Ongoing Investigations Reveals New Infected Drugs
As we mentioned in our previous Blog entry, on or before May 21, 2012* the New England Compounding Center (NECC) released the drug Methylprednisolone Acetate (80 mg/ml) that was contaminated with a fungus. This drug is frequently used in pain management procedures that involve injections around the spinal cord. It is also used to inject painful joints. This contaminated drug has resulted in an outbreak of fungal meningitis and fungal joint infections. As of yesterday, November 1, the outbreak has grown. The number of states with cases had grown from 16 to 19, the number of cases from 304 to 386 and the number of deaths from 23 to 28.
The CDC and FDA announced yesterday that contamination has been identified in additional medical products from New England Compounding Center. Testing revealed contamination by bacteria (Bacillus species) in vials of the drug Betamethasone and in Cardioplegia Solution that were distributed and later recalled by NECC on October 6, 2012. Betamethasone is a corticosteroid used as a topical cream to relieve skin irritation in patients with eczema and psoriasis. An oral and injectable form is also produced. Betamethasone is also administered to mothers to stimulate fetal lung maturation. It is the injectable form that was found to be contaminated.
Cardioplegia Solution is used during open heart surgery. While the patient is on cardiopulmonary bypass this high potassium containing solution is injected into the coronary arteries stopping the heart to facilitate the surgery. Once the bypasses are complete the solution is allowed to wash out and cardiac function is restored. These bacteria are commonly found in the environment and are rarely reported as pathogenic. When found in patient samples, this bacterium is usually thought to be a skin contaminant. Different conclusions should be drawn in patients with positive cultures if they have received any of the recalled medications.
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Additional microbial organisms may be identified in recalled NECC products as additional laboratory testing is completed.
Ameridose – Another Pharmaceutical Company Releasing Infected Drugs
(Photo by Cj Gunther/European Pressphoto Agency)
Ameridose is the latest company to withdraw drugs from the market over concerns about their quality.
In the midst of all this the drug company Ameridose has issued a Voluntary Recall of all its medical products. Ameridose is based in Westborough, MA and is managed by some of the same people as NECC. The FDA and CDC are not aware of any infections associated with products from Ameridose. However, preliminary results of the FDA investigation of Ameridose have raised concerns about a possible lack of sterility of products produced and distributed by Ameridose. Since there are no infections associated with Ameridose products the FDA and CDC are not recommending that healthcare providers contact patients who have received Ameridose products. However, continued vigilance for infections in patients with complaints should be kept. The FDA is recommending the healthcare providers isolate Ameridose products for return.
The FDA maintains a Critical Drug Shortage List and some of the Ameridose products that are being recalled are on this list.
If you or a family member has been infected with a fungus from an epidural or intra-articular injection you should consult an attorney to know your rights. The attorneys at Michles & Booth are ready to help you or your family. Please call (850) 438-4848 or toll free at (800) 436-3606, or contact us directly at our website.