Bactroban is a skin product produced by GSK for the treatment of Impetigo and other types of skin problems. Last year (2015) GSK ordered a recall of almost half a million Bactroban tubes due to contamination of the product (with Penicillin and other substances) in the manufacturing process (it is produced at GSK’s Worthing site in the UK). According to FiercePharma (who have done great work in their reporting of this, and other GSK ‘incidents’) :
“….the U.K. drugmaker is recalling 427,513 tubes of its Bactroban (mupirocin calcium) cream and Bactroban Nasal Ointment in different sizes. Mupirocin calcium cream is an antibiotic used to treat skin infections such as impetigo.
GSK said it voluntarily initiated the recall of the 22 lots after it was discovered that the API for the product was potentially contaminated with penicillin and foreign substances during manufacturing process….”
According to the FDA website (on guidance and compliance regulations), cross-contamination with Penicillin has the potential to be quite dangerous.
Yes, penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people. Differences in the chemically substituted 6-aminopenicillanic acid side chain can generate allergic reactions ranging from skin rashes to life-threatening anaphylaxis.
Anaphylaxis is a potentially life threatening reaction from a Penicillin allergy. Although the life threatening Anaphylaxis reaction is rare, sensitivity, in general- to Penicillin- is not.
According to the NHS website-
The most common side effects of antibiotics affect the digestive system. These occur in around 1 in 10 people.
Side effects of antibiotics that affect the digestive system include:
- nausea (feeling like you may vomit)
- bloating and indigestion
- abdominal pain
- loss of appetite
These side effects are usually mild and should pass once you finish your course of treatment.
If you experience any additional side effects other than those listed above, you should contact your GP or the doctor in charge of your care for advice.
Antibiotic allergic reactions
Around 1 in 15 people have an allergic reaction to antibiotics, especially penicillin and cephalosporins. In most cases, the allergic reaction is mild to moderate and can take the form of:
- a raised, itchy skin rash (urticaria, or hives)
- tightness of the throat, which can cause breathing difficulties
These mild to moderate allergic reactions can usually be successfully treated by taking antihistamines.
But if you’re concerned, or your symptoms don’t respond to treatment, you should call your GP for advice. If you can’t contact your GP, call NHS 111.
In rare cases, an antibiotic can cause a severe and potentially life-threatening allergic reaction known as anaphylaxis.
Initial symptoms of anaphylaxis are often the same as above and can lead to:
- a rapid heartbeat
- increasing difficulty breathing caused by swelling and tightening of the neck
- a sudden intense feeling of apprehension and fear
- a sharp and sudden drop in your blood pressure, which can make you feel light-headed and confused
- falling unconsciousness
Anaphylaxis is a medical emergency and can be life-threatening if prompt treatment isn’t given. Dial 999 immediately and ask for an ambulance if you think you or someone around you is experiencing anaphylaxis.
If GSK have recalled up to half a million tubes of Bactroban last year, then how many people were put at risk of a Penicillin reaction? The life threatening Anaphylaxis can occur in one in 5000/10.000 doses, therefore were roughly 100 people at risk from this most severe side effect, and if so then how many were at risk from the less severe ones?
It seems like a lot of people were potentially put at risk…
Those who follow GSK related news would be aware that GSK have had compliance issues in their manufacturing process for decades now.
Who could forget their infamous Cidra Scandal? (also covered brilliantly by Fierce Pharma)
“..The woman who raised the red flag on GlaxoSmithKline’s ($GSK) troubled Cidra, Puerto Rico, plant has now spoken to 60 Minutes. Cheryl Eckard, whose whistleblower suit yielded last year’s $750 million settlement and a guilty plea for one of GSK’s subsidiaries, gave the news program a behind-the-scenes look at the problems she observed at the plant and the company’s reaction to her criticism.
Eckard was a quality control inspector for the company when she found trouble at Cidra in 2002. According to the CBS News coverage, Eckard found a host of mess-ups there. “All the systems were broken, the facility was broken, the equipment was broken, the processes were broken.
It was the worst thing I had run across in my career,” she told 60 Minutes. Tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles, she now says…”
And the other scandals over the years, listed here, from Fierce Pharma-
“…It has been a difficult couple of years for GlaxoSmithKline, with extensive recalls in the U.S. In April, the company recalled 1.7 million doses of its quadrivalent flu vaccine that were manufactured at a plant in Canada that ran into a series of manufacturing issues last year including an FDA warning letter.
Last month, the drugmaker had to recall nearly 4 million tubes of toothpaste that might have been contaminated with wood particles. But in that case, the product was not manufactured by GSK itself but by Oratech, a Utah-based contractor.
Last year the drugmaker recalled Paxil patches after being lambasted by the FDA in a warning letter for releasing potentially contaminated products from a plant in Ireland and not even bothering to tell customers about the potential for problems...”
Despite GSK’s recall last year, Fierce Pharma reports this month that GSK didn’t even bother to clean up it’s act – and this has led to sterner warnings, again from the FDA :
The letter, posted Tuesday by the FDA, dates back to an inspection conducted a year ago in July 2015 which led the drugmaker to stop production in part of the plant in Worthing. The FDA said it uncovered 187 instances of penicillin in nonpenicillin manufacturing areas in 3 1/2 years, and that GSK has still not updated its cleaning validation plan.
“Contamination of non-beta-lactam drugs with beta-lactam drugs presents great risks to patient safety, including anaphylaxis and death. No safe level of penicillin contamination has been determined to be a tolerable risk,” the FDA warning letter points out.
In 2015, GSK recalled nearly 130,000 Ventolin inhalers because apparently they didn’t have the right dosage.
“…The GSK Ventolin inhalers were produced at its plant in Zebulon, NC. That is the facility that GlaxoSmithKline had to close for about a week last summer to clean cooling towers for the facility after testing turned up the bacteria for Legionnaires’ disease. The plant was idled briefly since cooling was essential to production, but GSK assured the public that products were unaffected by the discovery…”
Back in April 2015, a GSK Whistle-blower working in a GSK manufacturing plant (Stiefel in Sligo) in Ireland contacted me about possible asbestos contamination there, which – according to the whistle-blower – was affecting staff health as well as possibly contaminating GSK products made there…
see here :
“…Last year I received an e-mail from a whistle-blower based at the GSK (Stiefel) site who claimed that there was a major contamination problem at this GSK site in Sligo in Ireland. Allegedly, there was asbestos contamination which affected a few GSK drugs that are manufactured there (and also according to these claims- if they are true- some employees health has been affected by these health and safety breeches). I cannot verify with certainty if any of this is true or factual, as it seems the whistle-blower got cold feet and didn’t follow up after a few emails- (for one reason or other maybe they got scared, which is understandable considering GSK’s reputation). However, I happened to stumble upon this strange (locked) blog which is called gsksligo.blogspot.uk, and a number of posts on Google plus (screen-shots below) which seem to be from a Whistle-blower involved in somehow attempting to alert the public to the alleged various issues (contamination etc) at the GSK Stiefel Site in Sligo, Ireland…”
This whistle-blower didn’t contact further than a few e-mails at the time, and it seem that this scandal has been hushed up…
In light of all this, I have to wonder, how much of GSK’s dodgy manufacturing processes gets hushed up regularly, or how much information on contamination etc is suppressed?
It seems that the FDA is useless when it comes to protecting the public, even when they have caught GSK, they aren’t tough enough with their follow up.
If what we do find out about (such as the Cidra scandal etc) is appalling – think about the stuff that goes on which the public never find out about…
How many contaminated GSK products harm oblivious consumers, and patients, on a daily, and yearly basis? And how much gets reported? or how much of this contaminated stuff goes by unnoticed in the pharmacies and the doctors surgeries. How many people get ill, damaged, or harmed, from contaminated GSK products without even knowing it?
And most importantly…
How many die?..