Heparin Deaths Reveal Troubles with FDA, Supply Chain

Four recent deaths and numerous serious reactions have caused Baxter Healthcare to temporarily cease manufacture of their multiple-dose vials of the injectable blood-thinning drug heparin.  While it isn’t clear if the four deaths can be directly linked to Baxter’s heparin, in the last few months the FDA has received over 350 reports of adverse reactions to heparin, and 40% of those reports were considered serious.  These reports have triggered further investigation into Baxter’s manufacturing and quality control processes, and have highlighted some troubling facts about how medications are made, not to mention more worries about the lack of appropriate FDA oversight of the process.

 

The majority of the serious side effects took place at kidney dialysis centers, where heparin is used to prevent a patient’s blood from clotting during dialysis.  Side effects include difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock.  The adverse effects have been traced to the Chinese batches of Baxter’s drug, and nine specific lots of heparin were recalled.  What is chilling is that the FDA actually thought it had inspected Baxter’s Chinese heparin supplier, however it turns out that they inspected another plant with a similar name instead.  The irony is that these mistakes and revelations are coming at a time when the FDA is warning consumers to avoid purchasing drugs from other countries, as they lack the promise of purity and safety provided by FDA oversight.

 

This is one of the impacts of our increasingly global economy.  In a never ending quest for cheaper drugs, manufacturers are looking to China and other less-expensive (and less-regulated) countries for the raw ingredients and precursors that are eventually made into the drugs and medications sold in the United States.  Given the already shaky hold the FDA has on the mega-powerful pharmaceutical industry, it isn’t any surprise that they have not been able to keep track of the tangled supply chains and ever-changing manufacturers in far-flung countries.

 

No Traceability, Little Oversight

 

Heparin is one of the oldest drugs still in use in the United States, and today is made primarily from pig intestines.  The convoluted process for making heparin involves many steps and hand-offs, which means that when problems arise it can be next to impossible to trace back to what went wrong and where.  Part of the problem is that the raw ingredients for heparin come from small suppliers in China that are often registered as chemical makers and not drug producers, so they avoid having to answer to Chinese drug regulators and the FDA.  In fact, not only do drug makers not always know where their raw ingredients came from, but factories extracting ingredients from pig tissue don’t always know where their products end up.  Right now there is simply no way to trace from the source to the end product, or from the end product back to the source.  This makes investigating the recent deaths and adverse reactions a challenge for regulators, and a grave concern for patients and medical professionals.

 

It takes about 3,000 pigs to make one kilogram of heparin, and when you consider that more than a million doses of heparin are sold in the Unites States alone each month the scope of the challenge becomes apparent.  Not only is does China produce an enormous amount of the drugs that end up in America, but these drugs are produced in many, many places.  The GAO estimates that there are over 700 factories in China that produce ingredients used in American pharmaceuticals, and it is unknown how many of these factories produce the raw ingredients for heparin.  However, just because linking the source pigs to the final product would be very difficult does not mean that it should not be done.

 

Unfortunately, the FDA’s current stance on the use of animal tissue as a precursor to drugs is that purification steps in the drug making process are sufficient to produce a pure end product, and that pharmaceutical companies are responsible for appropriately sourcing and processing the raw material.  As this pretty much amounts to self-regulation, we have to ask if that is adequate quality control from an industry that has given us the Fen-Phen and Vioxx debacles.  If the purification steps are really adequate to ensure a drug’s safety, why did manufacturers stop using cow tissue after the discovery of bovine spongiform encephalopathy (“mad cow” disease)?  If concerns about mad cow were real enough to cause drug makers to switch from cow to pig tissue for extracting heparin’s raw ingredients, why aren’t additional safeguards necessary to ensure that the current process follows adequate quality control steps?

 

Immediate Action

 

According to a press release from the FDA, physicians, dialysis center staff and health care providers are advised to use an alternate source of heparin or another blood-thinning drug when possible. When only Baxter product is available:

• Administer the heparin as an infusion (not a bolus) whenever possible.
• Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired clinical effect.
• Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity and ensure that resuscitation equipment is available.
• Consider pretreatment with corticosteroids (cortisone type medicines) or antihistamines (drugs that relieve the symptoms of allergic reactions) although it is not known if such pretreatment is effective.

 

If medical professionals or patients note any adverse reactions to heparin, they should be reported immediately to FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

 

If you believe that you or somebody you love have been unfortunate enough to become the victim of medical malpractice, then Richard Serpe wants to help you.  The Serpe Firm is a Virginia based practice serving the Norfolk, Tidewater, Virginia Beach, and Richmond areas.  Contact us today and let us help you recover from the devastating effects of a medical mistake and get you the compensation you deserve.

 

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