Category: Medical
Aquilon nebulisers – CE mark withdrawn and supply ceased, but many have remained on the market
Despite withdrawal of the CE safety marking for Aquilon series of nebulisers, manufactured by AFP Medical, the nebulisers have still been placed on the market. A number of devices may have been sold despite the withdrawal of the CE marking, which means the safety of the product cannot be guaranteed.
CE safety certification is vital for consumer and supplier confidence in a product, and when it comes to medical products, such approval – or withdrawal, as is the case here – can be even more important.
Continue Reading…
UK government investigating the scale of harm caused by vaginal mesh implants
Our legal team have been assisting people in various situations involving harm caused by vaginal mesh implants.
The UK government review update is welcome news.
Years after the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) investigated issues and decided against recalls and bans, the National Institute for Health and Clinical Excellence (NICE) has suggested the surgery should be banned, and New Zealand have become the first country in the world to put an outright ban in place.
Continue Reading…
Birth defects reportedly caused by in-utero exposure to Epilepsy Drug
A drug that helps control epileptic seizures has been reportedly linked to birth defects and should not be used by pregnant women or women of child-bearing potential.
Depakote was created by French pharmaceutical drug company Sanofi back in 1967. The British equivalent, Epilim, has been available since 1973.
The drug has been used around the world and has gained regulatory approval for treatment of epilepsy, with variations of the drug introduced in 1995 for bipolar manic episodes, and in 1996 to prevent migraines. But, a generation later, it has been revealed the drug can cause severe birth defects at a significantly high percentage.
Continue Reading…
PharmaTech LLC packs up manufacturing plant after its liquid drugs are found to be contaminated with B.Cepacia bacteria
All of PharmaTech LLC’s liquid drugs made at one manufacturing plant have been recalled, with regulators advising consumers not to use them.
Reportedly, the drugs have been contaminated with Burkholderia cepacia bacteria.
Patient infections have been linked to the drugs, meaning regulators are warning against the use of their products. Notably, this is not PharmaTech’s first brush with the law. Regulators have been involved with them three times in less than a year for similar issues involving the bacteria.
Continue Reading…
MHRA issue “Class 4” drug alert warning for Focus Pharmaceuticals after barcode errors found on 8 medicinal products
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Class 4 (caution in use) warning over eight Focus Pharmaceutical medicinal products after a problem was found with the barcodes.
The packaging fault may interfere with prescriptions as the wrong product may be identified when they’re scanned.
The medicines themselves have no reported faults and the rest of the packaging including the name, strength and pharmaceutical form of the medicine is correct as far as the manufacturer and the MHRA are aware.
Continue Reading…
Suicide statistics may have allegedly been incorrectly reported in drug trials
GlaxoSmithKline (GSK) is currently engaged in a fierce legal battle over its antidepressant pill, Paxil (Seroxat in the U.K.).
Marketed as an antidepressant, Paxil is supposed to reduce the risk of suicide in users.
When it was first made for production, GSK conducted clinical trials to test how effective the drug was. In 1989, it presented the drug to regulators along with the results that indicated Paxil was much safer than taking a placebo.
Continue Reading…
Medtronic recalls disposable diabetes infusion sets over risk of causing hypoglycemia
Medical device manufacturer Medtronic Plc is recalling disposable diabetes infusion sets as a possible defect may trigger excessive doses of insulin to the diabetic user, putting them at risk of hypoglycemia.
The recall reportedly affects insulin infusion sets distributed all over the world.
The device, connected to an insulin pump, features thin plastic tubing with a needle or cannula at the end to carry insulin into the body when needed. However, apparently, “one in every two million” sets may contain a “complication”.
Continue Reading…
NICE calls for U.K. surgery ban on vaginal mesh implants
The infamous mesh implants that’s sewn into vagina walls which has reportedly caused multiple injuries and excruciating pain for many women may now be finally banned for good in the U.K.
Those women who had the ‘minor’ routine surgery to help treat organ prolapses and mild incontinence, but then went on to suffer serious and painful complications has prompted the U.K.’s National Institute for Health and Care Excellence (NICE) to recommend that the implants shouldn’t be used in treatment any more at all, only for research.
This is a change to previous NICE guidelines that were more about taking extreme precautions when using the mesh devices.
Continue Reading…
Hospitals and Doctors warned over using Intercept Pharmaceuticals liver disease drug
Regulators have issued Doctors and Hospitals with a warning over Intercept Pharmaceuticals liver disease drug after 19 people have reportedly died after taking too much of it.
Regulators also noted 11 cases of serious liver injury after taking the drug as well.
The warning prompted the company’s shares to reportedly plummet down by 24.9%, to $73.70. The drop is thought to be the company’s biggest loss since November 2014, Bloomberg reports.
Continue Reading…
Class 4 drug alert for Kyowa Kirin Bleo-Kyowa Powder Solution
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for the Bleo-Kyowa powder over a ‘minor’ defect being reported.
The agency cites glass particles being detected in a batch of the medicine back in April 2017.
Hospitals, pharmacies and other healthcare providers are requested to take caution in using the Bleomycin Sulphate powder that acts as an anticancer chemotherapy medicine.
Continue Reading…
Ceftazidime antibiotic concentration may deteriorate if stored at the wrong temperature
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a medical device alert over the test disc for the antibiotic ‘Ceftazidime’, warning that storing the test discs at the wrong temperature can increase the chances of false resistance results.
The antibiotic is used to treat all sorts of bacterial infections including joint infections, sepsis, pneumonia, urinary tract infections and more. In cases where the Ceftazidime test disc was not frozen between the temperatures of +2o and -20o, notably at +8o, the antibiotic’s shelf-life may have been degraded.
Continue Reading…
Thousands of patients sue 3M for allegedly causing infections
Over 4,000 patients reportedly contracted serious infections after using 3M’s warm air blower blanket post-operation that has allegedly deposited infectious bacteria into their incisions.
Most of the patients reportedly underwent joint surgery and used the blanket to keep warm during the procedure. The deep-joint infections have reportedly caused septic arthritis in some cases. The inflammation of a joint through infection can be very painful and cause swelling, requiring treatment with anti-biotics.
Continue Reading…