Adverse Effects from Personal Care Products Climb 300% in 2016

Reports of side effects caused by cosmetics and personal care products sold in the U.S. more than doubled in 2016, and that’s partly due to complaints about WEN by Chaz Dean Cleansing conditioners, according to recent study. [1]

Researchers looked at data on side effects reported to the U.S. Food and Drug Administration (FDA) from 2004-2016 for products including makeup, sunscreen, tattoos, hair color, perfume, shaving creams, and baby care items. A total of 5,144 adverse events were reported to the agency during that time, with an average of 396 a year, the team writes in JAMA Internal Medicine.

Source: Campaign for Safe Cosmetics

Side effect reports skyrocketed from 78 to 706 in 2015, and there was a huge 300% spike to 1,591 adverse events in 2016, due in large part to complaints concerning WEN products.

In 2014, the FDA announced it was investigating WEN by Chaz Dean Cleansing Conditioners after receiving reports that the products cause hair loss, hair breakage, balding, itching, and rash. The agency had received 1,386 complaints as of November 2016. [2]

Read: 5 Toxic Ingredients Probably Found in Your Shampoo

Through that investigation, the health regulator discovered that Chaz Dean Inc. and parent company Guthy Renker LLC had been buried in more than 21,000 complaints. It didn’t matter, though; companies are not currently required by law to report complaints.

The FDA doesn’t regulate cosmetic products, and companies can launch products without the agency’s approval.

In an e-mail, the FDA said:

“The law does not require cosmetic companies to share their safety information, including consumer complaints, with the FDA. FDA’s data on cosmetic adverse events are limited because reporting is voluntary. The FDA may take regulatory action against cosmetics on the market that do not comply with the laws we enforce, if we have reliable information indicating that a cosmetic is adulterated or misbranded.”

If you wind up losing clumps of hair after using a particular product, complaining to the manufacturer may or may not get you results.

Read: 4 Solutions for Naturally Healthy Skin from the Inside-Out

Dr. Shuai Xu, a dermatology researcher at Northwestern University Feinberg School of Medicine in Chicago, said:

“Adverse events to cosmetics matter to patients mostly because nearly everyone uses a cosmetic or personal care product every single day – this includes newborns, infants and pregnant women. Unlike drugs and medical devices, cosmetics permeate daily life. We’re exposed to hundreds of chemicals a day from these products.”

Source: Campaign for Safe Cosmetics

And, he said, there are likely far more adverse events caused by cosmetics and personal care products than is represented by the findings.

“These numbers are likely underreported. We need better reporting, from both consumers and clinicians. Broadly, the hope of our paper was to continue this discussion to modernize and expand the collection of data about personal care products. If you can’t measure it, you can’t manage it, was our key point.”

Xu says most cosmetic and personal care products are safe, but it’s hard proving that the “bad” ones are truly unsafe.

“When it comes to cosmetics on the shelves that are dangerous, it’s very hard to prove. In general, cosmetics are a very safe product class.”

The Personal Care Products Council (PCPC) said in a statement that it “believes that mandatory adverse event reporting is critically important, which is why we have long advocated for it on Capitol Hill.”

PCPC adds:

“Nevertheless, despite the recent increase in reporting, the fact remains that only a very small percentage of cosmetics products on the market are associated with adverse events. And of those, a fraction are listed as ‘serious.’

“In other words, even with the increase, adverse reactions associated with cosmetics and personal care products are extremely rare.”

But if the numbers are inaccurate, how can we really know?

Sources:

[1] Reuters

[2] CNN

Campaign for Safe Cosmetics

Campaign for Safe Cosmetics


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Study: Safety Issues Plagued 1/3 of FDA-Approved Drugs from 2001-2010

The U.S. Food and Drug Administration (FDA) is tasked with making sure that drugs and medical devices are safe and efficient for Americans to use. However, it appears that the agency doesn’t take its job seriously enough, because a new study shows that nearly 1/3 of medications approved from 2001 to 2010 had safety issues years after they were made widely available to patients, and some were quite serious. [1]

The study, published May 9 in JAMAshows that 71 of the 222 drugs approved during that time period were withdrawn, required a “black box” due to their side effects, or warranted a safety announcement about new risks.

Source: Center for American Progress

Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, says:

“While the [Trump] administration pushes for less regulation and faster approvals, those decisions have consequences.”

A 2015 independent analysis of drugs approved using the agency’s expedited approval process found that the trend of speeding approval “is being driven by drugs that are not first in class and thus potentially are less innovative.” [2]

But President Trump isn’t the first president to pressure the FDA to speed up its drug approvals.

On December 13, 2016, President Barack Obama signed the 21st Century Cures Act. The law provides speedier routes to approval by pushing the FDA to consider evidence beyond the normal 3 phases of clinical trials. The move upset many researchers who feared the law would allow the approval of drugs that haven’t been adequately studied.

Says Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University, who wasn’t involved in the study:

“I’m actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job. The one place you don’t want to cut a corner is safety and efficacy prior to coming to market.”

According to the study, during the first decade of the millennium, the FDA approved drugs faster than the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA), the majority of clinical trials in drug approvals involved fewer than 1,000 participants, and lasted 6 months or less, according to the findings. [1]

On average, it took 4 years and 2 months after the drugs were approved for safety issues to emerge. The most troublesome drugs included psychiatric medications, biologic drugs, drugs granted “accelerated approval,” and drugs that gained approval at the tail end of the regulatory period.

But drugs that were granted accelerated approval had the worst track record. Dr. Nicholas S. Downing, an author of the study and a resident physician of internal medicine at Brigham and Women’s Hospital in Boston, says:

“The key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug.

Downing says that scientists need to continuously test drugs to make sure they work with a wide range of variables, and used aspirin as an example. The medication has been used for hundreds of years, yet “there are still countless new studies coming out, and we learn more about it all the time.” [2]

Sources:

[1] Kaiser Health News

[2] CNN

Center for American Progress


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Study: Cannabidiol-Based Medication Reduces Intense Seizures by 50%

Marijuana has been associated with reducing seizures in people with epilepsy for years, but only now is the topic getting more of the scientific scrutiny it deserves. In a recent study, cannabidiol (CBD) reduced the number of seizures by half in a substantial number of children and adults with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy.

GW Pharmaceuticals, a developer of cannabidiol, sponsored the study.

In a press release, study author Dr. Anup Patel, of Nationwide Children’s Hospital and The Ohio State University College of Medicine in Columbus and a member of the American Academy of Neurology, said:

“Our study found that cannabidiol shows great promise in that it may reduce seizures that are otherwise difficult to control. This is important because this kind of epilepsy is incredibly difficult to treat.”

Tracking the Effect of CBD on Seizures

For the study, researchers followed 225 people with LGS for 14 weeks. The participants had an average age of 16 and experienced an average of 85 “drop seizures” (also called atonic seizures) a month.

Read: Cannabis Compounds Reduce Serious Seizures in Children by 53%

These types of seizures result in a loss of muscle tone, causing the person’s head or body to suddenly go limp. Though atonic seizures generally last less than 15 seconds, the loss of muscle tone causes the person to fall to the ground, and they may need to wear a helmet or other form of head protection. [2]

LGS usually first affects patients beginning in childhood, have different types of seizures on a daily basis, and often have learning impairments. [3]

Source: LGS Foundation

The participants had also unsuccessfully tried an average of 6 epilepsy drugs and were taking an average of 3 epilepsy drugs during the study.

  • One group of participants was given 20 mg per kilogram (mg/kg) of cannabidiol daily.
  • A second group received just 10 mg/kg.
  • A third group received a placebo.

On average, the group that took the lower dose of cannabidiol had a 37% decrease in seizures. The participants who took 20 mg/kg saw their seizures decrease by half or more.

The placebo group also saw a decrease – about 17%. About 15% had their seizures decline by half or more.

After doing the math, the researchers concluded that participants in the high-dose group were 2.6 times more likely to report their overall condition had improved compared with the those in the placebo group.

Read: Cannabis Compound Found to Help Rare Forms of Epilepsy

Some 94% of those in the high-dose group and 84% of those in the lower-dose group did experience side effects. About 72% of the placebo group said they, too, had side effects. However, the side effects – including loss of appetite and sleepiness – were mild to moderate. [1] [4]

Patel said:

“Our results suggest that cannabidiol may be effective for those with Lennox-Gastaut syndrome in treating drop seizures. This is important because this kind of epilepsy is incredibly difficult to treat. While there were more side effects for those taking cannabidiol, they were mostly well tolerated. I believe that it may become an important new treatment option for these patients.”

Next, the team plans to seek approval from the FDA to license cannabidiol LGS sometime this year.

The study findings were presented at the American Academy of Neurology’s 69th Annual Meeting in Boston.

Sources:

[1] Healthline

[2] Epilepsy Foundation

[3] Vocativ

[4] UPI

LGS Foundation


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