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

FDA tightens restrictions on acne drug

 

BY TOMICHEN

14th August, 2005: U.S. officials said on Friday that patients and doctors must register with manufacturers and promise to comply with tight restrictions on Roche Holding AG's acne drug Accutane and generic versions.

The restriction which will take effect on December 31 is part of a plan announced in November 2004 to strengthen safeguards to restrict pregnant women from taking Acutane. Use of this drug may lead to birth disorders or miscarriages, if taken by pregnant women.

The Food and Drug Administration said that the wholesalers and pharmacies should sign up with manufacturers to get the drug from November 1 and pledge to follow distribution rules.

The program is an "unprecedented" effort to manage a serious safety concern of a widely used drug, said Dr. Sandra Kweder, deputy director of FDA's Office of New Drugs. The F.D.A said that about 1.2 million prescriptions are written per year for the drug.

F.D.A changed the existing warnings on Acutane, so that doctors and patients could better identify depression, suicidal behavior and other psychiatric problems that may occur as a result of the use of the drug.

Accutane is also called by the generic name isotretinoin. Mylan Laboratories Inc.  India's Ranbaxy Laboratories Ltd. and Barr Pharmaceuticals Inc. sell generic versions.

All the drug manufacturers said in a statement that they supported the new distribution limits. They also said it was unknown if Accutane caused psychiatric problems.

"If this does not prevent pregnancy exposures, we would consider calling for a withdrawal of the drug from the market," March of Dimes Medical Director Nancy Green said. The March of Dimes works to prevent birth defects. They welcomed the new rules and said that it would closely monitor the effect.

Several voluntary attempts have been made to keep pregnant women from using the drug , but the officials kept on getting reports of pregnancies. The drug was introduced in 1982.

Under the new law, women of child-bearing potential should register with the manufacturers , sign consent forms and be counseled about risks. They must have monthly pregnancy tests to get refills and promise to use two forms of birth control.

The new plan insists that the doctors must pledge to inform patients of possible side effects and check for negative pregnancy tests. Male drug users should sign a form saying that they have been told of the potential risks in using the drug.

The new restrictions follow the report of an advisory panel set up in February 2004 for tighter limits on Acutane.

BY TOMICHEN
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