics do not work against viruses; […]

Trump bans export of coronavirus protection gear, says he’s ‘not happy with 3M’

President Donald Trump on Friday invoked the Defense Production Act to ban “unscrupulous actors and profiteers” from exporting critical medical gear used to protect wearers from the coronavirus. The president unveiled the new order amid a dispute with U.S. manufacturing giant 3M, which had warned the Trump administration that halting its exports of respirator masks could make them even […]

WHO warns of global medical equipment shortage as world braces for coronavirus spread

Countries worldwide are preparing for the possibility of public health emergencies related to the novel coronavirus, as the World Health Organization warned a shortage of protective equipment is hampering the response to the outbreak. The virus has infected more than 92,800 people and killed at least 3,200 since it was first identified in the Chinese […]

Scottish Academy launches ‘bold’ strategic priorities

by Anna Smith The Academy of Medical Royal Colleges and Faculties in Scotland (the Scottish Academy) has published its strategic priorities to 2023, outlining a focus on collaborative working between the different medical professions in Scotland, to “improve quality of care for patients.” The Academy, which promotes and co-ordinates the work of the Medical Royal Colleges […]

MHRA updates Dysport license to include upper limb spasticity in children

By Anna Smith The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Ipsen a licence update for Dysport (abobotulinumtoxinA), extending the use of the drug to focal spasticity of upper limbs in paediatric cerebral palsy (CP) patients, two years of age or older. The regulatory body says that the approval was based on a […]