Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links
PHARMA - ACCUTANE LINKED TO BIRTH DEFECTS

US FDA stalls Roche’ Accutane use in pregnancy

 

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

Pharma News Headlines

Cancer News

Cardiac News

US FDA News

Pharma industry news

LATEST UPDATES

Heart disease deaths more among New Yorkers

Pfizer to offer drugs risk/benefit summary to consumers 

Merck lied to public on Vioxx: lawyer tells jurors

Novartis acquires rights of kidney dialysis drug from SeBo

J&J's Concerta approved treatment of ADHD in teenagers in Canada

US FDA stalls Roche’ Accutane use in pregnancy

Novo Nordisk, Eli Lilly remove insulin products from Australia

British drug supply chain safety questioned after another fake Lipitor find

Wyeth starts support programme for Effexor patients

P&G’s Actonel with Calcium approved for osteoporosis

Pozen gets patent on pain management product

Genmab studies new drug for rheumatoid arthritis

Painkillers may increase blood pressure: study

Nektar buys out Aerogen for $32 m

Predix records positive data on anxiety drug

Insmed files against Increlex approval

Hepatitis A vaccine for kids approved in US

Psoriasis drug data positive: Cytochroma

Novo Nordisk’s 24-hour acting insulin Levemir gets US FDA okay

US FDA approves Teva's generic for osteoporosis 

Pfizer files NDA for Sutent in US

BioVeris licenses Baxter's vaccine portfolio

TheraQuest receives 2nd Orphan Drug status for neuralgia drug

Real-time glucose monitoring device approved in US

Halozyme gets FDA nod for bladder cancer therapy

Migenix to commence phase 2b studies in hep C therapy

Barr gets US FDA okay for clonazepam tabs

Anorexia drug study results positive: Par

GlaxoSmithKline begins phase III trials of new HIV drug

Ranbaxy's 7 anti retrovirals included in WHO list

FDA tightens restrictions on acne drug

Voglibose tabs launched in Japan

Remicade researcher gifts $ 105m to NYU

Par loses ondansetron case to GSK

Mistral starts clinical studies for generic

Carl Icahn sells Mylan shares

Florida sues Mylan, Teva and Watson

Dey and Connecticut settle pricing dispute

Germany set to stop rabies crossing borders

Office to review DTC drug advertisements in US

British docs to be trained in communication, safety

FDA okays acrylic lens for cataract patients 

Corautus to go ahead with angina drug studies 

Americans turn the low-fat way

Chemicals in plastics pose danger

US committee probes doctors’ complicity with Wall Street analysts

Meda buys out rival Viatris

US FDA nod for new levofloxacin regimen to treat acute bacterial sinusitis

Pozen files for new migraine treatment

New therapy for pancreatic cancer under review

New device inducing blood flow to heart granted US patent

NIH announces grants for faster, cheaper DNA sequencing

DOV starts phase III trial of pain drug in US

Alcohol linked cancers: Acetaldehyde in spot light

Hypertension `just above normal’ too risky

Gene causes infertility drugs go awry: study

China’s pig flu outbreak

Cardiac Science-Defibtech lawsuit settled

Peregrine starts Phase-1 anti-viral trial of Tarvacin

Dr. Reddy's launches immune booster for children

Lupin in pact with Kyowa of Japan

Bird flu vaccine may work in humans: US researchers

 

 

Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Latest updates    Contact Us - Feedback    About Us