Can my child get recurrent episodes of Hand Foot Mouth Disease ?

Q: My 4 year old had Hand Foot Mouth Disease (HFMD) around 1 year back. Now he is having the same symptoms of rash in feet, hands and mouth ulcers again, can this disease recur?

Ans: This is certainly an unusual situation. Here is what Dr Greene has to say about this ...
Hand-foot-and-mouth syndrome is a distinct viral illness. It produces blisters in the mouth in 90% of infected children and a characteristic rash primarily on the hands, feet, or buttocks in 64% of these children. Most children are cranky, with a sore throat, decreased appetite, and/or fever. The illness typically clears within a week.

Hand-foot-and-mouth syndrome was first reported in 1956, in Australia. As far as we know, it never occurred before that time. For the next 7 years it was reported, only occasionally, in pockets dotting the globe. By 1963, however, it became a common feature of childhood worldwide.

Hand-foot-and-mouth syndrome is caused by several different viruses, including coxsackieviruses A5, A9, A10, A16, B1, B3, enterovirus 71, foot-and-mouth disease virus, and herpes simplex. The vast majority of cases, however, are caused by coxsackievirus A16.

A child with a healthy immune system will form antibodies to whichever virus caused the infection. If your son is re-exposed to the same virus, he will probably not be re-infected. He is still susceptible, in varying degrees, to the other viruses. Since 1963, most children have had one case of hand-foot-and-mouth syndrome, caused by coxsackievirus A16.

There is one other snag. While most children clear their bodies of the virus within one week, coxsackievirus A16 occasionally succeeds in hiding inside children’s own cells, like herpes. By eluding the cellular immune system, coxsackievirus A16 can cause chronic or recurring skin lesions. Healthy humoral immunity is able to keep these recurrences from being as severe as the initial episode.

Will your son catch hand-foot-and-mouth syndrome again? Probably not, but there are no guarantees. Who knows? In the next century, enterovirus 71 might become the major cause of hand-foot-and-mouth syndrome. Even so, the human immune system has a remarkable history of adapting to the ever-changing microscopic world around us.

Source 

So the answer is that your child can get it again, but if we help keep the immunity high then the chances of recurrence are less, and the severity of the disease is likely to be lesser too.

Caution to Pediatricians (& Parents) - Fake Vaccine(s) in India

This letter has been sent by the Indian Academy of Pediatrics to all members (mro9e than 20,000 pediatricians in India) counseling them regarding the availability of fake PENTAXIM (manufacturer - Sanofi Pasteur) in India. Here is the letter reproduced in its entirety

"Dear Colleagues,We would like to apprise you regarding a serious matter where a renowned vaccine manufacturer, Sanofi Pasteur has identified and come across a suspected counterfeit pentavalent vaccine, Pentaxim available in Cuttack, State of Orissa, in the eastern part of India. The vaccine pack has copied the brand but glaring errors on the pack indicate that the product is spurious. They have immediately informed concerned health authorities as well as enforcement agencies and asked them to investigate the matter and bring the culprit to book.IAP strongly condemns and expresses serious concern on the issue of availability of counterfeit products in the Indian market. We also urge our paediatric community to ensure that products are purchased through authorized distributors only through proper invoices and carefully check the packaging for any visible errors. In case of any questions and concerns, we request you to get in touch with the central IAP and the respective manufacturer to ensure that quick action is taken at the local and central level.Let us come together as a pediatric community and be vigilant to ensure we protect the health of the Indian children by using genuine products.Dr. Vijay YewaleIAP President 2014"

Off-Label Pediatric Drug Prescribing: American Academy of Pediatrics Updates Guidelines

Diedtra Henderson

February 24, 2014

Because more than half of the medications approved for marketing by the US Food and Drug Administration (FDA) lack evidence of safe and effective use in pediatric patients, the practice of medicine will "more than likely" require that practitioners prescribe medicines off-label to appropriately treat pediatric patients, according to the American Academy of Pediatrics (AAP).

The group published an updated policy statement on the topic online February 24 in Pediatrics.

The AAP last issued a statement on off-label use of prescription medicines in 2002 and reaffirmed it in 2005. Since then, more than 500 medicine label revisions have been made by the FDA to reflect information about use in pediatric patients, a trend accelerated by passage of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Acting as complementary federal sticks and carrots, the PREA mandates that almost all new medicines be studied in children if pediatric use of the product is likely, whereas the BPCA opens the door for an additional 6 months of market exclusivity for sponsors that submit completed pediatric studies to the FDA.

Still, the number of pediatric-tested remedies is exceeded by the number of FDA-approved prescription medicines that have not specifically been tested for safe and efficacious use in pediatric patients.

The AAP statement indicates that clinicians' decision making in this instance "should always be guided by the best available evidence and the importance of the benefit for the individual patient. Practitioners are in agreement regarding the importance of practicing evidence-based medicine. However, for the pediatric population, gold standard clinical trials are often not available, so practitioners must rely on either less definitive information, such as expert opinion for the age group that they are treating, or use evidence from a different population to guide practice."

The FDA does not regulate the practice of medicine, according to the statement. "The administration of an approved drug for a use that is not approved by the FDA is not considered research and does not warrant special consent or review if it is deemed to be in the individual patient’s best interest," the policy statement explains.

"To conform to accepted professional standards, the off-label use of a drug should be done in good faith, in the best interest of the patient, and without fraudulent intent," according to Kathleen A. Neville, MD, from the AAP Committee on Drugs, and coauthors.

According to the statement,

• clinicians are responsible for deciding which medicine at which dose the pediatric patient will receive for which purpose;
• pediatricians should continue to advocate for incentives and requirements that promote the study of medicines in children;
• physician researchers should conduct well-designed pediatric drug studies or collaborate in them;
• journals should publish studies about well-designed trials, irrespective of the results; and
• institutions and payers should not settle for label revisions as the sole determinant of which medicines to include in formularies.

The statement draws a distinction between individual clinician decision making on the behalf of individual patients and the active promotion of off-label use that is prohibited, whether by the sponsor or by the clinician speaking on behalf of the sponsor.

Truly investigational off-label prescriptions should be done in the context of a well-designed clinical trial, the statement indicates. Patients and their legal guardians should be duly informed, and clinicians should document consent to proceed. In addition, because off-label prescriptions can heighten liability risks for practitioners, the statement counsels clinicians to document their decision-making process in the patient's record.

"Off-label drug use remains an important public health issue, especially for infants, young children, and children with rare diseases," Dr. Neville and the AAP committee coauthors conclude. "Evidence, not label indication, remains the gold standard from which practitioners should draw when making therapeutic decisions for their patients."

The study authors have disclosed no relevant financial relationships.

Pediatrics. Published online February 24, 2014.

COMMENTS: This is an important document, since many drugs, especially cold medications that are used in children in India are also not approved below 2 years age. Pediatricians can thus continue to use some medicines off-label if they feel that the individual benefits are likely to exceed potential side-effects, and no alternatives exist.