Amoxycilin, Aciclovir and Heparin – Safe or not?

I picked up some Aciclovir from the local pharmacy today. Aciclovir is one of the three drugs made by Ranbaxy from India. Ranbaxy made headlines after it failed the USFDA's (US Food and Drug Administration) audit process. Should I give the Aciclovir to Princess of the House? I am not sure, so I rang my local pharmacy. The pharmacist I spoke to says there is no evidence to suggest Ranbaxy products in NZ are problematic.

Ministry Chief Advisor Public Health Dr Ashley Bloomfield says "there is no evidence that individual drugs have been affected and patients are advised they should continue taking them." To be really cynical - how does Dr Bloomfield know? Can he trace the origin and the compounds used by Ranbaxy and can be sure it is not sourced from China? Can he assure us there is no contamination in Aciclovir or the Amoxycilin?

I find it distressing Dr Bloomfield can be so certain when the audit process done by the US has failed the company. What can we do??? Is your child ill? Is your child being given Amoxycilin (an antibiotic) or Aciclovir (to treat cold sores)? Princess of the House’s best mate the one with Rapuzel-hair, slept here last night. She has had 2 doses of Amoxycilin since yesterday evening. Should her mom be worried too?

The US FDA has banned about 30 drugs made by Ranbaxy including Cipro (which Princess of the House is also on!) and cholesterol pill Zocor – citing poor quality at two of Ranbaxy’s factories. According to the Financial Times, “Ranbaxy’s latest troubles come only two months after the US Justice Department intensified legal action against the company, alleging adulteration of some of its products. The company has insisted the claims are “baseless”.

The USFDA last week criticised Ranbaxy for violations to ”good manufacturing practice”. It said it could not be sure that processing took place in sterile conditions, nor that there was protection against cross-contamination of pharmaceuticals

What should we do? My local pharmacist tells me there are other sources of Aciclovir (Pacific Pharmaceuticals), but that is not funded by Pharmac. I checked the box on our Cipro – it says “Marketed by Pacific Pharmaceuticals”. Good, do I feel safer?

Am I being paranoid now? Shouldn’t I be? What if Ranbaxy’s Amoxycilin is indeed substandard. Will NZ be scrambling (like the rest of the world will be) for fresh supplies? According to the Ministry of Health’s web info, about 400,000 Amoxycilin prescriptions are made a year; and a 160,000 prescriptions for Aciclovir.

I think I am going to be more paranoid than ever. Pretzel who commented on my blog led me to a site which lists stories of counterfeit products made by China. I felt sick in the stomach when I saw heparin on the list of counterfeits that have shown up in the world. Princess of the House was in hospital for 8 weeks and had many doses of heparin injected into her body. Heparin helps thin the blood to prevent clots.

Heparin is made from the intestines of slaughtered pigs. The mucous membrane from the intestines is collected and cooked, eventually producing a dry substance known as crude heparin.

Baxter suspended the production of heparin in multi-dose vials after four patients died in the US after high doses of heparin. There were also 350 reports of severe allergic reactions to heparin, with symptoms including a rapid drop in blood pressure, burning sensations, headaches, throat swelling and a shortness of breath.

According to the website (check it out yourself Business Action to Stop Counterfeiting and Piracy (BASCAP) contaminated heparin has been linked to 19 deaths in the US and hundreds of allergic reactions. The gist I got from reading the site was that Baxter, which has been buying active ingredients to make heparin, was being sold counterfeit by cowboy operators in China.

Baxter bought its heparin ingredient from China’s Changzhou SPL, a factory in the city of the same name. This facility is actually 55 per cent owned by Scientific Protein Laboratories (does this sound familiar - Sanlu and Fonterra??) which has another manufacturing site in Wisconsin, US. All this happened in April.

The US, Germany, France, Italy, Denmark, Switzerland and Japan have been reported to have pulled heparin products from the market due to the presence of contamination or as a precautionary measure after API links to China were made.

When I did more reading, I found that Australia's Therapeutic Goods Administration (TGA) too had discovered contamination in samples of heparin distributed by UK-based drug giant AstraZeneca. Other manufacturers of heparin are: Hospira and Pfizer. Australia’s drug watchdog TGA says: “AstraZeneca has since confirmed that its heparin API was sourced form China and it is in discussions with the TGA to recall the affected product as soon as possible. The firm also indicated that it is now evaluating its China supply chain.”

I checked NZ’s Ministry of Health’s website and found this statement: “So far, testing of the finished products being supplied to patients in New Zealand indicates that these products are free from contamination.” Should I rest assured? Are we relying on our own testing mechanisms or USFDA to do our job? Do we trust the drug maker’s supply chain?

What everyone should be asking of the Ministry of Health is:
 How many drugs do we import from NZ that have compounds made in China or India or Thailand or Cambodia etc?
 How do we know these compounds are safe for users in NZ?
 Is Pharmac’s funding warped in anyway? (If I don’t buy Ranbaxy’s Aciclovir, who else can I buy from??)
 Should NZ rely on the USFDA to do primary regulation/tests for us?

This is just the tip of the iceberg. Our logic must be, for now, to have some control over NZ’s own supply chain. We know we can’t trust big MNCs -- be they hotshot financial companies (like Merrill or Goldman or AIG) or big pharmas like Baxter or Astra Zeneca who do get duped by unethical Chinese merchants. I have stopped buying Made-in-China food. But the question is can I stop buying drugs with Chinese ingredients or ingredients from unknown sources.