BY OUR PHARMA CORRESPONDENT
18th August,2005: Following reports linking Roche’s anti-acne treatment Accutane with birth defects, US Food and Drugs Administration has enforced tighter safeguards to prevent pregnant women using Accutane.
FDA said it had approved a strengthened distribution programme for Accutane, also known under its generic name Isotretinoin, requiring doctors and patients to register and accept specific responsibilities before receiving authorisation to prescribe or use Accutane.
Under the new plan, women of child-bearing potential must sign consent forms, be counselled about risks, have monthly pregnancy tests and promise to use two forms of birth control. Doctors must pledge to inform patients of potential side effects and check that pregnancy tests are negative.
Apart from Roche, other generic manufacturers of the drug including generic firms Genpharm, Mylan, Barr and Ranbaxy, will implement the computer and telephone-based registry, called iPledge. Wholesalers and pharmacies that do not register to the scheme will no longer have supplies of the pills shipped to them.
“This programme is about as tight as we can legally make it. If a pharmacist, a wholesale drug company or a physician does not wish to participate in this programme, then they will not have access to the drug,” stated FDA Commissioner Lester Crawford.
However, the March of Dimes, a health advocacy group that works to prevent birth defects, said it would closely monitor the scheme to see if it worked. “
Since Accutane began selling in 1982, the FDA has had reports of more than 160 babies born with drug-related defects. The agency estimates that 100,000 US prescriptions of Accutane are filled each month.
Accutane contains isotretinoin, a form of vitamin A. It decreases the amount of sebum (oil) that is released by the sebaceous (oil) glands, and it increases that rate at which the skin renews itself. Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics. However, isotretinoin can cause serious side effects. However the safety instructions over the drug read:
* Do not take isotretinoin if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking isotretinoin. Isotretinoin is in the FDA pregnancy category X. This means that isotretinoin is known to cause severe birth defects in an unborn baby. It can also cause miscarriage, premature birth, or death of the baby. You must take a pregnancy test and have negative results when you and your doctor decide that isotretinoin may be beneficial for your condition. You must have a second pregnancy test with negative results during the first 5 days of the menstrual period right before you start taking isotretinoin. Two reliable forms of birth control must be used at the same time (unless abstinence is the chosen method of birth control or if you have undergone a hysterectomy) for one month before starting treatment with isotretinoin, during treatment with isotretinoin, and for at least 1 month following the end of treatment. You will also be asked to take a pregnancy test on a monthly basis. Your doctor will discuss with you and provide for you a video and written information regarding choices for birth control, possible causes for birth control failure, and the importance of using birth control while taking isotretinoin. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking isotretinoin and notify your doctor.
Some patients have experienced depression (including feelings of sadness, irritability, unusual tiredness, trouble concentrating, and loss of appetite) and suicidal thoughts and/or behavior during, and soon after stopping, treatment with isotretinoin. Notify your doctor immediately if you begin to experience signs of depression or if you begin to have thoughts about taking your own life during or shortly following treatment with isotretinoin.
* Do not take vitamin supplements containing vitamin A during treatment with isotretinoin. This could cause increased side effects.
* Do not donate blood while taking isotretinoin and for at least 1 month following the end of treatment. Blood donated while taking isotretinoin may be given to a pregnant woman and be harmful to her baby.
* Do not use wax hair removal systems or have any skin resurfacing procedures (such as dermabrasion or laser treatment) performed while taking isotretinoin and for six months following treatment due to the possibility of scarring.
* Avoid exposure to sunlight or UV rays while taking isotretinoin. Isotretinoin may increase the sensitivity of the skin to sunlight and a severe sunburn could result.
* Use caution when driving a vehicle at night. Isotretinoin can cause decreased night vision. The onset of decreased night vision may be sudden.
* Take all of the isotretinoin that has been prescribed for you even if your symptoms start to improve. The acne may seem to get worse at the start of therapy, but should then begin to improve. For the best results, finish all of the medication that has been prescribed. You may require more than one course of therapy with isotretinoin.
Roche is a leading healthcare company with a broad spectrum of healthcare related activities. Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
BY OUR PHARMA CORRESPONDENT