News Review From Harvard Medical School -- Pharmacy Probe Expands; Deaths Rise to 20
U.S. drug regulators have expanded their investigation of a pharmacy linked to an outbreak of meningitis. The New England Compounding Center of Framingham, Mass., has been shut down since last month. At least 250 cases of meningitis caused by a fungus have been linked to steroid shots made at the pharmacy. Most of them were linked to a fungus called Exserohilum rostratum. The infections have caused at least 20 deaths. The Food and Drug Administration (FDA) confirmed October 18 that this fungus was found in one lot of steroid vials made by the company. The FDA also said it is looking into the cause of infections among 3 people who received other kinds of drugs made by New England Compounding. The fungus involved in the steroid injections is commonly found in nature. FDA still is looking into how it could have contaminated the drugs used to produce the steroid shots. The Associated Press wrote about the case.
By Howard LeWine, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
Based on what we already knew, the recent outbreak of fungal meningitis had to be caused by contamination of products from the New England Compounding Center. Yesterday, the U.S. Centers for Disease Control and Prevention confirmed that at least one lot of steroid shots contained the same type of fungus blamed for dozens of cases.
The fungus is Exserohilum rostrate. It has never previously been reported to cause meningitis. The very few cases of human infection with this fungus have been primarily in people with impaired immune systems.
Exserohilum rostrate is not some dangerous, bizarre germ. Like many fungi, it lives all around us. It's in grass, soil and decaying plant products. It especially thrives in warm and humid climates. You have almost surely been exposed to it during your life.
Naturally, many people have become wary of all injections. But this is a very unusual situation. Millions of injections are safely given to people every week. There always is a tiny risk of introducing infection whenever you pierce the skin. These rare infections are almost always caused by the needle carrying skin bacteria below the skin surface. They are almost never caused by contaminated drugs.
So what happened this time? Why are there more than 250 fungal meningitis cases related to contaminated steroid injections?
How the original contamination occurred at the facility is still under investigation. But a little background might offer some insight as to what happened.
Compounding is the way that a pharmacist can prepare a medicine that is not mass-manufactured. For example, a doctor writes a prescription for a patient who needs a particular mixture of drugs. This special mixture is not made by any drug company. The pharmacist opens the sterile vials of each drug and mixes them together in the proportions the doctor orders.
The pharmacist uses techniques to avoid contamination. But once the vials are open, contamination is always possible.
For medicines taken by mouth or applied to the skin, any contamination is highly unlikely to cause a problem. Stomach acid, the intestinal lining and the skin act as natural barriers. But if a drug is injected, it bypasses these protections. . An injection can introduce germs directly into the body.
When compounding of an injectable drug is done for a single patient, only one person faces a potential risk of contamination. But in this case, the New England Compounding Center mass-produced the compounded product for steroid spinal injections. So contamination of one lot affected a large number of people.
What Changes Can I Make Now?
Most people who received a product from the New England Compounding Center in the last few months have been contacted. If you have recently had a spinal steroid injection, even if it was compounded at this facility, you are unlikely to develop meningitis if you have had no symptoms by now. However, if you develop symptoms, seek medical care right away.
People with meningitis almost always have a severe headache and stiff neck. They usually have fever and body aches. They avoid bright lights. They may have difficulty concentrating and later can become confused.
If you have possible meningitis symptoms, call your doctor right away or go to an urgent care center for evaluation.
Today, viruses are the most common cause of meningitis in the United States. In general, the outlook is excellent. No antibiotics are needed.
Bacterial meningitis, what people used to call spinal meningitis, has declined dramatically. Vaccines are available to protect you against the three most common types of bacteria that caused meningitis in the past.
Be sure you and your children have been fully vaccinated against:
- Streptococcus pneumoniae, the cause of pneumococcal meningitis
- Hemophilus influenza, the cause of H. flu meningitis
- Neisseria meningitides, the cause of meningococcal meningitis
Fungal meningitis is much less common. It occurs most often in people with very impaired immune systems.
What Can I Expect Looking to the Future?
This case should not stop you from getting injections that you need. Injected medicines made by drug companies are extremely safe. You can expect guidelines regarding compounded injected medicines to be reviewed.