The FDA again adds more drugs to recall list
CNN – The US Food and Drug Administration again added to its list of products that are included in the recall of drugs containing valsartan, a generic ingredient that helps people with high blood pressure and heart failure.
That ingredient in the recalled drugs was tainted with a possible carcinogen.
The FDA testing of these products determined that an additional lot of brands sold under the name RemedyRepack needed to be added to the recall list.
Several pills that contain valsartan have been under a voluntary recall since July.
The drugs were tainted with NDMA, an impurity that is considered a possible carcinogen by the US Environmental Protection Agency.
It’s an organic chemical used to make liquid rocket fuel and a byproduct from manufacturing some pesticides and processing fish.
NDMA can be unintentionally introduced into manufacturing through certain chemical reactions.
Not all versions of the drugs have been recalled, but the FDA keeps a regularly updated list of the drugs that have been impacted.
The agency began testing valsartan products for the substance NDMA after it learned that Zhejiang Huahai Pharmaceuticals found it in several batches of its medications.
The FDA also began testing for another impurity, N-Nitrosodiethylamine, or NDEA, after it was identified in three lots of the drugs made by Torrent Pharmaceuticals. NDEA is also a suspected human carcinogen. Not all batches of these medications have been found to be contaminated.
The FDA placed Zhejiang Huahai Pharmaceuticals on an import alert at the end of September, meaning all active pharmaceutical products and finished products made by the company will not be permitted to enter the US. The FDA made that decision after its recent inspection of the facility. Read more.
Fake drugs: The global industry putting your life at risk
CNN – This is a story of how the manufacture and distribution of medicines today is such a complex, globalized affair that it is often hard to track where fake or substandard medicines come from and where they go.
These medicines could make you ill or even kill you, even if you don’t take them.
Substandards and fakes
The term “poor-quality medicines” is something of a catch-all. It includes “substandards”, medicines that have had inadequate quality control or that have degraded from improper storage or the passage of time.
And it includes falsified medicines – fakes – that claim to be what they are not. These may not be made by the manufacturer whose name is on the package, and they may not contain the stated ingredients in the stated quantities.
Poor-quality medicines might not work. Like those peddled by Peter Gillespie, who was jailed for introducing 72,000 packets of falsified medicines into the UK’s distribution system from 2006 to 2007. 25,000 packets reached pharmacies and were given to patients.
These knock-off tablets were used to treat heart disease, pancreatic cancer, and mental illnesses, and had none or only part of the active ingredient they were supposed to contain. This meant that those people’s illnesses were left to take their course.
Poor-quality medicines can kill you if you take them. As happened with Thomas Rybinski, a 56-year-old autoworker from Tennessee, who got an injection for his back pain in 2012. He fell ill and died because the medicine had contaminants that caused fungal meningitis.
The batch of medicine, originating in a New England pharmacy with close to no quality control, ended up causing severe infections in nearly 800 people across the USA, killing 64 of them.
Poor-quality medicines can kill you even if you don’t take them. Antimicrobial drugs (including antibiotics and antivirals) that have too little active ingredient are generally accepted to help disease-causing bugs evolve so that they develop resistance to treatment even with good-quality antimicrobials. And then these bugs spread.
With some drugs, like statins or arthritis drugs, the effects of poor quality are confined to those taking them.
But with antimicrobials, inappropriate use reduces their effectiveness for everyone else. Read more.