28 posts tagged “FDA”

Supplement safety smarts

Posted 11 months ago by

It’s easy to see the temptation of taking dietary supplements. Getting vitamins, minerals and herbs or other “health foods” in pill form sounds simple. And some of the products’ claims — “Live longer!” or “Have more energy!” — may seem enticing. But even though most supplements don’t require a prescription, it’s best to check with your doctor before taking them because they may come with risks — read on to learn more.

Healthy intentions

The BBC recently highlighted the potential risks in a piece called “The food supplement that ruined my liver.” As Texas resident Jim McCants recalls, he was hitting age 50 and hoping to prevent the heart problems that his father died from, so he sought to make some lifestyle changes. These included taking a green tea supplement, which wound up damaging the Texas resident’s liver so badly that he needed a transplant. Years later, McCants still struggles with kidney disease and abdominal pain — all because of a product he thought would make him healthier.

McCants isn’t alone. More than 50% of U.S. adults take a dietary supplement, often in the form of multivitamins, calcium, folic acid or vitamin D. And supplements are nothing new. The Chinese have been using herbal medicines for thousands of years, and you can even find some of them on drugstore shelves to this day.

It is possible to have a vitamin or mineral deficiency or imbalance, and to need some types of supplements because of this or for other health reasons (like needing folic acid during pregnancy). Take supplements as recommended by your doctor or licensed healthcare provider — but be sure to discuss any questions, concerns or adverse effects.

Risky business

How can products that are seemingly healthy be potentially hazardous? A lot of supplements contain ingredients that can actually harm rather than help your body. This is especially true if you have a health condition or take prescription or over-the-counter medication. Here are some common supplement pitfalls:

  • Medication mix-ups. Vitamins B-6, C and E can make certain kinds of chemotherapy less effective. Vitamin K can prevent warfarin (a common blood thinner) from working correctly. Vitamin B-6 may also hinder how other drugs work, such as anticonvulsants and Levodopa (a Parkinson’s disease treatment). St. John’s wort can make birth control pills and antidepressants less potent. (Keep reading for resources on possible supplement/treatment interactions.)
  • Surgery hazards. If you’re scheduled for surgery, taking some supplements can make anesthetics less powerful or lead to high blood pressure or bleeding. Give your doctor a heads-up about any supplements when he or she first mentions that you’ll need an operation.
  • Pint-sized dangers. If you’re pregnant or nursing, certain supplements — as well as prescription and over-the-counter medications — can harm your baby. Be sure to check with your doctor before taking anything.
  • Age effects. Supplements are geared primarily for adults. Dosage recommendations haven’t really been created for children. And supplements may work differently in people older than age 65.

Other risky supplement behaviors include:

  • Mixing different supplements
  • Using supplements instead of drugs that your doctor prescribed
  • Overdoing it with supplements — just to name a few examples: Taking too much iron can lead to vomiting and liver damage. Excess amounts of vitamin A (hypervitaminosis A) can result in headaches and weaker bones. Too much B-6 (called B-6 toxicity) may lead to lack of muscle control (ataxia), numbness, gastrointestinal issues and other symptoms.

Less oversight

The U.S. Food and Drug Administration (FDA) doesn’t regulate dietary supplements in the same way that it does with prescription and over-the-counter medications. What a label says about a product’s effects and ingredients may not be entirely accurate. However, if it turns out that a supplement is dangerous or that the makers made false claims, the FDA can issue warnings or take it off the market.

Doctor-pharmacist tag team

Ask your physician what he or she recommends in terms of taking — or not taking — dietary supplements and what’s best for you. And tell your doctor right away about adverse effects you’ve experienced while taking a vitamin or supplement, just as you would with prescription drugs.

Another great resource is right around the corner — your local pharmacist. Make it a habit to swing by the drugstore’s pharmacy counter, even if you’re just buying an over-the-counter treatment. As a medication specialist, your pharmacist knows how drugs affect the body and will be able to help you determine if a specific product has the potential to interact with any of your prescription medications. Try to use one pharmacy for all your prescriptions so your record will be complete and easy to access.

Do your research

Besides talking with your doctor and pharmacist about dietary supplements, vitamins, minerals, herbs and over-the-counter treatments, here are some resources that may be useful:

  • Supplement specifics. For more information on individual supplements, how they work and what common dosages are, check out the handy list on MedlinePlus.
  • Drug interaction checkers. Are your medications safe to take together? Try checking one of these sites (although they’re not exhaustive, so a doctor or pharmacist is still your best resource): RxISK and Drugs.com
  • Vital vitamin and mineral info. What amount of vitamins and minerals do you need each day? Find out with this chart from the 2015–2020 Dietary Guidelines. Helpful hint: Click “Next column” or “Previous column” in the upper right to find the relevant gender and age range.
  • Medication record charts. Keep track of all your treatments (prescription and over-the-counter) and your supplements on your PatientsLikeMe profile and with this smart chart from the FDA. Give an up-to-date copy to your doctor and pharmacist at each visit.

It’s worth a little extra work up front to do your research and keep your doctor and pharmacist in the loop.

“Your local pharmacist is an excellent resource to help you decide if supplements might be right for you,” says Maria Lowe, Pharm.D., from the PatientsLikeMe Health Data Integrity Team (our group of in-house healthcare professionals). “As pharmacists, we are not only trained to be experts in drug therapy but also in various methods of self-care. It’s our job to help our patients find the optimal way to combine those treatment modalities whenever we can.”

What steps do you take (or will you take now) when it comes to supplement safety? Join PatientsLikeMe or log in to talk about this topic with others who are living with health conditions.


2 immunotherapy treatments in the news: Imfinzi and Keytruda update

Posted May 10th, 2018 by

Two immunotherapy treatments — Imfinzi (durvalumab) and Keytruda (pembrolizumab) — have made headlines recently in relation to lung cancer treatment. What’s the latest? Here’s an update.

2 immunotherapy treatments in the news: Imfinzi and Keytruda update

Expanded FDA approval for Imfinzi

The U.S. Food and Drug Administration (FDA) first approved Imfinzi as a bladder cancer treatment in 2017. Imfinzi is marketed by AstraZeneca.

In February 2018, the FDA approved Imfinzi for some lung cancer cases — specifically for patients with “stage 3 non-small cell lung cancer [NSCLC] who are not able to be treated with surgery to remove their tumor, and whose cancer has not gotten worse after they received chemotherapy along with radiation (chemoradiation),” the American Cancer Society (ACS) explains.

A few more details on Imfinzi, according to the ACS:

  • The goal of treatment with this drug is to keep the cancer from getting worse for as long as possible (researchers call this “progression-free survival”).
  • The new approval for Imfinzi was based on a randomized clinical trial of 713 people, which found that those who received the drug had an average progression-free survival of 16.8 months compared to 5.6 months for those in the trial who did not receive it.
  • Imfinzi is a “checkpoint inhibitor” drug that targets and blocks the PD-L1 protein to help the immune system recognize and attack cancer cells (learn more about PD-L1 here, and read about possible Imfinzi side effects here)

The new approval for Imfinzi applies to very specific cases of NSCLC, but Reuters says it represents “a chance to intervene earlier in lung cancer,” since other approved immunotherapy treatments are tackling advanced or metastatic cancer.

Positive research on Keytruda + chemotherapy

Keytruda is another “checkpoint inhibitor” immunotherapy treatment that’s already on the market but making big headlines, thanks to new clinical trial findings. Companies such as Hope From Within who practice immunotherapy should be able to advise patients on these checkpoint inhibitors.

Research published this month in the New England Journal of Medicine shows that Keytruda is useful in combination with standard chemotherapy in the majority of patients diagnosed with an advanced form of lung cancer — specifically those with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK gene mutations.

“Doctors already prescribe Keytruda to patients if a lab test shows that they are likely to respond to this drug,” NPR reports. “But Merck, the company that makes it, wanted to find out how the drug works in patients who aren’t obvious candidates as determined by that blood test… It turns out that Keytruda, in combination with standard chemotherapy, also works in patients even if they have a low score on the lab test, which measures something called the tumor proportion score for PD-L1.”

The phase 2 clinical trial involved 616 patients with advanced lung cancer from medical centers in 16 countries (check out this PatientsLikeMe guide to clinical trials and drug approvals).

“The findings, medical experts say, should change the way doctors treat lung cancer: Patients with this form of the disease should receive immunotherapy as early as possible,” The New York Times reports, along with more details on the research.

Check out PatientsLikeMe member’s treatment evaluations of Keytruda (pembrolizumab) here (become a member for access to more information). And see our previous round-up on lung cancer research and treatments (with many studies still ongoing).

Full disclosure: PatientsLikeMe is currently partnering with AstraZeneca on research projects. We’ve also partnered with Merck in the past. The article above is not sponsored – this topic has made headlines lately and we like to share relevant health news to help keep our communities informed. Questions about our partnerships? At PatientsLikeMe, we’re all about transparency so check out who we’ve worked with here.

Looking for more information on patients’ experiences and treatments for lung cancer? Join PatientsLikeMe today to connect with 9,000+ members with lung cancer.

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