FDA Says Certain Type 2 Diabetes Drugs Can Cause Serious Joint Pain, The U.S. Food and Drug Administration said in a safety alert Friday that some widely used treatments for Type 2 diabetes can cause severe and disabling joint pain, raising concerns for a big-selling class of drugs.
The FDA alert applies to a category of pills known as DPP-IV inhibitors, which include Merck & Co.’s Januvia, AstraZeneca PLC’s Onglyza, and Tradjenta from Eli Lilly & Co. and Boehringer Ingelheim GmbH. Doctors prescribe the drugs, which hit the U.S. market beginning in 2006, to help people with the most common form of diabetes keep their blood-sugar levels in check.
The FDA said in the safety alert that patients shouldn’t stop taking the drugs but should contact their doctors if they experience severe and persistent joint pain. Doctors should stop prescribing the drugs to patients experiencing joint pain if the drugs are suspected of being the cause, the agency said.
The FDA said it identified cases of severe joint pain associated with the use of DPP-IV inhibitors in a review of medical literature and adverse events reported to the FDA. Symptoms usually went away after patients stopped taking the drugs, the agency said. The agency added warnings and precautions about the joint-pain risk to the drugs’ prescribing labels.
Merck’s Januvia has dominated the DPP-IV market and is the company’s highest-selling drug, generating about $1.9 billion in sales for the first six months of 2015. A combination drug containing Januvia, Janumet, had $1 billion in sales for that period.
But prescription volume for DPP-IV inhibitors overall has slowed in recent years due to new competition from other diabetes drugs, as well as occasional safety concerns. One of the drugs, Onglyza, was associated with an increased risk of hospitalization for heart failure in a clinical study. In April, an advisory panel to the FDA recommended that new warnings be added to Onglyza’s prescribing label about the heart-failure risk.
A spokeswoman for Boehringer Ingelheim said the company and its partner Lilly are confident in the benefit-risk profile of Tradjenta and combination drugs that contain it. There were no significant differences in rates of joint pain between Tradjenta and placebo in clinical trials of the drugs, and there have been a “limited number” of reports of serious joint pain among users since they reached the market, the spokeswoman said.
A Merck spokeswoman said severe joint pain is a rare occurrence reported in a small number of patients taking Januvia-containing drugs. She said Merck worked with the FDA in its review, and the company is confident in the safety profile of Januvia.
An AstraZeneca spokesman said the company monitors the use of its medications and works with health authorities to help patients and doctors understand its drugs’ risk-benefit profiles.
The FDA alert applies to a category of pills known as DPP-IV inhibitors, which include Merck & Co.’s Januvia, AstraZeneca PLC’s Onglyza, and Tradjenta from Eli Lilly & Co. and Boehringer Ingelheim GmbH. Doctors prescribe the drugs, which hit the U.S. market beginning in 2006, to help people with the most common form of diabetes keep their blood-sugar levels in check.
The FDA said in the safety alert that patients shouldn’t stop taking the drugs but should contact their doctors if they experience severe and persistent joint pain. Doctors should stop prescribing the drugs to patients experiencing joint pain if the drugs are suspected of being the cause, the agency said.
The FDA said it identified cases of severe joint pain associated with the use of DPP-IV inhibitors in a review of medical literature and adverse events reported to the FDA. Symptoms usually went away after patients stopped taking the drugs, the agency said. The agency added warnings and precautions about the joint-pain risk to the drugs’ prescribing labels.
Merck’s Januvia has dominated the DPP-IV market and is the company’s highest-selling drug, generating about $1.9 billion in sales for the first six months of 2015. A combination drug containing Januvia, Janumet, had $1 billion in sales for that period.
But prescription volume for DPP-IV inhibitors overall has slowed in recent years due to new competition from other diabetes drugs, as well as occasional safety concerns. One of the drugs, Onglyza, was associated with an increased risk of hospitalization for heart failure in a clinical study. In April, an advisory panel to the FDA recommended that new warnings be added to Onglyza’s prescribing label about the heart-failure risk.
A spokeswoman for Boehringer Ingelheim said the company and its partner Lilly are confident in the benefit-risk profile of Tradjenta and combination drugs that contain it. There were no significant differences in rates of joint pain between Tradjenta and placebo in clinical trials of the drugs, and there have been a “limited number” of reports of serious joint pain among users since they reached the market, the spokeswoman said.
A Merck spokeswoman said severe joint pain is a rare occurrence reported in a small number of patients taking Januvia-containing drugs. She said Merck worked with the FDA in its review, and the company is confident in the safety profile of Januvia.
An AstraZeneca spokesman said the company monitors the use of its medications and works with health authorities to help patients and doctors understand its drugs’ risk-benefit profiles.
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