Refer, also, to the letter from the Division of Drug Marketing, Advertising and Communications of the United States Food and Drug Administration, dated September 29, 1998, which says, in part, that "The [recent broadcast] advertisement [for Aldara] does not adequately present the important adverse events associated with the use of Aldara Cream, nor appropriately communicate the frequency with which such events occur..." The letter concludes by requiring 3M Pharmaceuticals, the US manufacturer of Aldara, to affirm that it has stopped the broadcast advertisement, and to state "a plan of action for the discontinuation of all violative print material" [6].

The following is the passage I wrote on December 25, 2009, for the Aldara ratings site at askpatient.com:

My dermatologist prescribed Aldara twice – in March 2009 and October 2009. Each course of treatment consisted of 12 applications, for which there were 12 sachets of the drug. I was to apply Aldara (mainly to my forehead) for five days, take two days off, apply it for another five days, take two days off, and then apply it for two days. I didn't have bcc; just a few minor lesions. My dermatologist said the Aldara would clear these up and reduce the risk of bcc developing in the future. There was no warning of possible side-effects, except that I would look "a bit of a mess" for a while. And I have to say that, the first time I used Aldara, I suffered no side effects that I remember (apart from the local effects on the skin). But five days after I started using it in October, I came down with flu-like symptoms. At first, I thought I did have a touch of flu – and continued to apply the cream. But after six days of pain, for which I took codeine, paracetamol and aspirin at night, I suspected the Aldara was to blame, and did a Google search for "Aldara+side effects". I read some of the testimonies I found on the first page of Google results, which were enough to persuade me not to use the three remaining sachets of the drug. The pain continued for about five more days, but affected a smaller and smaller area until it was eventually confined to my lower legs and ankles. The end of the pain was not the end of my troubles, however, as I then suffered a hemorrhage in my right eye, which left half of it badly bloodshot for three weeks. (The aspirin was probably partly to blame for this.) After another four weeks or so, my eye still hasn't completely returned to normal.

All I can say for Aldara is that it did clear up two or three small areas of suspect skin on my face. But I have no doubt that these could have been treated more safely and equally effectively by other means. I would never have used Aldara for the treatment of such a minor problem if I had known that it "activated", "stimulated" or "modified" the immune system. One does not have to have spent a single day in medical school to know that any such action could have devastating consequences. I am convinced my use of Aldara, which attacks mucous membranes [3], was to some degree responsible for the hemorrhage in my eye, as my use of aspirin was not excessive [9]. Moreover, bloodshot eyes are reported by other users, including Tom Clarke [7] and Rita Kelly [8]. If you have used Aldara, and have suffered severe side-effects, I suggest you report your experience at askpatient.com and medications.com. You should also visit doctorsaredangerous.com and yourlawyer.com – where Aldara is listed as a defective drug.

If you would like to record your experience of Aldara on this website, send me your testimony via my feedback form. In view of the high cost of Aldara, I would be interested in seeing any evidence that doctors are receiving kickbacks for prescribing it. – Alan Ireland, PO Box 2052, Palmerston North 4440, New Zealand

NOTES:

1. In 2004, the FDA's approval of Aldara "provides for the use of Aldara (imiquimod) Cream, 5% for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured".

2. The aldara.com website states: "Aldara Cream works from within by activating the body's own immune system. When Aldara Cream is applied to the skin, immune cells are activated and travel to the area. For example, in the case of genital warts, the activated immune cells work to eliminate cells that have been infected with the human papillomavirus (HPV) that causes the warts. Aldara has no direct antiviral activity and is not chemodestructive or cytotoxic. The clinical relevance of these findings and the mechanism of action of Aldara cream in treating actinic keratosis and superficial basal cell carcinoma are unknown." To view the relevant page, click here.

3. "The active ingredient in Aldara is Imiquimod which activates the body's immune response through the Toll-like receptor. [Hemmi, H., et al. Small anti-viral compounds activate immune cells via the TLR7 MyD88-dependent signaling pathway. Nat Immunol.. 2002 3(2):196-200.] Imiquimod disrupts the cytokine activity and simultaneously attacks the body's mucus membrane tissues. Cytokines are important for proper immune system response and any disruption might lead to autoimmune diseases such as psoriasis, diabetes, rheumatoid arthritis, etc." – creamaldara.com.

4. "Aldara (imiquimod 5%) Cream is an immune response modifier for topical administration. Each gram contains 50mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben. Chemically, imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C14H16N4 and a molecular weight of 240.3." – RxList, the Internet Drug Index.

5. To view the relevant page, click here.

6. This letter can be found at the FDA site.

7. "I have used Aldara a couple of times and the redness and ugly sores to clear up. But I just realized that when you use too much, there are side effects...I have been very tired, bloodshot eyes, headachy, head full of mucus feeling, and atrial fribillation (which I have been under medication for, but with the Aldara, the medication did not seem to work too well), dizziness at times. The doc just told me that when you use more than one pack every onther day (ie treating a larger area or areas), the chances for the side effects really increase. Anyone else getting some of these symptoms?" – Tom Clarke, November 25, 2008, at Topix.

8. "My eyes were bloodshot, my skin dried out, and my hair became "straw-like". – Rita Kelly, Toomey's Road, Mt Elliot, NSW 2250. (From a letter to Elaine Hollingsworth at Doctors Are Dangerous.)

9. Record of use of analgesics: Nov. 7, 2009: 2 codeine (30mg) after going to bed. Nov. 8: 2 codeine + 1 Panadol (contains 500mg paracetamol). Nov. 9: 1 codeine + 1 Panadol. Nov. 10: 1 codeine + 1 Panadol. Nov. 11: 2 codeine + 1 Panadol. Nov. 12: 2 Aspro Clear (1 tablet contains 500mg aspirin) during the course of the night – the last night on which I applied Aldara. Nov. 13: 1 Aspro Clear. Nov. 14: 1 Aspro Clear. Nov. 15: 1 Aspro Clear. Nov. 16: Had some pain in my ankles, but managed to get through the night without taking any painkiller. Nov. 17: Pain stopped.