Update on Drugs and Drug News: July-August 2011

Human papillomavirus (HPV) test

Cobas® HPV Test
Cobas® 4800 System
F. Hoffmann-La Roche Ltd.

The US FDA approved the cobas HPV test in April 2011 for identifying women at highest risk for developing cervical cancer. It individually identifies genotypes 16 and 18 (the two highest-risk HPV genotypes responsible for >70% of cervical cancer cases), as well as detects 12 other high risk HPV genotypes.

Betamethasone valerate 0.12% foam


Luxiq®

GlaxoSmithKline Inc.

Health Canada approved a prescription only, foam formulation of betamethasone valerate, a midpotency corticosteroid, in May 2011 for the treatment of the inflammatory and pruritic manifestations of corticosteroid-responsive scalp dermatoses.

On June 14, 2011, the US FDA announced changes to sunscreen labeling that would
allow consumers to more easily decipher the commonly used terms on these products. Highlights from this press release include:

• Sunscreen products are no longer able to use the term “broad spectrum” unless they pass FDA efficacy testing for ultraviolet A (UVA) and ultraviolet B (UVB) protection.
• Broad spectrum sunscreens with SPF 15 or higher that meet the FDA’s standards can state that they prevent sunburn, reduce the risk of skin cancer, and limit photoaging when used properly and regularly.
• Sunscreens offering SPF between 2 to 14 with UVA protection can be labeled as “broad spectrum” if they meet FDA testing requirements. However, these products must carry a warning stating that their use has not been demonstrated to contribute to the prevention of skin cancer or premature skin aging.
• The new rules will no longer allow sunscreens to use the terms “waterproof,” “sweatproof ” or “sunblock” on product labels because they are misleading to consumers and do not actually confer the degree of protection as implied. However, the use of “water resistance” is permitted if they are effective for 40 or 80 minutes while swimming or sweating.
• Limiting the maximum SPF value on sunscreens to “50 +” is also under FDA consideration, as there is insufficient evidence supporting improved photoprotection with such products compared to those with SPF 50.
• Due to the unique delivery vehicle characteristics of sprays, the FDA has requested additional efficacy and safety data on these sunscreen formulations. The new regulations will take effect by summer 2012.

The US FDA¹ and Health Canada² issued separate advisories in May and June 2011, respectively, announcing that they are conducting safety reviews of drospirenonecontaining oral contraceptive pills (OCPs) to evaluate their potential for increased risk of venous thromboembolism in women who use these products. Blood clots are a rare but well known side-effect associated with all OCPs. The affected product brands are Yaz® and Yasmin® in Canada, and in the US they include Yaz® (generics Gianvi™ and Loryna™), Yasmin® (generics Ocella™, Syeda™, and Zarah™), Beyaz™, and Safyral™.

In May 2011, the European Medicines Agency (EMA)³ announced that it is updating the product information on OCPs containing drospirenone and ethinyl estradiol (Yasmin®, Yasminelle®, and other products) with respect to the risk of venous thromboembolism.

Two new studies recently published in the British Medical Journal^4,5 suggest the risk of blood clots with drospirenone-containing OCPs may be two to three times greater than with OCPs containing the progestin levonorgestrel.

1. http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_74-eng.php
2. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/05/WC500106708.pdf
3. Jick SS, Hernandez RK. BMJ 342:d2151 (2011 Apr 23). [Epub ahead of print]
4. Parkin L, Sharples K, Hernandez RK, et al. BMJ 342:d2139 (2011 Apr 23). [Epub ahead of print]