Washington, DC: The US food and drug administration, or FDA, on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health care professionals as early as possible.
The list includes a wide array of drugs, from Eli Lilly and Co.’s antidepressant Cymbalta to Purdue Pharma Lp.’s painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated.
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FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers—such as Johnson and Johnson’s Remicade—as being potentially associated with cancer in children. In June, FDA said it was investigating the possible link.
TNF blockers target a compound known as tumour necrosis factor, which is overproduced in many patients with inflammatory diseases such as arthritis and Crohn’s.
But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp.’s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but FDA hasn’t previously said it was investigating the drug for this side effect.
The list, which FDA will start issuing quarterly, is aimed at giving consumers and health care professionals early indications of what FDA is investigating, but it might end up creating more confusion.
Indeed, the agency is concerned “that people will stop taking a drug inappropriately” because it is on the list, said Paul Seligman, associate director of safety policy at the agency.
FDA said it alerted companies whose drugs appeared on the list prior to it being made public—several companies said they received word late Thursday—and intends to give drug makers a heads-up in the future as well.
Drug makers said they support FDA’s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.
“It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,” said Tony Jewell, a spokesman for AstraZeneca Plc.
AstraZeneca’s psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labelling.
Companies also cautioned that just because a drug is posted on the site doesn’t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.
FDA’s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn’t represent a comprehensive list of drugs FDA is investigating, FDA’s Seligman said.
The report is generated from the agency’s adverse-event-reporting database.
That compilation consists of voluntary reports frompatients and health care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.
Seligman said FDA is hopeful the quarterly reports will encourage people to report adverse events.