FDA Sounds Alarms, But Asks That Patients Remain Calm

In an effort to improve our nation’s beleaguered drug safety system, the Food and Drug Administration plans to post quarterly lists of drugs that are being investigated by the Agency due to safety concerns.  The FDA cautioned that the fact that a drug is included on the list only means that an investigation is ongoing and not that the drug has been determined to be “unsafe.”  This list is part of an overhaul of the FDA mandated by Congress in the aftermath of well-publicized drug safety failures, including Vioxx.

The following drugs are included on the FDA’s list:

Drug and Use
Concern
Suprane – anesthetic Cardiac arrest
Cymbalta – depression Urinary retention
Intelence – HIV Bleeding into joints (hemoarthrosis)
Carac and Kuric – skin creams Potential confusion due to similar names
Heparin – blood thinner Serious allergic or anaphylactic reactions
Humulin-R – insulin

Seroquel – bipolar disorder

R-Gene 10 – growth hormone

Nitrostat – angina Potential confusion over dosing instructions
Stromectol and Warfarin – anti-parasite drug and blood thinner Potential for drug interaction
Tykerb – breast cancer Liver damage
Revlimid – multiple myeloma Severe skin reaction (Stevens Johnson Syndrome)
Tysabri – MS Skin melanomas
Sandostatin LAR – abnormal bone growth Bowel obstruction (ileus)
OxyContin – pain medication Drug misuse, abuse, and overdose potential
Definity – cardiac imaging Cardiopulmonary reactions
Tyzeka – hepatitis Nerve damage (peripheral neuropathy)
Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults
Dilantin – epilepsy Serious skin reactions (“Purple Glove Syndrome”)

The FDA continues to rely upon a troubled adverse event reporting system in addition to reports from manufacturers in an effort to identify potentially-unsafe drugs.  The problem with this system is that it is believed that as few as 1% of safety issues with drugs are ever reported to the FDA by consumers and their physicians.  Also, the FDA’s antiquated guidelines do not require manufacturers to report every adverse event of which it may become aware, and such reporting is done on the honor system.  The new quarterly list will not include drug safety investigations that have been prompted by red flags received from clinical trials and studies.

While the FDA’s efforts are to be applauded, they are only one piece of the drug safety puzzle.  The other very critical piece is the civil tort system.  Unfortunately, the ability of our court system to hold manufacturers accountable for dangerous drugs that harm consumers is currently under assault through back-door federalization and preemption efforts.  It is critical for the civil tort system to continue to play a role as an advocate for injured victims; an important part of the checks and balances.  The FDA has admitted the significant limitations to its ability to truly safeguard consumers from dangerous drugs, so it would be a travesty to remove the safety net provided to injured patients by the civil justice system.