Monday, September 30, 2019

Are generics safe? Zantac the latest problem

BBC reports on Zantac/Ranitidine recall.

article is lousy: Gives no reason and points no fingers, nor does it say if it is only generics or the brand name.

Bloomberg says it is made in China and India.

In the meantime, the Italian Drug Agency said last week it was ordering a recall of all versions of Zantac made with active ingredient from Saraca, the Indian manufacturer. Italian regulators also banned the use of some types of Zantac produced by other pharmaceutical companies pending analysis of the drugs.


Bloomberg has an article on the problem of generics.

this photo pretty well says it all:


the article discusses the contamination of Valsartan and other ACE2 inhibitor type BP meds.


Companies conduct clinical trials in humans over several years to prove a drug is safe and effective. But 90% of all medications prescribed to Americans are generics. They’re cheaper, they’re supposed to work the same way, and they receive less scrutiny right from the start. Companies manufacturing generic drugs have to show only that patients will absorb them at the same rate as the name-brand medications they mimic.At least 80% of the active pharmaceutical ingredients, or APIs, for all drugs are made in Chinese and Indian factories that U.S. pharmaceutical companies never have to identify to patients, using raw materials whose sources the pharmaceutical companies don’t know much about.The FDA checks less than 1% of drugs for impurities or potency before letting them into the country. Surveillance inspections of overseas factories have declined since 2016, even as the agency is under pressure to get more generics to market more quickly.
the article goes into a lot more detail about the Valsartan contamination and about China's growing pharmacy manufacturing business, but the clue is that the company switched to a different solvent, which was cheaper. Then other companies read the patent application and figured they too could make the drug cheaper and voila, many sources of the BP medicine also produced contaminated medicine.

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