FDA: Particles of Trash in Genzyme Drugs

Bits of Steel, Rubber and Fiber Found in Medicine Used to Treat Enzyme Disorders

(AP)  Federal health regulators have found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues.

The Food and Drug Administration said Friday that bits of steel, rubber and fiber found in vials of drugs used to treat rare enzyme disorders could cause serious adverse health effects for patients.

Despite those problems, the FDA said the products would remain on the market, because there are few alternative treatments.

FDA regulators say doctors should closely inspect vials for particles before injecting them into patients. Doctors should return the product to Genzyme if they suspect contamination, the agency said. Physicians should also watch for potential allergic reactions, blood clots and other problems in patients.

Shares of Genzyme Corp. dropped $4.17, or 7.8 percent, to $49 in afternoon trading.

The FDA announcement is the second case of contamination for the Cambridge, Mass.-based company this year. In June, Genzyme was forced to shut down a key production facility due to viral contamination.

Genzyme did not return repeated calls for comment Friday.

The drugs affected by the latest announcement include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen. All are manufactured at a biotech plant in Allston Landing, Mass., where FDA regulators are conducting an inspection.

The FDA estimates the contamination only affects about 1 percent of Genzyme's products, and no adverse events have been reported to the government.

The agency said it supports Genzyme's decision to leave the products on the market because the health risks are minor and there are few alternative treatments.

“We have worked continuously with Genzyme to ensure the continued availability of safe and effective products to meet the medical needs of patients with rare medical disorders,” said Dr. Jason Woo, FDA's associate director of medical affairs.

Genzyme specializes in biotech drugs to treat rare diseases.

The company's best-selling drug Cerezyme treats Gaucher disease, an enzyme disorder that can result in liver and neurological problems. Its second-best seller Fabrazyme treats an inherited disorder known as Fabry disease, which is caused by the buildup of a particular type of fat in the body's cells.

The two drugs had combined sales of roughly $1.7 billion last year.

[medicconcerns]

This company is a monopoly right now and is taking advantage of their unique position in the marketplace. Since they know there are no alternatives approved and companies are only now going through trials they know that the government can't afford to risk people lives by stopping the production.

I believe an alternative to simply washing down the bioreactors is to place a filter on the hose which is flushing the system so no additional contaminants can go into the production bioreactors.

Someone within the quality assurance section and company should be held accountable and adminstrative steps should be taken since this is the second time we are aware of that a problem has surfaced.

In addition if a small particle gets in the artery, since this is an infusion who knows what can happen.

[PoisonedPup]

Lightning does strike twice in the same place. At least it did in my life. I now have heavy metal poisoning once again. The drug I took that made me so sick was made by Caraco Pharmaceutical Laboratories Ltd., a drug manufacturing company (in/near Detroit)that was shut down by the FDA this year for sloppy manufacturing practices where this drug company had tainted ingredients that came from their parent company in India (Sun Pharmaceutical). The Titanium Dioxide (approved by the FDA)in the drug I took, has a cocktail of heavy metals in it. Titanium Dioxide is in most all our pharmaceuticals (Rx & Over the counter), most of our processed foods and in our sun screen we rub all over our children's bodies. These products do come from China and directly into our American food chain. Email me and I will send you documentation: [e-mail]. The FDA knew that Caraco had gross manufacturing quality control issues as far back as 2000 and it took them until 2009 to shut them down. Check out the warning letters on the FDA website. I personally have friends who were hurt and killed by these Caraco drugs. The Caraco drug my husband took may have had metal fillings in it. The Veteran's Adminsitration health system had contracts with Caraco. My husband took Caraco drugs through the VA. I am alleging FDA negligence with very good personal experience to back me up. PoisonedPup

[the0racle]

Who needs 'death panels' when we have the FDA and Big Pharma?

[MalloryDavis]

Bottom line: The two drugs had combined sales of roughly $1.7 billion last year.

Yea, these guys FDA are looking out for us. IT's BS folks!

[rwsmith29456]

I think the best solution for everybody, even Genzyme, would be for Genzyme to FIX IT themselves RIGHT NOW. Medicines are far too critical to allow lax quality control. If they do that themselves maybe we won't be compared to those who knowingly contaminate products.

[galbraith45]

FDA IS WRONG THIS PRODUCT HAS AND WILL KILL

[band3x]

yup

[dontknowitall]

If this were manufactured in China there would be an uproar. Profits and satisfying the share holders. It's all about the cash and nothing but the cash. So help me Ben Franklin.

[stn_sage]

Despite those problems, the FDA said the products would remain on the market, because there are few alternative treatments.

FDA regulators say doctors should closely inspect vials for particles before injecting them into patients. Doctors should return the product to Genzyme if they suspect contamination, the agency said. Physicians should also watch for potential allergic reactions, blood clots and other problems in patients. (from the article)
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I'd point out the following:

1. If a product is killing or maiming peoples, it should be PULLED immediately. That, there is no drug company produced alternative, is irrelevant! There may be homeopathic treatments available!

2. It is TOTALLY unacceptable and irresponsible of the FDA to expect doctors to have to spend their limited time...having to also be a quality control technician! THIS, IS the responsibility of the companies making these drugs...NOT the doctors administering them!

3. The previous two points lead me to conclude that the FDA is a totally dysfunctional, inefficient, ethically bankrupt-run organization that needs a serious audit, replacement of leadership, and review of mission objectives and priorities!

In short, the FDA appears to be responsible for the deaths of a multitude of Americans each year through their dangerous and irresponsible policies! This MUST stop!

[Phxfire]

It seems that this company is taking advantage of their unique position to thumb their noses at regulations and basic housekeeping. They know that the government can't afford to risk people lives even more by stopping the production so they just get lazy. 1.7 billion? Sounds like a HUGE fine is in order.

[Xamkr]

Too true.

It wouldn't be surprising if the cause turned out to be something simple like an old hose or a cheap valve.