Lupin’s cholesterol-lowering drug Perindopril recalled in US

The US Food and Drug Administration (USFDA) has recalled all lots of Lupin Pharma's cholesterol-lowering drug perindopril 2 and 4 mg packs of 100's for "not meeting specifications overtime", according to information on US drug wholesaler Morris & Dickson's website.

Lupin, however, has denied the recall. Perindopril is used in cholesterol reduction and also to treat hypertension and congestive heart failure. In February, Lupin recalled 14,000 bottles of Lisinopril 30 mg tablets from the US market, FDA website said.Cholesterol-lowering drug lisinopril, which is manufactured in the company's Goa facility, is one of its largest selling drugs by revenue. It has a total market size of $45 million. When contacted, the company's spokesperson said: "We received a complaint of one bottle of lisinopril tablets containing one tablet of Lupin's imipramine. As an abundant precaution, we voluntarily recalled the batch." The recall is limited to one batch worth around $15,000. However, analysts said the lisinopril recall is not likely to have any major impact on the company's revenue as it involves only a small batch.

Expiration Dates Matter

If your medicine has expired, it may not provide the treatment you need. In this Consumer Update video, FDA Pharmacist Ilisa Bernstein explains how expiration dates help determine if medicine is safe to use and will work as intended.

Indian pharmaceutical industry to reach $20 bn by 2015

Associated Chambers of Commerce and Industry (Assocham) has said it expects the Indian pharmaceutical industry to reach $20 billion by 2015, making it one of the world's top 10 pharmaceuticals markets. 

Also, India's clinical trials business is expected to reach approximately USD 1 billion by 2011, further solidifying the subcontinent as one of the world's preferred destinations for clinical trials, Assocham added.

This has increased the need to address all aspects of pharmacovigilance to ensure delivering medical advances to patients, quickly and efficiently while protecting public health. 

Pharmacovigilance Summit India will take place from 27-29 June in Mumbai this year with regards to these developments.In July 2010, the Ministry of Health and Family Welfare (MOHFW), India, had launched a road-map for pharmacovigilance in the country under the Pharmacovigilance Programme of India (PvPI).

The goal of this programme has been to provide safer medicines for the Indian population. However, the program is faced with many challenges. 

"The sheer number of patients in India is quite sizeable and the issues sometimes conflict between the need to provide access to medicines versus the need to provide safer medicines," National Coordinator PvPI and a key note speaker at Pharmacovigilance Summit India Dr Y K Gupta said.

"The Ministry of Health and Family Welfare, India is planning to address these challenges by allocating a budget head under the MOHFW budget," he added.

International Society of Pharmacovigilance President Dr Alexander Dodoo will present a case study on Africa's experience in developing a robust pharmacovigilance system with limited resources at Pharmacovigilance Summit India. 

The event will bring together regional and global experts to create a dialogue with local and international companies on setting up an advanced drug safety system to optimise resources, and ensure quality and regulatory compliance."Looking at India as the future pharmaceutical hub and with regulators embarking on new initiatives to update and expand methodologies to monitor drug safety, this event couldn't come at a better time," IQPC Conference Director Doaa said.

Diet Drug Orlistat Linked to Kidney, Pancreas Injuries

A review of patients taking the diet drug orlistat  over a seven-year period points to a 2% increase in acute kidney injuries within one year of patients starting the drug.
Separately, drug-safety centers demanding to remove both prescription and over-the-counter orlistat from the market, citing new data obtained from FDA adverse-reaction files, including 47 cases of acute pancreatitis and 73 cases of kidney stones. This is the second time Public Citizen has petitioned the FDA to pull the drug from the market.
Orlistat, which is sold as a prescription drug in Ontario (it is sold both by prescription and over the counter, at a lower dose, in the US), has been linked to "oxalate-induced acute kidney injury" in previous case reports. Back in May 2010, the FDA issued a warning about the risks of severe liver injury with orlistat use, based on 13 reports of liver toxicity in which two patients died of liver failure and three required liver transplants.
Two recent reports of renal injuries prompted Ontario investigators to look at the incidence of new reports of acute kidney injuries (acute dialysis or a hospital diagnosis of acute kidney injury) in their province in the year prior to patients filling orlistat prescriptions and in the year after filling them.
Among 953 new orlistat patients identified between January 2002 and March 2008, five patients experienced an acute kidney injury event in the 12 months prior to starting on the diet drug. By contrast, 18 patients experienced an event within 12 months after filling their prescription (p=0.01). As a "test of specificity," Weir et al also tracked upper-gastrointestinal bleeding in the same fashion ("since there is no plausible reason why orlistat would be associated with this outcome") and found no differences in rates of upper-GI bleeds before and after orlistat prescription.

Invention of Effective Nasal Vaccines could be Possible

It has been reported that there is a possibility of making Nasal Vaccines that accurately protect against flu, pneumonia and even bioterrorism agents such as Yersinia pestis.Dr. Dennis Metzger, from Albany Medical College, explained in a conference how the inclusion of a natural immune chemical with the standard vaccines can boost their protective effect when delivered through the nose.
The respiratory tract is said to be a major entry site for viral and bacterial pathogens with few approved vaccines providing optimal protection against them, due to low immune response at mucosal surfaces such as the nasal passage.However, the combination of standard vaccines for respiratory pathogens with the immune chemical interleukin-12 using an intranasal application to mice has been shown to induce high levels of protection.
During a test done on Vaccines against various respiratory pathogens, it was discovered that Interleukin-12 was a powerful stimulator of the immune response through its interactions with other immune chemicals and the white blood cells that produce them.In addition, Dr. Dennis Metzger, stated that 25% of deaths worldwide and “major killers” are severe respiratory infections, which intranasal vaccination can tackle by inducing immunity in the pulmonary passage.

People With Epilepsy More Prone to Brain Tumors

People with epileptic seizures are much more likely than others to be diagnosed with a brain tumor, a new study indicates. The findings suggest that epileptic seizures may indicate the presence of a very early-stage tumor or a tumor that hasn't been detected on brain scans, the researchers noted. They looked at data on hospital admissions between 1963 and 2005 and subsequent diagnoses of, or deaths from, brain tumors among those patients. The analysis revealed that people who had a first-ever hospital admission for epileptic seizure were nearly 20 times more likely to develop a brain tumor than people admitted to the hospital for other reasons.

Even when the researchers factored in the possibility that brain tumors might have been missed or not recorded in the first year after admission for epilepsy, the risk was still 7.5 to nine times higher for patients with epileptic seizures.The study also found that people with epilepsy were more than 25 times as likely to develop a cancerous brain tumor and more than 10 times as likely to develop a benign tumor than other patients.

The greatest risk was in epilepsy patients aged 15-44, who were 24 to 38 times more likely to develop a brain tumor than people of the same age without epilepsy.The risk of brain tumor persisted for some years after an initial epilepsy-related hospitalization -- up to a more than sixfold greater risk for as long as 14 years.

Brain tumors are rare, even among those with epilepsy, the researchers noted. The overall risk of a brain tumor in 15-to-44-year-olds, for example, was about 1 percent to 2 percent.

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