Isotretinoin generics face withdrawal threat in US as new study links acne drug to bowel disease

Ranbaxy has a generic version of isotretinoin (Accutane) in US market branded as Isotret

Isotretinoin (Accutane), one of the widely prescribe drug to treat severe acne in teenagers and young adults is facing a withdrawal threat from US FDA following a new study endorsing the drug’s potential to cause inflammatory bowel disease, reports said.

Researchers from the University of North Carolina, Chapel Hill, presented evidence showing a higher rate of bowel disorders in isotretinoin users, at the annual meeting of the American College of Gastroenterology in San Diego.

Users of Isotretinoin (Accutane) have almost twice the odds of developing a serious bowel disorder as nonusers, the new study found.

On comparing 8,189 cases of inflammatory bowel disease with 21,832 healthy individuals Dr. Seth Crockett and his colleagues found the odds of developing such diseases were 1.68 times higher among isotretinoin (Accutane) users.

People who had filled four or more isotretinoin (Accutane) prescriptions had 2.67 times the risk. The odds of having ulcerative colitis were 4.36 times higher among isotretinoin users. Ulcerative colitis is a type of bowel disease that causes open sores in the lining of the rectum and colon. However, no increased risk was found for Crohn’s disease, perhaps the most severe such ailment.

Inflammatory bowel disease causes the intestines become chronically red and swollen, producing pain, cramping, diarrhea, weight loss and bleeding. Surgery to remove all or part of the colon is sometimes required to cure inflammatory bowel disease.

But only about 5 to 10 people in 100,000 are diagnosed with inflammatory bowel disease each year, Crockett has stated.

“The absolute risk of getting inflammatory bowel disease is very low,” Crockett was quoted as saying. “So if someone has disfiguring acne that was affecting their quality of life, it might be a risk they are willing to take.”

The study also does not explain how and why isotretinoin might increase the risk of bowel disease.

Before the study, the connection isotretinoin (Accutane) with inflammatory bowel disease was largely anecdotal.

Crockett’s data may still be considered preliminary as findings have not yet been published in a peer- reviewed journal.

Another study, published in July in the American Journal of Gastroenterology by University of Manitoba researchers, came up with no evidence associating isotretinoin (Accutane) with inflammatory bowel disease. That study examined a large database in Canada and found that 1.2% of people diagnosed with inflammatory bowel disease had used isotretinoin (Accutane) before diagnosis, compared with 1.1% who had not used isotretinoin.

Isotretinoin (Accutane) has been plagued by various sort of problems since in approval in 1982.

Isotretinoin (Accutane) was implicated to cause birth defects if taken during pregnancy and was labeled with warnings to that effect.

In 2005, the Food and Drug Administration implemented the stringent iPledge program, requiring patients, doctors and pharmacists to join a risk-management registry to try to ensure that women didn’t become pregnant while using isotretinoin (Accutane).

Isotretinoin (Accutane) can cause other side effects, including increased sensitivity to the sun, joint and muscle pain, headaches, thinning hair, elevated cholesterol and liver toxicity.

Isotretinoin (Accutane) has also been linked to an increased risk of depression, including suicides.

Some families of suicide victims have pressed US FDA for its removal of Accutane from the market.

Plaintiffs have won an estimated $33 million in judgments against Roche for bowel disorders, according to Dermatology Times.

However, studies published in the Annals of General Psychiatryfound that the relationship between isotretinoin and psychiatric problems is unproved.

Swiss-based Roche Holding, make of the drug withdrew its blockbuster drug Accutane the market in June in view of some earlier concerns that the drug may be linked to inflammatory bowel disease. Isotretinoin (Accutane) was one of Roche’s best-selling drugs.

Isotretinoin is form of vitamin A. Isotretinoin is usually taken daily for three to six months. Isotretinoin often result in lasting improvements in 99% of patients and a cure in about 70%. No medication is as effective in treating severe cases of acne as isotretinoin.

Isotretinoin is also used occasionally for psoriasis, lupus and cancer.

Isotretinoin (Accutane) has been used by more than 13 million people worldwide.

Isotretinoin (Accutane) was having sales about $200 million a year before its patent expired in 2002.

Generics of isotretinoin costs 25% to 50% less than Accutane which costs costs about $1,200 a month.

Several generic versions of isotretinoin is currently available in market. Sotret from (Ranbaxy), Amnesteem (Mylan), Claravis (Barr), Clarus (Prepharm), Decutan (Actavis), Isotane (Pacific Pharmaceuticals), Izotek (BlauFarma), Oratane (Genepharm Australasia), Roaccutane (Roche). Topical solutions of isotretinoin is most commonly marketed under the trade names Isotrex or Isotrexin (Stiefel).

In July, Ranbaxy recalled one batch of Sotret from the market following US FDA recommendation.

Sotret is one of the top selling drugs of Ranbaxy Laboratories.

Ranbaxy voluntarily recalled a single lot of Sotret (isotretinoin) capsules of 40 milligram strength from the US market, the company said in a statement.

US FDA approved Ranbaxy’s generic version of isotretinoin in 2003.

Generic drugs maker Ranbaxy Laboratories, which has been acquired by the Japanese Daiichi Sankyo, however, the company clarified that this is a class III recall, which signifies that the use or exposure to the product is not likely to cause adverse effects.

Ranbaxy Laboratories has, recently, acquired trademarks, product dossiers and marketing rights from Ochoa Laboratories Limited for its entire range of dermatological and lifestyle products, as part of its efforts to consolidate its position in skincare segment.