| Drug Class | Generic/Trade/Company Names | Labelled Indication | Approving Regulatory Agency |
Anti-acne Agent | Chloramphenicol, Sulphur, Hydrocortisone Acetate, 2-butoxyethyl Nicotinate, Allantoin |
| TPP – Canada |
Clindamycin Phosphate |
| TPP – Canada | |
Clindamycin Phosphate |
| TPP – Canada | |
Antibacterial | Levofloxacin |
| US FDA |
Linezolid |
| US FDA | |
Silver Sulfadiazine |
| TPP – Canada | |
Antifungal | Amphotericin B |
| TPP – Canada |
Ciclopirox Olamine 1% |
| TPP – Canada | |
Ketoconazole 2% Cream |
| US FDA | |
Terbinafine HCl 1% Solution |
| US FDA | |
Terbinafine HCl |
| TPP – Canada | |
Terbinafine HCl |
| TPP – Canada | |
Terbinafine HCl |
| TPP – Canada | |
Antihistamines | Loratadine |
| US FDA |
Trimeprazine Tartrate | Antipruritic | TPP – Canada | |
Antiinflammatory | Amlexanox 5% Paste |
| TPP – Canada |
Antipsoriatic | Calcipotriol |
| TPP – Canada |
Antirejection | Cyclosporin |
| US FDA |
Antirosacea | Metronidazole |
| TPP – Canada |
Antiviral | Docosanol Cream 10% |
| US FDA |
Interferon-Alpha |
| US FDA | |
Corticosteroids | Flumethasone Pivalate |
| TPP – Canada |
Prednicarbate 0.1% |
| TPP – Canada | |
Dermatosclerosis | Halofuginone |
| US FDA |
HIV/AIDS | Amprenavir |
| CPMP – Europe |
Lamivudine, Zidovudine |
| US FDA | |
Hormonal | Testosterone Gel |
| US FDA |
Immunomodulators | Tacrolimus Ointment |
| US FDA |
Keratolytic | Diclofenac Sodium |
| US FDA |
5-fluorouracil |
| US FDA | |
Neurotoxin | Botulinum Toxin Type B |
| US FDA |
Oncologic | Alitretinoin 0.1% Gel |
| CPMP – Europe |
Bexarotene Capsules |
| US FDA | |
Bexarotene 1% Gel |
| US FDA | |
Bleomycin |
| US FDA | |
Cyclophosphamide 25mg |
| US FDA | |
Hydroxyurea |
| US FDA | |
Paclitaxel |
| TPP – Canada | |
Pediculocides | Piperonyl |
| US FDA |
Photo-aging | Tretinoin Cream |
| US FDA |
Tretinoin Cream |
| US FDA | |
Scalp | Clobetasol Propionate |
| US FDA |
Topical | Lidocaine & Procaine |
| TPP – Canada |
Transdermal | Estradiol Transdermal |
| US FDA |
Urticaria | Fexofenadine HCl |
| US FDA |
Vaginal | Butoconazole Nitrate |
| US FDA |
Clotrimazole 2% |
| US FDA | |
Estradiol Vaginal Ring |
| US FDA | |
Wound Care | Tissue Engineered |
| US FDA |
Graftskin |
| US FDA | |
“Intelligent” Dressing |
| US FDA |
TPP: Health Canada, Ottawa – Therapeutic Products Program
FDA: United States Food and Drug Administration
CPMP: European Union’s Committee for Proprietary Medicinal Products
Roche Introduces New Drug Warnings
for Accutane in US
As a result of recent meetings held by the US FDA, Roche has introduced further steps to inform
doctors and patients about possible side effects by their anti-acne drug Accutane (isotretinoin), such
as birth defects, mental disorders and suicide.
Doctors must now make sure their patients sign a consent form that explains the drug’s possible risks
before they can write the prescription for this drug. As well, each prescription for Accutane will
include a consumer-friendly pamphlet that details the benefits and the possible side effects.
Accutane labelling already includes both birth defects and mental disorders. Roche has taken several
steps to publicize the drug’s potential teratogenic effects, including an elaborate pregnancy
prevention program, as well as a tracking program monitored by the Slone Epidemiology Unit in
Boston, Massachusetts. However, in spite of this, some women who were taking Accutane became
pregnant each year.
In addition to addressing birth defects as a possible side effect, the new consent forms also advise
patients to look for signs of depression, e.g., feelings of sadness, irritability, fatigue or loss of
appetite. Health officials are not certain whether Accutane does indeed cause problems with
depression, suicidal thoughts and mood disorders.
American Academy of Dermatology
Issues Policy Statement on Accutane
In November 2000, the American Academy of Dermatology (AAD) issued a new policy statement on
Accutane (isotretinoin, Roche), which reads as follows:
- The Academy is committed to the safe and responsible use of isotretinoin.
- The Academy calls on the FDA not to limit the ability of qualified patients, in consultation with
their physician, to receive isotretinoin. - The Academy supports more education for physicians and patients on potential pregnancy
hazards. - The Academy opposes the inclusion of isotretinoin on a list of drugs that can only be obtained
by registered physicians and patients. - The Academy calls for a study designed to determine if there is a direct causative link between
isotretinoin and psychiatric events. - The Academy calls upon the American Medical Association to support its efforts to ensure the
continued accessibility to, and medically appropriate use of, isotretinoin.
The AAD indicated that patient safety is its primary concern, and feels that education of physicians
and their patients, rather than regulation, is the best way to ensure safe and effective results with this
medication.
