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Table of Contents

Preface

Introductory Comments

General Questions About FOP

Genetics of FOP

How FOP Affects the Body

Care and Treatment

Activities

Feelings About FOP

Helpful Addresses

Family Resources

Ideas for Independence

Medical Articles

Acknowledgments and Contributions

Immunizations in Children with FOP: Do's, Don'ts, and Dilemmas

Frederick S. Kaplan, M.D.

Many have observed that "routine" immunizations may provoke new episodes of heterotopic ossification in patients with FOP. This observation has provoked great concern within the FOP community and raises the question: Should children with FOP receive routine childhood immunizations?

In general, injections into a muscle should be avoided in patients with FOP. Although intramuscular injections do not always provoke new episodes of heterotopic ossification, it is not possible to predict who will develop a problem and who will not. Trauma of any kind may precipitate an episode of FOP. An injection into the muscle is a type of deep trauma.

A survey of immunization histories of twenty-three FOP patients who were twenty-one years or younger was conducted to ascertain more detailed information regarding risk. This age group was chosen out of the belief that families would have better recall of events and more accurate medical records. The twenty-three respondents (7 males, 16 females) represented 72% of those in the United States with FOP who fell into this age grouping. Sixteen patients (73%) reported no complications as a result of childhood immunizations. Six respondents (27%), all female, developed FOP flare-ups within 6 hours of immunization injection for diphtheria-pertussis-tetanus (DPT). Three of the six reported ossification with no loss of joint mobility. Three other children reported restricted mobility as a result of the injection (1 in the knee, 2 in the elbow). These reactions are not typical side effects for immunization injections, having never been reported by the 80.1 million children immunized from 1978 1990. No problems were reported among FOP patients for the measles-mumps rubella (MMR) vaccination.

In order to help clarify this dilemma of childhood immunizations, I contacted the immunization section of the Center for Disease Control (CDC) in Atlanta, Georgia. This organization is responsible for monitoring immunization policy for the nation as well as for monitoring the spread of infectious diseases of all kinds.

In my conversations with the doctors at the Center, I tried to clarify the fact that immunizations in children with FOP are not "routine," as they often can and often do stimulate new episodes of heterotopic bone formation. For the most part, large scale immunization programs in the general population are a very low risk. In fact, their low risk warrants such public health measures. However, when severe risks are involved for a small group of patients, they must be taken into careful consideration. In other words, for patients with FOP, the known risk of deep intramuscular immunization may be far greater than the small risk of a rare communicable disease.

The physicians at the Center for Disease Control (CDC) wish to consider this matter in further detail, but have discussed with me a set of guidelines which may help in the decision-making process:
1. All immunizations that do not require intramuscular injections should be administered to children with FOP.These include immunization against measles, mumps, rubella and hemophilus influenza.These vaccinations can be given subcutaneously (underneath the skin) with virtually no risk of inciting new bone formation. Also measles, mumps, rubella, and hemophilus influenza infections are very serious illnesses in almost all children and warrant the small risk involved. It is important to remember that these injections may be given subcutaneously.

2. All children should receive the oral polio vaccine. Obviously this poses no risk of inducing heterotopic ossification, as it is an oral vaccine.

3. The standard given into the muscle. Therefore, serious consideration should be given to avoiding this injection. The doctors at the CDC felt that subcutaneous injection of DPT might cause serious skin breakdown around the region of the injection. Therefore, it should NOT be given subcutaneously. The risk of diphtheria is very low. Pertussis (whooping cough) could be treated with antibiotics if it developed. It is also quite rare. The risk of tetanus is also extremely low unless a child experiences a tetanus prone injury. In such a case, the hyperimmune globulin could be given to provide passive immunity should an injury occur. The immunization for tetanus toxoid, while usually given with DPT, can also be given subcutaneously by itself.

4. Hepatitis B immunizations are also recommended only for intramuscular injection. However, a modified subcutaneous administration could be considered.

All states have immunization mandates for children entering school. However, all 50 states, Washington, D.C., and Puerto Rico, offer exemptions through which the legal requirement for immunization can be avoided.

In summary, general recommendations are to proceed with the measles and hemophilus influenza immunizations. Also, children must receive the oral polio vaccine. The decision on whether or not to vaccinate with the DPT injection should be left to the parents and pediatrician who can examine the risk-to-benefit ratio in the context of family and community. However, serious consideration should be given to avoiding the DPT immunization in children with FOP as the risk of inducing new bone formation may far exceed the small risk of infection with diphtheria, pertussis, or tetanus.

For additional information, please consult:
Lanchoney TF, Cohen RB, Rocke DM, Zasloff MA, Kaplan FS. Permanent heterotopic ossification at the injection site after diphtheria-pertussis tetanus immunizations in children who have fibrodysplasia ossificans progressiva. J. Pediatrics, in press, 1995.