HealthExecNews » FDA

Statins to get new warning labels about diabetes risk

Carol Katarsky — Tue, 06 Mar 2012 10:00:05 +0000

Several popular cholesterol-lowering drugs are about to get updated warning labels that may scare off some patients.

A number of widely used statins, including Lipitor, Crestor and Zocor are getting new warning labels courtesy of the FDA. The new labels will warn that the drugs may increase blood sugar levels and could cause memory loss.

Statins are a go-to drug for patients at risk of coronary disease — and still worth taking for the majority of those patients, according to most doctors — and the FDA isn’t recommending that fewer patients take the drugs.

But the new labels will highlight that the drugs also come with significant side effects and risks that patients need to be aware of.

The new warnings come about based on more recent research that shows patients on statins face a slightly elevated risk of increased blood sugar as well as developing Type 2 diabetes. In addition, adverse event reports indicate some patients experience memory loss while on statins. There isn’t yet any proof that statins are the cause of the problem, but the FDA wanted to alert patients to the possibility.

One warning is actually being eased though: The suggestion that patients receive ongoing monitoring of liver enzymes is being dropped since related liver disease has been found to be rare.

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Should FDA have looked into TSA’s use of back-scatter devices?

Carol Katarsky — Mon, 21 Nov 2011 10:00:17 +0000

A recent report indicates that the feds implemented controversial back-scatter X-rays throughout airports despite legitimate safety concerns from experts on radiation and public health issues.

The report, a joint effort of ProPublica and PBS NewsHour notes that the machines were approved and deemed “safe” by the Transportation Security Administration (TSA), which is solely concerned with security, instead of an agency such as the FDA, which has a focus on medical issues and public health. Because the machines aren’t medical devices, they aren’t subject to the more intense regulation that exist for similar diagnostic machines and devices.

It’s not a small issue: The scanners are expected to be in use in every U.S. airport by 2014.

The investigation by ProPublica and PBS found that radiation experts are still worried about the actual cancer risk travelers would face from repeated scans by the devices. For instance, a radiologist at University of San Francisco said that over the lifetime of a year’s worth of airline passengers, the emissions from the machines would likely cause six cancers.

Given current rates of cancer in the U.S., that’s not a significant risk, but it’s still a risk taken on with little to no benefit for the traveler. As a rule, medical professionals don’t subject patients to radiation unless there’s a clear medical benefit, such as viewing a potentially cancerous tumor, or targeting treatment. In line at the airport, there is no such benefit, and many experts — and members of the general public — are skeptical that the perceived security benefit is enough to justify even a minimal increase in the risk of developing cancer.

In the wake of the report, TSA Administrator John Pistole initially agreed to a request from the Senate to have a new independent study of the devices’ safety conducted — but he has since told the Senate that he received a new draft report that makes such a study unnecessary.

According to ProPublica, a summary of the draft report focus on the maintenance and monitoring of the back-scatter machines.

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Obama takes action on growing drug shortage crisis

Carol Katarsky — Thu, 03 Nov 2011 10:00:14 +0000

The nationwide shortage of key medications is finally getting some attention from the White House. President Obama just issued an executive order intended to eventually end the shortages of vital medications used to treat cancer and other life-threatening illnesses.

The order instructs the FDA to increase reporting of potential shortages, fast-track the review of applications to start or change production of shortage-related drugs and give information about potential price gouging or collusion to the Justice Department.

So far a record number of drugs — nearly 200 of them — have been declared in an official shortage. Prices have skyrocketed and some hospitals have reported instances of drug scalping and being offered goods that a ppeared to have been stolen and/or dangerously mishandled by third-party vendors.

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New pill design could keep generics out of reach longer

Carol Katarsky — Mon, 10 Oct 2011 10:00:48 +0000

Something as simple as adding a score mark to a pill could be enough to keep competition from generic pill manufacturers at bay. At least that appears to be the hope of pharmaceutical manufacturer Warner Chilcott. The company has added score marks to Doryx, it’s acne medication. In a filing with the FDA, the company said the scores allow users to break the tablet into thirds to better match how some patients use the medication.

The company hasn’t made any changes at all to the actual chemical composition of the pill. But if the FDA agrees this is a significant change, generic drug manufacturers would have to postpone their own releases of the drug until they’ve undergone similar makeovers.

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The scary truth about two common drugs

Carol Katarsky — Thu, 16 Jun 2011 10:00:52 +0000

A potentially dangerous side effect of two commonly prescribed drugs was just uncovered — and the way it was found is just as interesting as the actual side effect.

Researchers at Stanford University crunched data from a huge FDA side effects database, looking for evidence of diabetes-related drug interactions. They found that two drugs commonly used to treat depression and high cholesterol appear to make a dangerous combination.

According to the report, taking Paxil (paroxetine) and Pravachol (pravastin) can dangerously increase some patients’ blood sugar, sending borderline patients into a diabetic state or making existing cases of the disease harder to control. Researchers estimate more than 700,000 people take both drugs.

The finding was completely unexpected. The researchers said it showed the value of having access to large numbers of electronic health records so they can essentially study large populations in real time.

The study was published in Clinical Pharmacology & Therapeutics.

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Key drug to prevent preemies to increase from $20/shot to $1,500

Carol Katarsky — Tue, 15 Mar 2011 10:00:53 +0000

The FDA approved a commercial version of a progesterone shot used by women at risk for pre-term birth — but the approval actually makes the drug much harder to get for most patients.

Because there had been no commercial version of the drug, most patients got it made to order from compounding pharmacies. Those companies generally charged about $10 to $20 for each once-a-week dose.

But the FDA has approved a prescription version of the medication, called Makena, made by K-V Pharmaceutical. The company said it plans to charge about $1,500 per dose — but will create a patient assistance plan to ensure that those who need the drug can get it.

K-V will likely be the only provider of the drug. The company has already sent letters to compounding pharmacies warning them of FDA action if they continue to distribute their versions of the drug.

Doctors are roundly condemning the move, claiming that it will drive up insurance costs and bleed more money from already cash-strapped Medicaid programs.

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Feds to take over 3 Tylenol plants

Carol Katarsky — Fri, 11 Mar 2011 10:00:50 +0000

After a series of drug recalls and a criminal investigation, the FDA is taking over three manufacturing plants for the popular medication.

The plants, located in Las Piedras, Puerto Rico, Fort Washington, Pennsylvania and Lancaster, Pennsylvania, are run by McNeil Consumer Healthcare, a division of Johnson & Johnson.

Under a consent agreement, McNeil has agreed to put the plants under the FDA’s supervision and meet deadlines for bringing the plants back into compliance with federal safety guidelines. The company also has to hire an independent inspector to certify that the plants have corrected all violations and other issues.

If McNeil violates the agreement, the FDA can order manufacturing at the plants to halt, recall products and levy fines up to $15,000 for each day and an additional $15,000 for each violation of the law — up to $10 million annually.

The plants have had a series of quality problems in the recent past, and questions have been raised over how the company has handled the issue.

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FDA orders 500 medications off the market pending further review

Carol Katarsky — Tue, 08 Mar 2011 10:00:34 +0000

Roughly 500 prescription drugs have been ordered off the market by the FDA, which claims that the medications never had a proper federal review for safety and effectiveness. The medications are primarily used to treat allergies, coughs and colds. An agency director said the FDA had questions about what was in the medications, how they were produced and whether or not they were proven effective.

The FDA says patients still have access to many other prescription medications to treat those ailments, and shouldn’t face any problems due to the order. Over-the-counter medications are not affected by the order.

The order is part of an ongoing effort by the FDA to remove unapproved medications from the health care market. Most of the medications in question have been on the market since before a 1962 law that required a specific agency review for safety and effectiveness.

Critics of the FDA’s move, especially pharmaceutical makers, point out that the medications have been available for decades with no evidence that they pose any particular safety threat. Some critics also worry that the removal of so many medications will lead to higher overall prices for patients who rely on the drugs on a regular basis.

Manufactures of drugs on the list have 90 days to stop production and 180 days to stop distribution. They can seek FDA approval to get the drugs back on the shelves.

Check here for more details on the FDA action and the specific medications that fall under the order.

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How far can you trust your pharma-rep doc?

Carol Katarsky — Tue, 09 Nov 2010 10:00:26 +0000

A new investigation shows that doctors drug companies hire as speakers and advisers aren’t always the best and the brightest in their fields. Some of them are outright criminals. .

ProPublica recently created a database of the payments made to doctors by seven major drug companies: AstraZeneca, Cephalon, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Merck & Co. and Pfizer. The database includes just under $258 million in payments made since 2009 to doctors, based on disclosures made by the companies themselves. The payments are generally fees for speaking engagements, as well as advisory and consulting work.

ProPublica then did a review of the highest-paid physicians’ licensing records in their states. While not a complete review of the speakers, it did turn up some disturbing information.

According to ProPublica, more than 250 physician-speakers had professional sanctions against them for infractions including having sex with patients, poor patient care and improperly prescribing medication.

More than 40 had official FDA warnings for research misconduct, had lost hospital privileges and/or been convicted of crimes. Another 20 had two or more malpractice judgments or settlements against them. (Note: Some states don’t make this information publicly available, so the actual numbers of speakers who have such blemishes in their records may be higher.)

Who’s vetting the docs?

Five of the companies admitted to ProPublica that they don’t routinely check state board records for doctors they’ve hired or are considering hiring. They check the federal database and count on doctors to self-report additional information. The two companies that do check: Cephalon and Johnson & Johnson.

These doctors aren’t accused of minor paperwork slip-ups — the ethical violations put their objectivity and expertise in real doubt: In one case, the FDA ordered a doctor to stop his “false or misleading” promotions of a painkiller, citing him for downplaying its risks and encouraging its use for unapproved treatments. Since then, three pharmaceutical companies have paid him at least a quarter of a million dollars to give speeches to other doctors for their medications.

Another doctor was found by the Ohio medical board to have performed unnecessary nerve tests on 20 patients, including injecting them with chemicals that destroyed nerve tissue. He’s been paid $85k in the past two years as a speaker and adviser to drug companies.

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Are those common drugs still safe 20 years later?

Carol Katarsky — Tue, 19 Oct 2010 10:00:30 +0000

Drugs approved for chronic conditions can have major side effects that aren’t discovered until years or decades after they’re approved. Is there a better way to protect patients?

Two recent incidents involving commonly prescribed drugs have health professionals asking if there’s a better way to monitor complications, side effects and adverse reactions that may not be identifiable until after years of use.

The questions have new relevance after the diabetes drug, Avandia, was found to increase heart risks in patients; and bisphosphonates used to prevent bone fractures in patients with osteoporosis were found to increase the risk of one type of fracture as well as jaw bone degeneration.

Both types of drugs were evaluated and cleared by the FDA with no indication of these problems. Many experts say the problem is that premarket evaluation looks at relatively short-term studies — but our aging population is taking more medications for chronic diseases.

Put simply: There’s no efficient way to test the risks a drug may pose when it’s taken for decades.

A better system?

Health care professionals face a dilemma when it comes to testing drugs that patients may be on for life: Clinical trials typically last only a few years. Extending them would be difficult, costly and would deny patients faster access to drugs they need.

Some experts have recommended continuing clinical trials after a drug gets approved for the market. But that requires prescribing physicians to agree to randomly assign patients to one treatment vs. another. And the length of time required for the study would make it harder to track those patients’ results.

Another option that’s been suggested is creating a national electronic database that would make it easier to track complications from prescriptions.

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