The FDA’s approval in 2010 of the blood-thinner dabigatran (Pradaxa) got many doctors excited. It was at least as effective as warfarin for preventing stroke-causing blood clots, and possibly caused fewer bleeding side effects. In addition, it is easier to use. Since then, studies of Pradaxa have slightly dampened the enthusiasm for the new drug. For example, a new study from the University of Pittsburgh showed that Pradaxa cause more episodes of serious bleeding (9%) than warfarin (6%). The bleeding sites tended to differ. Bleeding in the stomach and intestines was slightly higher among Pradaxa users. Bleeding in the head was slightly higher among warfarin users. Black patients and those with chronic kidney disease were more likely to bleed from Pradaxa.
Drugs and Supplements
For the third time in two years, the FDA has approved a drug to help people lose weight. The new drug, Contrave, combines two generic drugs, naltrexone and bupropion. Naltrexone is used to help kick an addiction to alcohol or narcotics. Bupropion is used to treat depression and seasonal affective disorder. Many people also take bupropion to stop smoking. Neither naltrexone nor bupropion by itself has been approved for weight loss. Specifically, Contrave was approved for use by adults who are obese (meaning a body-mass index of 30 or higher) and by overweight adults (body-mass index between 27 and 30) who have at least one other weight-related condition or illness, such as high blood pressure or type 2 diabetes. Across the clinical trials on which the FDA based its approval, some people lost more than 5% of their body weight. But it’s important to note that more than 50% had minimal or no weight loss. Side effects ranging from seizures and high blood pressure to diarrhea and constipation were reported.
Drugs in the benzodiazepine family have long been used to treat anxiety and sleep problems. They can cause a bit of a brain hangover the next day. Experts have long assumed that people’s heads would clear once they stopped taking the drug. That may not be the case. In a study published last night by the journal BMJ, a team of researchers from France and Canada linked benzodiazepine use to an increased risk of being diagnosed with Alzheimer’s disease. In the study, the greater a person’s cumulative dose of benzodiazepines, the higher his or her risk of Alzheimer’s. Taking a benzodiazepine for less than three months had no effect on Alzheimer’s risk. Taking the drug for three to six months raised the risk of developing Alzheimer’s by 32%, and taking it for more than six months boosted the risk by 84%. People taking a long-acting benzodiazepine were at greater risk than those on a short-acting one.
When back pain strikes, all you want is relief—as quickly as possible. Many folks turn to over-the-counter pain relievers to help take the edge off and keep them moving. Acetaminophen and non-steroidal anti-inflammatory drugs, or NSAIDs (ibuprofen, naproxen, aspirin), are common and reasonable choices. Australian researchers tested how well acetaminophen worked for back pain that comes on suddenly (so-called acute back pain). Not much, it turned out. Among people who took acetaminophen as needed or on a three-times-a-day schedule, it took about 17 days for the pain to go away completely. Among those who took a placebo, it took 16 days. Does this mean that you shouldn’t bother to use acetaminophen for back pain? Not necessarily. But it might be worth trying cold, heat, and light physical activity.
Breaking a smoking habit can be hard. Nicotine is so addictive that smoking, or using tobacco in other forms, may be the toughest unhealthy habit to break. But it’s possible to quit. Nicotine replacement, in the form of nicotine patches, gum, sprays, inhalers, and lozenges, can help overcome the physical addiction. Medications such as varenicline (Chantix) and bupropion (Zyban) can also help. They can help reduce the cravings for a cigarette, and may also make smoking less pleasurable. Two new studies show that adding one or both of these medications to nicotine replacement can help improve quit rates. This research doesn’t suggest that smokers take varenicline and bupropion as a first step in smoking cessation. But when nicotine replacement alone hasn’t helped, adding varenicline with or without bupropion may lead to success.
“Replacing” a hormone the body normally makes when it is running low isn’t necessarily the safest thing to do. Women and their doctors learned this with estrogen after menopause. Now the FDA is sounding a warning that testosterone therapy can cause potentially dangerous blood clots in men. Such blood clots, called deep-vein thrombosis (DVT) and pulmonary embolism kill as many as 180,000 Americans each year, more than the number of people who die from breast, prostate, colon, and skin cancers combined. The new warning is not related to the FDA’s evaluation of possible links between testosterone therapy and stroke, heart attack, and death. Experts recommend testosterone therapy for men with a low testosterone level and one or more of the “classic” symptoms. For the rest? They get a talk-with-your-doctor recommendation. The warnings highlight that taking testosterone isn’t risk free. Combined with the lack of evidence about who really benefits, it means that the decision to start testosterone therapy is an individual one. A man must weigh the potential benefits against the potential increased risks of heart attack, stroke, and blood clots. If the balance tips in favor of moving forward, then trying testosterone is reasonable thing to do.
A few years ago, the U.S. Food and Drug Administration issued warnings that children and teens who took a common kind of antidepressant might experience suicidal thoughts. The point of the warning was to make sure that parents and doctors paid closer attention to kids taking these medications. But the plan may have backfired. A national team of researchers tracked antidepressant use among 2.5 million young people between 2000 and 2010. After the FDA’s warnings in 2003 and 2004, use of commonly prescribed antidepressants fell by 30% in teenagers while suicide attempts rose by 22%. The researchers concluded that the decrease in antidepressant use, sparked by worries over suicidal thoughts, may have left many depressed young people without appropriate treatment and that may have boosted the increase in suicide attempts.
Antidepressant medications have helped millions of people cut through the dark fog of depression. Many others try these medications but stop taking them, often because of side effects such as weight gain. A new Harvard-based study, one of the largest and longest studies of the connection between antidepressant use and weight so far, shows that the amount gained is usually small, and that it differs little from one antidepressant to another. Using citalopram as a reference, because earlier studies suggested that it is “average” when it comes to weight gain, bupropion was associated with the least amount of weight gain, close to none. Two others that also appeared to have relatively less weight gain were amitriptyline and nortriptyline. At the other end of the spectrum, citalopram caused the most weight gain. Even so, the differences between the drugs was small. The results of the study were published online this week in JAMA Psychiatry.
A study published in JAMA Internal Medicine this week found that men who used the erection-enhancing drug sildenafil (Viagra) were 84% more likely to develop melanoma, the most dangerous form of skin cancer, over a period of 10 years. That finding makes for an attention-grabbing headline. But it doesn’t tell the real story—that the study found an association (not cause and effect), that this hasn’t been seen in other studies of men, and that, even if it holds true, the absolute increase is small, from 4.3 cases of melanoma for every 1,000 men who didn’t take Viagra to 8.6 of every 1,000 men who took it. The take-home message is that it’s important to worry about melanoma—which is largely caused by getting too much sun—but not yet about Viagra and melanoma.
Dietary supplements are big business, even though few of the 85,000 products on the market have proven benefits. An article in JAMA Internal Medicine highlights a bizarre case of supplement overuse: a man, worried about memory loss, was spending nearly $3,000 a month on more than 50 supplements recommended by his “anti-aging” physician, plus hundreds of dollars more on other products he chose himself. Most of the products had no proven benefit on memory, and some may have contributed to the memory loss he was so worried about. had possible negative effects on brain function. People often assume that dietary supplements are effective, because of the claims they make, and are harmless, because they are “natural.” Not so. Unlike pharmaceuticals, which undergo extensive testing to prove they’re effective and safe before they can be sold, dietary supplements can be sold with without proof of effectiveness, safety, or purity.