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Osteoporosis drugs linked to fracture


The US drug regulator has warned doctors and patients that a category of drugs known as bisphosphonates, commonly prescribed as a cure for osteoporosis, can cause bone fracture.On Wednesday, the Food and Drug Administration (FDA) also asked US manufacturers to change the drug labels to include a warning about this side effect.Two globally popular brands of these drugs are Fosamax from Merck and Co., and Boniva from Genentech Inc.Bisphosphonates have been sold in the Indian market by almost all local drug makers as branded generics for five years. Their labels do not carry such a warning, though experts have been raising concerns about these drugs for at least two years.Even after the FDA alert, there was no word from Indian drug authorities. Calls made to drug controller general Surinder Singh's office and mobile phone on Thursday were not answered.
India has one of the world's largest population of of osteoporosis patients. Government health surveys in 2009 estimated 30 million Indians'mostly women'suffer from the disease, in which bones become porous and brittle. Patients are commonly prescribed bisphosphonates for treatment.But awareness about the side effects of bisphosphonates appears to be low. Mint spoke to two doctors and some patients, who said they did not know about the risk.'We have been continuously writing about the possible side effects, which are in the similar lines, of bisphosphonates for the last couple of years, ' said Chandra M. Gulhati, editor, MIMS, a monthly published directory of drug formulations.'But there were absolutely no action from the drug regulator to warn the doctors or patients in India on such serious side effects,' Gulati added.
He said MIMS had been cautioning readers because one of the side effects is jaw necrosis. In 60% of the cases, the side effect occurs after dental procedure, while in the remaining 40%, it occurs spontaneously due to bisphosphonates' effect.Bisphosphonates drugs used to cure osteoporosis and many other bone diseases as single formulations as well as in combination with vitamin D.Companies selling bisphosphonates-based drugs in India include Elder Pharmaceuticals Ltd, Sun Pharmaceuticals Industries Ltd, Ranbaxy Laboratories Ltd and Natco Pharma Ltd, among others. The drugs are also available through online pharmacies.Elder Pharma, which has the highest market share in the segment, has been selling its brand Bonviva in the domestic market through a licensing agreement with F Hoffman La Roche Ltd since 2006.One of its senior executives said on condition of anonymity that the company is not aware of the FDA alert.Other pharma companies declined to comment on the issue.
The FDA alert said the agency will continue to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment.'In the interim, it's important for patients and healthcare professionals to have all the safety information available when determining the best course of treatment for osteoporosis,' Sandra Kweder, deputy director, office of new drugs at FDA's Center for Drug Evaluation and Research, said in the alert.