Saturday, March 25, 2006

ELIDEL (Pimecrolimus) - Misleading claims for marketing in India

Elidel (PIMECROLIMUS) hs been launched in India for the first time by Novartis for treating Atopic Dermatitis.
I would like to highlight my concern about the marketing for this. The Medical reps and the product monograph state that this is 'safe' for children from 3 months onwards, and tout this as a major advantage over Tacrolimus.
However the international novartis website for ELIDEL clearly states that Elidel should not be used in children below 2 years of age.
Also FDA has recently (march 2005) instructed novartis to put warning labels on this drug in the US which clearly states that this drug is not to be used in children less than 2 years. Also more disturbingly this goes on to state that the long term safety of this drug has not been established and there maybe a small chance of skin and lymphoreticular malignancies in people using this drug, though a causal relationship has not been established. It also advises that this medicine should be used for short term only
http://www.fda.gov/medwatch/safety/2006/Elidel_DHCP_%201-27-06.pdf
This is in complete contrast to the product monographs (in india) which states (on page 53)that "Elidel has an excellent safety profile and induces no clinically significant adverse effects".
On page 54 the monograph further goes on to state that this drug is indicated for long term management of atopic eczema in infants above 3 months of age.
I think that at the very least these issues should be communicated to the pediatricians and the dermatologists who are going to prescribe the medicine to thier patients in good faith. There is no reason for the medicine to be available for infants in India till the time its safety is not proven, and definitely not if their are any concerns about its long term safety.


Thursday, March 23, 2006

Preventing asthma in your child - Precautions before and after birth

All of us who have strong family history of allergies, be it nasal allergy (allergic rhinitis), skin allergy or asthma have a higher than average risk of having kids with allergies. This is more so if both parents (& their immediate family) are sufferring from multple allergies.
In my practice I often find such parents worrying about how to prevent asthma in their newborn child, especially if they already have a child with asthma.
The truth is that we really do not know of any sure shot way to prevent this from happening, but here are a few things that can help;
  • breast-feeding- exclusively for 6 months
  • maternal dietary restriction during breastfeeding - avoiding foods with potential for allergy like milk, nuts, wheat, egg etc. (these maybe avoided during pregnancy also in certain cases with the doctor's consent)
  • late introduction of solids and allergenic foods (milk, nuts, wheat, egg) - again indtroduction of solids after 6 months and allergenic foods probably after 1 year
  • and the use of hypoallergenic infant formulas (this is a new concept, and is still not FDA approved)
As I said before, there is no guarantee that this will work, but it may improve the chances of your kid not getting any major allergies as they grow

Wednesday, March 22, 2006

Antibiotics in babies may cause asthma!

Antibiotics are the wonder drugs from the 20th century. However their success has also been their downfall.
Antibiotic misuse has lead to increasing drug resistance, and nowadays this has lead to a decrease in their prescription by many physicians. Now there is another reason to ask your pediatrician to think again before giving an antibiotic prescription.
A recent canadian study in Chest Medical journal has suggested that those children treated with even a single course of antibiotics under the age of one are twice as likely to develop asthma in childhood as kids who are not given any antibiotics!
It found that for each extra course of antibiotics during the first year of life a child was 1.16 times more likely to develop asthma. What pediatricians and parents need to remember is that most respiratory infections in this age are viral and do not require antibiotics. It is believed that this effect may be as a result of anitbiotics killing the beneficial bacteria in the intestine, leading to alteration of immunity, which perhaps leads to asthma.