Adding more fuel to the fire was a series of isolated adverse events voluntarily reported by consumers and their doctors to the FDA.
Since Protopic was approved in 2000, the FDA has received 10 reports of serious adverse events in children under age 2, and 17 cancers in all age groups. These included non-Hodgkin's lymphoma and skin cancer. Published reports say three of these cancer patients have died.
Elidel, which was approved in 2001, appears to have a similar profile. According to FDA records, from approval in December 2001 through September 2004, there were 54 serious adverse events reported in children under the age of 2, and eight cancers in all age groups, including four in children over the age of 2. The majority of the noncancer events were skin related, and resulted in hospitalization for 15 children.
Creams Used When Steroids Fail
While the number of tumors detected is significant, experts point out it is still small compared with the millions of people using these medications. According to the FDA, nearly 9 million prescriptions were written for Elidel since its approval, with 12.7% prescribed for children between 1 and 2 years old. Although Protopic was on the market sooner, prescriptions for this drug climbed to just 3.5 million, with about 8% given to younger patients, says the FDA.
Other drugs used to treat eczema include steroid medications, which are normally the initial treatment. Experts say both Elidel and Protopic are considered second-string drugs, recommended only when steroid medications fail.
If you are currently using either Protopic or Elidel, Murphy says be certain you are using them only for the conditions for which they have been approved, and only if there are no other treatment options. Experts also say you should talk to your doctor about whether or not you are at increased risk for cancer due to other precipitating factors, including personal and family history of disease.
The FDA is expected to rule on the "black box" warning soon, though it is likely they will take the committee's recommendation.
Published reports indicate both drug manufacturers say there is no clinical evidence of increased cancer risk in humans with either medication. Both companies agree monitoring should continue. Published reports say the companies also plan to review safety data and are planning to continue studies on their own.