Heparin Manufacturing Change Leaves Mother Frustrated

Detroit, MICathy is angry: immediately after her disabled daughter was given heparin for a blood clot in her lung, she suffered a heparin allergic reaction. "My daughter's abdomen was swelling and the pump in her side (she has pulmonary hypertension) started to bleed outward," says Cathy. "The doctor stopped the heparin but she needed two units of blood."

The doctors told Cathy there was nothing more they could do and she would better off at home, but three weeks later she had to go back to hospital. "My daughter also has lupus," explains Cathy. "I told them about her reaction to heparin and that she couldn't have it again. But a few days later she had the same symptoms:her body was swollen and she was losing more blood--Ohmigod, I thought we decided no more heparin!

'We have been giving her heparin shots,' the nurse said.
'What is the difference? Isn't heparin heparin?' I asked, furiously.
'No, there is a difference between injections and IV,' she replied.
'I'm not understanding that, I specifically said NO HEPARIN. I don't know why my daughter is so sick.'

Her body finally shut down. She was sent to ICU and they said she wasn't going to make it. Again I told the doctors that she couldn't have any more heparin, so they gave her Coumadin instead. About three days later, she gradually started to get better.

She was transferred to a nursing home a few weeks later and she is still there. I visit her every day, give her a bath and feed her—I spend about 3 hours in the morning before work and another 3 hours after work. I'm hopeful that she will come home soon…

I went online and googled heparin; I wanted to know if there were any side effects or if it was just my imagination. No one at the hospital would talk to me about it; I am so frustrated and these doctors make me look like I'm crazy."

Cathy is even more frustrated now that the FDA announced a manufacturing change to the anti-clotting drug heparin that will likely decrease its potency. Did Cathy's daughter receive too much heparin? According to HealthDay News (October 1, 2009) the revised reference standard and unit definition for heparin is about 10 percent less potent than the former version and will come into effect October 1, 2009 for production, but the agency has asked that they not ship this new product to customers until Oct. 8, 2009, or later, reasoning that the delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices.
Health Day News also said manufacturers of heparin have already started making units under the new guidelines, which will make it easier to spot impurities.

FDA said that "Adjustments may be needed to achieve desired anticoagulant effect in some patients". Was Cathy's daughter one of "some patients"? Did she receive contaminated heparin? Cathy doesn't know if she will ever find out, but is hopeful that a lawyer will be able to pull all her daughter's medical records…