Contaminated drug lawyers at Pintas & Mullins Law Firm recently reported of a second fungal contamination at a compounding center, Med Prep, which was the second contamination report after the deadly fungal meningitis outbreak six months ago. Unfortunately, yet another compounding pharmacy recently recalled its Avastin medications after one man died and dozens of others were sickened from the drug.
The recall, initiated by Clinical Specialties, located in Georgia, came three days after Med prep suspended its operations when visible particles of mold were found in its IV medications. Both safety alerts were announced only six months after the fatal outbreak of fungal meningitis that injured over 700 patients and killed 50.
These contaminations are rightfully causing great public concern, as healthcare officials and patients throughout the country are asking the FDA and state departments to establish clearer authority over compounding pharmacies. Although the FDA has increased compounding inspections in recent months, the oversight and licensing of these pharmacies is largely left to state departments of public health.
For example, Framingham, where the New England Compounding Pharmacy (NECC) is located, is only about a 30 minute from downtown Boston, from where the Massachusetts Department of Public Health operates. This agency is responsible for NECC’s licensing, oversight, and supervision of its operations.
After the initial reports of the fungal meningitis caused by NECC’S medications, FDA inspectors immediately infiltrated the compounding pharmacy. Federal inspectors found mold and bacteria growing in the building, observing green and yellow residue on the hoods of the equipment used to mix medicines. A boiler, located 30 feet from the entrance to the prep room, was found leaking, with no evidence of attempts to clean it. Inspectors also said that NECC failed to maintain continuous airflow and filtering throughout the building.
The question most are asking now is how the sterility problems, which were so evident here, continue to persist in compounding pharmacies across the country. This latest recall was initiated after five initial reports were released of patients suffering eye infections from the Clinical Specialties products. Avastin is a cancer drug for IV use, and Clinical Specialties mixed the drug into smaller doses for patients to use as eye injections, to treat a condition called wet macular degeneration.
Avastin is very similar to the much more expensive (nearly $2,000 more per lot) Lucentis, which is the approved drug for the eye condition. Clinical Specialties repackaged Avastin into single-dose syringes and shipped them to health care facilities in Indiana, Georgia, Louisiana, and South Carolina.
A man from Inglewood, Louisiana died in the summer of 2012 after receiving an Avastin injection that was contaminated with bacteria. The infection started in his eye and spread to his brain. Four other patients in the same hospital suffered eye infections from the tainted drug.
Dozens of other eye infections have been reported in California, Florida,
and Tennessee over the past few years due to contaminated Avastin medications
from compounding pharmacies. One man in Ohio was rendered permanently
blind after receiving a tainted eye injection made at a local compounding
pharmacy. His family requested the Ohio Board of Pharmacy investigate
into the matter, although no conclusions have yet been released.
The investigation into Med Prep is also currently evolving, as is that into the New England Compounding Center. The latter faces dozens of lawsuits from the fungal meningitis outbreak, and recently filed for bankruptcy protection. Compounding pharmacies like these operate to mix specialized medications – unapproved by the FDA – for individual patients. Many are saying these contaminations were a catastrophe waiting to happen because of the extreme lack of oversight into these facilities.
Dangerous drug lawyers at Pintas & Mullins Law Firm will continue to shed light on the stories surrounding compounding pharmacies and the risks associated with their drugs. If you or someone you love was seriously injured by a contaminated or defective medication, you may be entitled to compensation through a compounding pharmacy lawsuit.