FDA Discovers Pieces of Steel and Rubber in Genzyme Drugs
Federal health regulators have found tiny particles of trash in drugs made by Genzyme, a biotechnology company. This is the second time this year the company has been cited for contamination issues. According to an Associated Press article, on November 13, the Food and Drug Administration said 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.
The FDA said the products would remain on the market because there are few alternative treatments. They also said doctors should closely inspect vials for particles before injecting them into patients. Doctors should return the defective pharmaceutical to Genzyme if they suspect contamination and watch for potential allergic reactions, blood clots and other problems in patients.
In June, Genzyme was forced to shut down a key production facility due to viral contamination.
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.
Genzyme specializes in biotech drugs to treat rare diseases.
The company’s drug Cerezyme treats Gaucher disease, an enzyme disorder that can result in liver and neurological problems. Another drug, 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.
People of all ages take prescription drugs, non- prescription drugs, and supplements on daily basis in the United States to prevent and treat various illnesses. Although these medications are supposed to help people, many people have suffered serious side effects, and even death.
If a manufacturer produces drugs or supplements that are defective, they can and should be held responsible for the injuries they cause. As a manufacturer of pharmaceuticals, the company has an obligation to make a safe product, which includes various aspects such as thoroughly inspecting the product and affixing an appropriate label on the packaging.
It is extremely important that you hire a skilled PA drug injury attorney to prove that the manufacturer was responsible for producing a defective product, as this is a very complicated and difficult part of the case. It is essential to have representation on your side that has extensive experience representing people in similar matters. If you or a loved one has been injured as the result of a dangerous drug reaction in Pennsylvania, contact Cherry Fieger and Marciano, today for a free consultation.
Source article: http://www.philly.com/philly/wires/ap/business/20091113_ap_fdafindsbitsofsteelrubberingenzymedrugs.html
