The FDA is “evaluating” new adverse-event reports for 20 drugs, the agency announced today.
A 2007 federal law requires the FDA to disclose all its investigations into reports of possibly drug-related adverse events. Today’s list is the first of this series of quarterly reports.
The list includes adverse events reported between Jan. 1 and March 31, 2008. FDA officials say it will be “weeks or months” before more recent reports are made.
All of the reports on the list come from the FDA’s early-warning system for drugs already on the market. This Adverse Event Reporting System (AERS) collects reports from patients, hospitals, doctors, and drug companies about suspicious problems that might — or might not — be related to a medication.
“If a drug is listed, it means we have begun an analysis to see if there is a safety problem that requires further evaluation,” Gerald Dal Pan, MD, MPH, director of the FDA office of surveillance and epidemiology, said at a news conference.
When that evaluation is done, the FDA will either issue further warnings or an all-clear, Dal Pan said.
Here’s the list of drugs and the “adverse events” — side effects — reported to the AERS database:
1) Arginine Hydrochloride Injection (R-Gene 10) – Pediatric overdose due to labeling / packaging confusion
2) Desflurane (Suprane) – causes cardiac arrest (heart stops working) – death
3) Duloxetine (Cymbalta) – causes urinary retention
4) Etravirine (Intelence) – Hemarthrosis (blood in a joint)
5) Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) Adverse events due to name confusion
6) Heparin Anaphylactic-type (life-threatening allergic) reactions – causes death
7) Icodextrin (Extraneal) – Hypoglycemia (low blood sugar)
causes low blood sugar
8) Insulin U-500 (Humulin R) – Dosing confusion
9) Ivermectin (Stromectol) and Warfarin – Drug interaction
10) Lapatinib (Tykerb) – Hepatotoxicity (liver toxicity) causes liver disease
11) Lenalidomide (Revlimid) – Stevens-Johnson syndrome (a deadly drug reaction) causes death
12) Natalizumab (Tysabri) – causes skin cancer – melanomas (deadly skin cancer)
13) Nitroglycerin (Nitrostat) – Overdose due to labeling confusion
14) Octreotide Acetate Depot (Sandostatin LAR) Ileus (bowels not moving) causes constipation
15) Oxycodone Hydrochloride Controlled-Release (OxyContin) Drug misuse, abuse, and overdose
16) Perflutren Lipid Microsphere (Definity) – Causes cardiopulmonary reactions (lung/heart problems)
17) Phenytoin Injection (Dilantin) – Causes purple glove syndrome (discoloration, pain, and swelling of the hand that may lead to amputation)
18) Quetiapine (Seroquel) – Overdose due to sample pack labeling confusion
19) Tebivudine (Tyzeka) – Causes peripheral neuropathy (tingling or numbness in the extremities)
20) Tumor Necrosis Factor (TNF) Blockers – Causes cancers in children and young adults
The report does not say how many people were affected by these possible drug reactions, nor does it give any indication of their severity.
“Our safety evaluators will look at the seriousness of the event, whether we are seeing greater numbers of a certain kind of event we should not expect, whether there is something new and not known about the drug, or whether this is something known but which may require refinement of our knowledge,” Dal Pan said.
“This extends our commitment to keep the public and the health care community informed of what we are evaluating,” Paul Seligman, MD, MPH, FDA associate director of safety policy and communication, said at the news conference.
According to Dr. Robert O. Young, a research scientist at the pH Miracle Living Center, “there is not a drug on the market that I have not tested that helps to restore the alkaline design of the body. All drugs are acidic and therefore have side-effects that can compromise long-term health and fitness. The best drug that one can take is education. When one is educated on how to achieve incredible health, energy and fitness they find out that the body needs “NO MEDICATION”! The body is NOT suffering from a DRUG deficiency. The body needs more alkalinity from an alkaline lifestyle and diet. This alkalinity can be achieved with more fresh air, pure alkaline water (at least 4 liters a day), alkaline salt (8 to 10 grams), daily saturation of sunlight (at least 20 minutes a day), 3 to 4 ounces of long chain fats from flax, hemp, avocado, etc., liberal amounts of alkaline fruits and vegetables (12 to 16 servings daily) and alkaline exercise (at least 1 hour of aerobic exercise each day). The result or side-effects for those who choose an alkaline lifestyle and diet will always be increased energy, fitness and health! So, say NO To ALL MEDICATIONS and YES to EDUCATION and ALKALINITY. I believe it improve the quality and quantity of your life.”