Federal drug regulators are moving to enforce a ban on prescription drugs with more than 325 milligrams of acetaminophen. But you'll still be able to buy pills that contain up to twice that dose over-the-counter at the gas station or grocery store
Earlier this week, the US Food and Drug Administration (FDA) urged health care providers to stop writing prescriptions for pain relievers containing more than 325 milligrams of acetaminophen, the active ingredient in Tylenol.
The agency’s announcement was aimed primarily at popular prescription medicines that combine acetaminophen with a more powerful opioid such as hydrocodone. Agency officials said they had determined that “there are no available data” to show that the benefits of having more than 325 milligrams of acetaminophen in a single pill outweighed the risks from taking too much of the drug.
The announcement followed up on a similar 2011 FDA admonition to drug makers and was the latest turn in a long-running deliberation over the regulation of acetaminophen.
As documented in a ProPublica series last year, the FDA has delayed for decades enacting tougher rules on acetaminophen. While generally considered safe when taken as recommended, relatively small overdoses have been shown to cause liver damage and even death. Each year, the drug accounts for about 150 accidental deaths, half of all cases of acute liver failure cases and tens of thousands of emergency room and hospital visits, according to federal data and scientific studies.
As far back as 1977, a panel of outside experts convened by the FDA recommended the agency set the standard dose of over-the-counter acetaminophen at 325 milligrams per pill, citing the possibility of liver damage. But the agency allowed 500 milligrams and even 650 milligrams single doses of the drug for sale. Today, the most commonly sold form of over-the-counter acetaminophen contains 500 milligrams in a single pill.
A 2008 FDA review found that the agency’s approval for such a dose was based on “few and limited” studies submitted in the 1970s by McNeil Consumer Healthcare, the Johnson and Johnson unit that makes Tylenol. Two studies showed that two 500-milligram pills were “marginally” more effective than two 325-milligram pills, while two other studies showed no difference.
Ninfa Redmond, a toxicologist who helped carry out the 1977 panel’s exhaustive, three-year study, said she was surprised that such big doses continued to be sold 40 years later.
“It never occurred to any of us that you make a product with that high a dose,” Redmond said. “I use the drug when I travel, but I use 325 milligrams,” she added.
Tuesday’s recommendation only applies to prescription drugs, not the over-the-counter products that make up about 80 percent of the market, according to the FDA. That means that you will still be able to walk into a gas station or grocery store and buy pills with up to 650 milligrams of acetaminophen, while your pharmacist is now discouraged from dispensing any product with more than half that amount.
One reason for this is that the FDA has more power to regulate prescription drugs than over-the-counter medicines.
In June 2009, an FDA advisory panel urged various limits on both over-the-counter and prescription drugs. But over-the-counter drug makers, led by McNeil, resisted efforts to reduce pill strength. In a 2009 letter to the FDA, McNeil noted that 500-milligram pills accounted for 92 percent of U.S. acetaminophen sales. McNeil suggested that removing the pills from the market would “burden” consumers by blocking access to pain relief.
The company also noted that reducing pill strength would require a “significant amount of time” in the over-the-counter regulatory system. If the agency decided not to pursue such a reduction, McNeil pledged it would add language to their drug labels recommending a lower total daily limit of 3,000 milligrams – or six extra strength pills.
“Other proposals could take significantly longer to implement,” wrote Lynn Pawelski, the company’s vice president for regulatory affairs.
In 2011 the company changed its label on Extra Strength Tylenol to reflect the lower recommended maximum daily dose.
McNeil, in an emailed statement, said the company still opposes any reduction in pill size for Extra Strength Tylenol and is committed to the health and safety of its patients.
“As the makers of Tylenol ... the health and safety of consumers is our number one priority,” the statement said. “Our position was on OTC medicines and that position has not changed.”
Even with prescription drugs containing acetaminophen, the FDA has moved slowly. In 2011, the agency warned manufacturers to stop making prescription pills with more than 325 milligrams by January 2014. In this week’s announcement, the agency said more than half of all drug makers had complied with the three-year deadline, but acknowledged that some continued to sell prescription combinations with more than 325 milligrams of acetaminophen.
ProPublica found that many of the largest pharmaceutical companies had dropped the amount of acetaminophen in their combination products to meet the FDA target, including the popular pain killer Vicodin, by AbbVie Inc.; Percocet, by Endo Pharmaceuticals; and Tylenol with Codeine, by the prescription drug unit of Johnson and Johnson.
In response to questions, the FDA was unable to say how many companies had failed to comply, or what percentage of the market they represented. The agency said it would now start to crack down on the remaining combination pills. “If manufacturers have not voluntarily withdrawn these products from the market, the FDA will take the necessary steps to withdraw them,” Morgan Liscinsky, an FDA spokesman, wrote in an e-mail.
When? “In the near future,” the agency announcement said.
Gruh Finance’s net profit stood at Rs35.24 crore as its revenues increased 31% during the December quarter
Gruh Finance, a subsidiary of Housing Development Finance Corporation (HDFC), reported 22% higher net profit to Rs35.24 crore in third quarter from Rs28.89 crore same period last year.
During the quarter to end-December, Gruh Finance said its revenues grew 31% to Rs217.39 crore from Rs166.42 crore a year ago.
For the third quarter of the 2014 fiscal, the company’s total loan disbursements increased 22% to Rs1,824.74 crore from Rs1,490.71 crore same period a year ago. Gruh Finance December quarter total loan assets increased 31% to Rs6,544.60 crore compared with Rs4995.11 crore a year ago period.
Gruh Finance gross non-performing assets (GNPA) stood at Rs29.93 crore, or 0.46% of its loan assets, compared to last year’s 0.54%.
Gruh Finance closed Thursday 1% down at Rs270.45 on the BSE, while the 30-share benchmark closed marginally down at 21,265.
Despite poor local economic conditions, growth in Europe and North America led growth in TCS net profit. As per Moneylife analysis, the company’s net revenues and operating profits were above average, but dollar income was poor
Tata Consultancy Services (TCS) reported a 50.3% increase in its net profit at Rs5,333 crore for the third quarter ended December 2013. For the same period, TCS gross revenues grew 32.5% to Rs21,294 crore when compared to Rs16,070 crore for the corresponding quarter last year. However, TCS international revenues disappointed, growing just 3.8% in dollar terms. Volumes were up marginally at 1.8% while realisation was up just 74 basis points. Yet, TCS operating margin stood at 29.8%.
According to Moneylife analysis, TCS net revenues grew at 35% for the December 2013 quarter, which is higher than its three-quarter year-on-year average growth rate of 32%. Its operating profit growth rate was equally impressive as well, growing at 57% to Rs5,779.19 crore, which is higher than its three-quarter year-on-year average growth rate of 46%. The string of good performances during the FY14 so far meant its market capitalisation is valued higher at 19.95 times its operating profit. Similarly, its return on net worth stood at 51%.
Growth in Q3 was driven by industries like life sciences & healthcare, manufacturing, media, travel & hospitality, and telecom. Amongst the verticals, Business Process Services, Enterprise Solutions and Global Consulting were leaders.
TCS’s broad-based presence across markets and services helped overcome seasonal weakness in some markets. Europe led growth, driven by continuous investments being made in the market, while North America and UK also grew during the quarter. Among growth markets, Latin America, APAC and MEA registered strong growth. Indian business suffered from volatility and declined sequentially.
Commenting on the Q3 performance, chief executive officer and managing director, N Chandrasekaran said, “Strong international demand for our services and discipline in execution has helped TCS maintain its momentum and post robust growth in volumes as well as realisation. Our diversified market presence and services portfolio have helped us overcome seasonal weakness and soft demand in the Indian market.”
TCS total headcount stood at 2.90 lakh with hiring target for FY14 increased by 5,000 to 55,000. Speaking about the company’s hiring initiatives, Aloy Mukherjee, executive vice president and global head, human resources, said, “Our efforts to push the utilisation lever is paying dividends, with utilisation rates including trainees rising to 77.5% and that excluding trainees at over 84%.”
TCS attrition level at pegged at 10.9% when compared to the IT industry average of 10.3%.
During the quarter, the company snagged two $50+ million clients and four $20+ million clients.
Other key highlights were:
TCS closed Thursday flat at Rs2,351 on the BSE, while the benchmark Sensex too ended the day flat at 21,265.