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Tag: FDA

  • FDA seizing some prescription drugs imported from Canada

    FDA seizing some prescription drugs imported from Canada

    Phil Galewitz reports for Kaiser Health News that the FDA recently has been seizing some drugs that Americans are importing from Canada and other countries. Given that stay-at-home orders during this pandemic make it difficult for people to get their prescription drugs from local pharmacies, it’s hard to understand what’s motivating the FDA at this time. FDA actions are particularly harming older people, who take more prescriptions than younger people and are most at risk if they get COVID-19.

    Kaiser Health News has previously reported that around nineteen million Americans import their prescription drugs from abroad. Right now, the numbers could be way up. Buying prescription drugs from abroad can save people a lot of money. And, it keeps them from having to leave their homes, which puts them at risk of getting COVID-19.

    Last month, the FDA seized one 83-year old man’s asthma drug. The FDA claimed it was not correctly labeled. The man had been getting it from Canadian MedStore at a 35 percent discount from what he would pay if he bought it at his local pharmacy. He saves hundreds of dollars a year this way.

    The FDA letter explaining the seizure of this drug also said that it had not been approved for sale or use in the US because it is a “foreign-made” drug. However, the drug’s packaging is identical to the packaging of the drug sold in the US. And, it is common for drugs sold in the US to be manufactured outside the US.

    Right now, PharmacyChecker.com verifies the legitimacy of pharmacies outside the US. Keep in mind that importing drugs for personal use is generally illegal, although the FDA typically does not stop such importation.

    Moreover, for more than 15 years now, the FDA for the most part has allowed retail stores in Florida to help people buy drugs from Canada and other countries. Recently, countries that export drugs to the US for people’s personal use have switched from selling a 90-day supply to a 30-day supply.

    The smartest and fairest way to bring down drug prices quickly is for Congress to mandate that drug corporations cannot charge Americans more for prescription drugs than the average price charged in other wealthy countries. Senator Bernie Sanders and Ro Khanna have a bill in Congress to that effect. House Speaker Nancy Pelosi has a limited version of a similar bill that has passed in the House of Representatives.

    If you believe Congress should rein in drug prices, please sign this petition.

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  • Warning: Your hip replacement could kill you

    Warning: Your hip replacement could kill you

    Jeanne Lenzer writes for the New York Times about the danger of getting a hip replacement. In some cases, your hip replacement could cause serious harm. In general, as we have reported, FDA-approved medical devices may not be safe.

    Stephen Tower, an orthopedic surgeon, had a metal-on-metal hip implanted, the ASR XL, made by Johnson & Johnson. Dr. Tower specializes in complex hip replacements, but he was not aware that the hip he chose for himself had a serious defect. He ended up needing another surgery because of the pain his artificial hip was causing him.

    Dr. Tower’s artificial hip had turned the tissue around it black. The artificial hip leaked cobalt causing Dr. Tower to suffer from metallosis. Muscles, tendons and ligaments near the hip were destroyed. Worse still, Dr. Tower suffered damage to his heart and brain.

    Afterwards, Dr. Tower warned Johnson & Johnson of the serious defect in the hip but the medical device company did nothing about it. Rather, it continued to market metal-on-metal hips. It finally withdrew the ASR XL model from the market in 2010, but it sold another metal-on-metal hip, the Pinnacle, until 2013.

    Thousands of people received a Johnson & Johnson metal-on-metal hip replacement during this time. Six of them won a $247 million verdict because of the Pinnacle’s harmful side effects and because Johnson & Johnson did not warn doctors or patients about these side effects.

    Unfortunately, these metal-on-metal hips are one of many FDA-approved medical devices on the market that put patients at risk for dangerous side effects.  A provision of the Federal Food, Drug and Cosmetic Act, known as 510(k), allows medical device companies to market many new products without having to do any clinical trials. All that the medical device company need do is claim that the device is “substantially equivalent” to a medical device already on the market.

    While the FDA can recall the product if it is deemed to cause harm, it can take a long time for that recall to happen. Hundreds of thousands of people can end with the device implanted before it is recalled. And removal of the device once recalled can also jeopardize patients’ health.

    In 2016 alone, the FDA recalled 117 medical devices because of a “reasonable probability” that they would “cause serious adverse health consequences or death.”

    Medical devices that undergo clinical trials are also not guaranteed to be risk free. Indeed, the FDA may conditionally approve them even when the clinical trials show potentially harmful side effects, including a high death rate. That’s what happened with a Cyberonics device designed to treat epilepsy. The FDA did not require that patients who received this device be told about the risk of dangerous side effects.

    The FDA’s approval process appears to put profits before patients. Yes, more devices get to market more quickly. But, at what cost to human life and health?

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  • Avoid brain-boosting supplements

    Avoid brain-boosting supplements

    Brain-boosting supplements, much like weight-loss supplements, are extremely popular. But, as all dietary supplements, they are not well regulated and they can have dangerous ingredients. Elizabeth Cooney reports for Stat News on new research out of Harvard Medical School that should give anyone thinking about taking brain-boosting supplements pause.

    Dr. Pieter Cohen studied five different brands of brain-boosting supplements. As he reported in JAMA Internal Medicine, they all contain piracetam, a drug which is not FDA-approved and cannot be sold in the US. Cochrane looked at 24 studies of piracetam and found that there was not sufficient evidence to show that it improved people’s memory, or their ability to learn or to understand.

    A standard dose of piracetam has been found to cause anxiety, agitation and depression. People who take supplements with piracetam have no way of knowing the dosage they are taking. It could be way more than the standard dose. And, it could be dangerous to their health.

    But, the FDA is doing nothing to stop its sale. Moreover, the FDA is doing nothing to warn the public about the dangers of piracetam. However, the federal government’s dietary supplement law prohibits companies from selling supplements with piracetam, because it is considered unsafe.

    The FDA has limited resources for oversight. And, it is not using those resources to monitor supplements to the extent needed. Instead it is proposing a new rule that would require dietary supplement manufacturers to notify the FDA of all their products.

    For now, you are better off eating a healthy diet and avoiding supplements.

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  • One pharmacy uncovers dangerous chemicals in some common drugs

    One pharmacy uncovers dangerous chemicals in some common drugs

    A small pharmacy based in New Haven is testing the prescription drugs it dispenses for safety. And, it is uncovering dangerous chemicals in some common drugs. Talk to your doctor about the safety of the drugs you’re taking.

    We know that some drugs the FDA has approved have turned out not to be safe. But, how many others are unsafe that have not been reported? Carolyn Johnson reports for  The Washington Post that Valisure, a small online pharmacy, is checking every drug it sells before dispensing it.

    Since it began testing the drugs it dispenses, Valisure has found a sea of drug safety issues and other prescription drug problems. It rejects more than one in ten drugs it tests because it finds either that they contain contaminants or otherwise do not perform as expected. For its part, the FDA says that drug safety is not an issue with its approved drugs.

    Valisure recently found that Zantac, a best-selling drug, is less safe than many people thought. It contains a cancer-causing chemical. Since Valisure’s discovery, 40 countries have stopped allowing it to be sold.

    The FDA has asked for the recall of Zantac and other products with ranitidine and nizatidine. Pepcid, Tagamet, Nexium, Prevacid and Prilosec don’t contain these dangerous chemicals.

    Valisure also found that rapid release Tylenol gelcaps dissolve far less quickly than the less costly Tylenol uncoated tablets. In this case, the problem was the misleading marketing of the product, not its risks. The manufacturer subsequently clarified that its marketing was suggesting only that the rapid-release gelcaps dissolved more quickly than other gelcaps, another reason not to trust the marketing hype on products.

    Quality and safety may be an issue because many drugs are manufactured abroad, with less stringent regulatory oversight than in the US. In 2016, the Government Accountability Office reported that nearly 1,000 of 3,000 foreign manufacturing sites had not been inspected by the FDA. Some believe that inspections alone are not enough to ensure safety.

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  • How should we address drug shortages?

    How should we address drug shortages?

    It’s hard to believe, but some prescription drugs are hard to come by. A new federal report by the Food and Drug Administration (FDA) attributes these drug shortages to a combination of low profitability and a “broken” health care marketplace. The FDA’s market-based recommendations for addressing these drug shortages likely means we can expect them to continue.

    These days, more than 150 prescription drugs are in short supply in the US. Both generic drugs and brand-name drugs can be hard to come by. They include anesthesia drugs such as lidocaine, palliative care drugs such as bleomycin for patients with cancer, drugs for septic shock such as norepinephrine, and vaccines. Medical supplies, such as sterile water, can also be unavailable.

    To be clear, drug shortages mean treatment delays or changes in treatment regimens for patients. This can jeopardize their health. One study found that more than half of hospitals (56 percent) reported they had delayed or changed patient treatment  because of drug shortages. 

    Unfortunately, the problem is not getting better. In fact, it’s getting worse. An increasing number of drugs are in short supply. Moreover, shortages of drugs tend to last longer and longer.

    As unfortunate, no one is keeping good data on the issue. We need good evidence of the number of drugs unavailable at any given time and the consequences of their lack of availability. As the report says, we need to know the frequency, persistence and intensity of drug shortages if we are going to best prevent them.

    Most of the 163 drugs that are hard to get are generic drugs that have been on the market for decades. But, more than 50 are brand-name drugs. The reason that about half of these drugs are so hard to get is quality-control problems where the drugs are manufactured.

    The FDA report recommends that the price of these drugs go up to address the shortages. It suggests that there be quality ratings of these drugs as a possible way to help pharmaceutical companies command higher prices for them.

    Notably, the authors did not recommend government intervention to ensure these drugs are available, even though some of these medications are critical for saving lives. Vincristine, for example, is a cancer drug, that treats a variety of common childhood cancers. Pfizer, which makes the drug, says it is addressing the shortage.

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  • Do new cancer treatments offer meaningful benefits?

    Do new cancer treatments offer meaningful benefits?

    Stat News reports on a new study, published in BMJ, which finds that around 50 percent of the clinical trials for cancer treatments approved in Europe may not demonstrate meaningful benefits. Risk of bias in the design and reporting of clinical trials may mean that the drugs lack both therapeutic and financial value. Studies of clinical trials for cancer drugs approved in the US have similar flaws.

    For the BMJ study, researchers looked at the strength of the evidence supporting new cancer drug approvals in Europe. They analyzed 54 clinical trials for the 32 cancer drugs approved between 2014 and 2016. Of those with published studies, only one in four looked at overall survival rates. All the other trials, 29 out of 39, used “surrogate measures.” Surrogate measures cannot predict whether someone will live longer or enjoy a better quality of life. Some academics say they may undermine patient safety.

    Researchers found that just about half (49 percent) of the published trials had a high risk of bias. They found a much higher risk of bias in the trials looking at surrogate measures of patient benefit (55 percent) than in the trials measuring overall survival (20 percent). Note: Researchers found risk of bias, not actual bias.

    Only 75 percent of the drug studies (41 of them) from 2014 to 2016 involved randomized, controlled trials. Just 27 of the 32 newly approved cancer drugs had a randomized trial. Between, 2009 and 2013, 90 percent of the studies involved randomized, controlled trials.

    In addition, of the 32 drugs approved, 10 had problems identified by regulators. But, somehow, the regulators’ concerns about these drugs did not make it into the scientific literature.

    The researchers recommend that clinical research for drugs be based on randomized trials and that these trials study data on meaningful outcomes, specifically overall survival. Without this research, it is hard to know whether new cancer drugs meet patients’ needs. It’s best to have a quality assessment of the evidence as well. Bias in clinical trial design is a serious issue.

    The researchers also want more transparency from regulators. Patients should know the weaknesses of the research underlying a new drug and how these weaknesses might affect the trial results.

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  • Skin care products carry big risks

    Skin care products carry big risks

    A 2017 research letter in JAMA Internal Medicine speaks to the big risks of cosmetics and other skin care products, which do not require Food and Drug Administration (FDA) pre-market approval; manufacturers are not even required to let the FDA know about reported harms. Risks include everything from non-serious injury to serious injury, disability, congenital defect or death. You can learn more about products from the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CFSAN).

    There are risks associated with lipsticks, lip ointments and mascaras. One product, WEN, by Chaz Dean Cleansing Conditioners appears to cause hair to fall out as well as scalp irritation. Although the manufacturer has received 21,000 complaints about the product, it is still on the market.

    If you’d like to avoid buying products that contain dangerous chemicals, visit the Environmental Working Group’s Skin Deep site, which rates almost 70,000 skin care products based on their chemical makeup.

    The three categories of products most reported on CFSAN were hair care, skin care and tattoos. Products with the most serious health outcomes were baby products, personal cleanliness products and hair coloring products.

    The FDA needs to oversee cosmetics and personal care products, especially because these products do not need to be approved before being sold. Requiring manufacturers of personal care products to report adverse events is critical. The CFSAN likely only captures a small portion of harms.

    California Senator Diane Feinstein has a bill in Congress, the Personal Care Products Safety Act (S.726), which would give the FDA the ability to recall unsafe cosmetics and personal care products and would also require the manufacturers to report adverse events.

    ___________________________

    This post was first published on July 4, 2017 and has been updated.

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  • What to do with unused medicines?

    What to do with unused medicines?

    Prescription drugs can be harmful, if used by people in your home who should not be taking them or if disposed of improperly. Here’s how the Centers for Disease Control (CDC) and the US Food and Drug Administration (FDA) recommend handling the prescription drugs you use, as well as unused medicines that you no longer need.

    Medicines you use: You want to make sure that you keep the  prescription drugs you take in a safe place. If there are children or grandchildren around, especially, you want to ensure that pill bottles are closed and put away out of reach. Every year, tens of thousands of children end up in the emergency room because they took medicines that were mistakenly not put away.

    Medicines you do not use: Unused and expired medicines need special attention as well. It’s best not to let them sit in the medicine cabinet. But, you should not assume you can throw them in the garbage or flush them down the toilet. They could then end up in the water supply. As it is, some chemicals are in our water supply and they may be causing harm to the environment. We want to keep our water supply as clean as possible.

    The FDA and CDC both recommend bringing your medicines to National Prescription Drug Take-Back Day on October 26, 2019. You can dispose of them at a Take-Back site. In April, the most recent take-back day, people brought in 937,443 pounds (468.72 tons) of unused or expired prescription medication.

    You may also be able to bring unused medicines to your pharmacy for disposal. Ask your pharmacist.

    If you can’t turn your prescription drugs in, check the FDA flush list. Some medicines are OK to flush down the toilet, including oxycodone, fentanyl, morphine and diazepam. The FDA recommends flushing them down the toilet if you can’t bring them to an appropriate take-back site because they otherwise can pose a serious hazard to others in your home.

    If you cannot take the drugs to an appropriate site and the drugs should not be flushed down the toilet because they can seriously contaminate the water supply in your community, the FDA recommends mixing the medicines with something unappealing such as dirt, cat litter or dirty water; then, place the mixture in a sealed container and put it in the trash. You should remove any personal information from the pill bottles.

    Here’s more from Just Care:

  • How safe are generic drugs?

    How safe are generic drugs?

    An op-ed by Katherine Eban in The New York Times exposes the FDA’s lax regulatory oversight of generic drug manufacturing. It makes a compelling case that generic drugs that are manufactured abroad may not be safe. What is to be done?

    The FDA is extremely limited in its ability to oversee foreign generic drug manufacturing plants.  Yet, 90 percent of the drugs we take are generic. We depend upon them heavily. And, many are manufactured abroad.

    Back in 2012, the FDA’s Peter Baker took on the job of inspecting Indian generic drug manufacturing plants.  He wanted to understand best practices. Instead, he saw serious safety risks. And, he discovered false data and reports at 29 of the 38 generic drug plants he visited. More recently, he found a similar rate of fraud and deception in Chinese drug manufacturing plants.

    Generic drug manufacturers must comply with FDA regulations, including collecting and storing data about drugs as they are made. But, they too often do not comply, according to Eban, who reports extensive problems in India and China. For example, at one manufacturing plant, Baker saw that an employee was trying to bury data showing that the manufacturer knowingly distributed insulin containing metallic pieces from a defective machine. And, it continued to use that machine to manufacture other drugs. Shortly after Baker’s discovery, the FDA stopped all imports from that plant.

    As Baker continued his inspections, he discovered that fraud and deception were the norm at these generic manufacturing plants. He identified secret labs and false data at nearly 80 percent of plants. The FDA was receiving completely trumped up reports from the manufacturers. Around 40 percent of generic drugs sold in the US are manufactured in India.

    Moreover, the FDA reports that  80 percent of active ingredients in all drugs sold in the US are not made in the US. And, 40 percent of finished drugs are imported. Gabriel Levitt, president of PharmacyChecker.com told me that his company found that 71 of the 100 most frequently used brand-name drugs are not made in the US. 

    Eban writes that “In some instances, deceptions and other practices have contributed to generic drugs with toxic impurities, unapproved ingredients and dangerous particulates reaching American patients.” And, she says that the generic drugs are, in some cases, making patients in the US sicker.

    Eban doesn’t highlight concerns with brand-name drugs, even though many of their active ingredients are manufactured overseas as well, including India and China. And, some brand-name drugs manufactured in the US have been found to put patients at risk. In 2010, the government fined Glaxo-Smith Kline $750 million for intentionally selling 20 contaminated drugs that may not have been safe or effective. More recently, the FDA cited Pfizer for manufacturing and selling EpiPens that did not work properly, which may have led to the death of seven people.

    Between 2013 and 2018, the FDA has lightened the punishment on generic drug manufacturing plants that cook their books or otherwise make drugs that may be unsafe. It often asks the manufacturer to take “voluntary action” to address problems and allows their drugs to be sold in the US.

    Eban calls on the federal government to ban drugs in the US that are made in plants that do not comply with FDA regulations. That seems like a fair start. Another strategy would be for the federal government to manufacture the drugs itself, something it once did in some instances.

    Here’s more from Just Care:

  • What are probiotics and should you take them?

    What are probiotics and should you take them?

    These days, it seems that everyone is recommending particular diets to improve your health. And, lots of people, including Consumer Reports, are recommending probiotics, such as dark chocolate, greek yogurt, kimchi and sauerkraut.  What are probiotics and should you take them?

    According to the National Institutes of Health, probiotics are microorganisms similar to good bacteria in our guts. It warns that the U.S. Food and Drug Administration (FDA) has not approved any health claims about the benefits of probiotics.

    There is some evidence that probiotics can benefit people with diarrhea and irritable bowel syndrome. But, there is more research needed. Benefits have not been shown conclusively, and it’s not clear which, if any, probiotics are beneficial.

    The data suggest that side effects of consuming probiotic foods and drinks are few for people who are relatively healthy. But people who are critically ill with weak immune systems or post surgery could experience severe side effects, including infections.

    The NIH warns against taking probiotic dietary supplements, marketed like vitamins as capsules or tablets, without first talking to your doctor. They are not regulated by the FDA and it’s not always clear what ingredients they contain.

    [Editor’s note: New studies reported in StatNews continue to warn against taking probiotic supplements. They also suggest probiotics may not be good for your immune system. Findings from one small study show that people taking probiotic supplements who were also getting cancer immunotherapy treatment for melanomas were far less likely to respond to the treatment. Eating more fiber appeared to help people respond to immunotherapy treatment.]

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