Some Medicines and Driving Don’t Mix

Hi, Welcome to FWQRC News Letter

Here we are going to review on medicines that might affect driving

Although most medications won’t affect your ability to drive, some prescription and nonprescription medicines can have side effects and cause reactions that may make it unsafe to drive, including:

• sleepiness/drowsiness
• blurred vision
• dizziness
• slowed movement
• fainting
• inability to focus or pay attention
• nausea
• excitability

Additionally, we know that CBD can cause sleepiness, sedation and lethargy, based on data from the approved prescription CBD drug. Because of these side effects, consumers should use caution if planning on operating a motor vehicle after consuming any CBD products.

Medicines That Might Affect Driving

Knowing how your medications — or any combination of them — affect your ability to drive is a safety measure. Some drugs that could make it dangerous to drive include:

• opioid pain relievers
• prescription drugs for anxiety (for example, benzodiazepines)
• anti-seizure drugs (antiepileptic drugs)
• antipsychotic drugs
• some antidepressants
• products containing codeine
• some cold remedies and allergy products, such as antihistamines (both prescription and OTC)
• sleeping pills
• muscle relaxants
• medicines that treat or control symptoms of diarrhea
• medicines that treat or prevent symptoms of motion sickness
• diet pills, “stay awake” drugs, and other medications with stimulants (e.g., caffeine, ephedrine, pseudoephedrine)
• Taking Cannabidiol (CBD) Products and Driving Can Be Dangerous

Last year the agency approved a prescription CBD drug, Epidiolex, for the treatment of two rare and life-threatening seizure disorders in children. The FDA has not approved any other CBD products. Unlike drug products approved by the FDA, unapproved CBD drug products have not been subject to any FDA review. 

Moreover, there has been no FDA evaluation regarding whether unapproved CBD drug products are safe and effective to treat a particular disease or condition, what the proper dosage is, how they could interact with other drugs, foods or cosmetics, or whether they have dangerous side effects or other safety concerns.

But we do know that CBD can cause sleepiness, sedation and lethargy, based on data from the approved prescription drug. Because of these side effects, consumers should use caution if planning on operating a motor vehicle after consuming any CBD products.

We urge you to obtain more information about CBD by visiting: What You Need to Know About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.

Some Sleep Medicines Can Impair You, Even the Next Morning

People with insomnia have trouble falling or staying asleep. Many take medicines to help sleep. Come morning, though, some sleep medicines could make you less able to perform activities for which you must be fully alert, including driving.

A common ingredient in a widely prescribed sleep medication is zolpidem, which belongs to a class of medications called sedative-hypnotics. The FDA has found that medicines containing zolpidem, especially extended release forms, can impair driving ability and other activities the next morning.

Zolpidem immediate and extended-release forms are marketed as generic drugs and under these brand names:

• Ambien and Ambien CR (oral tablet)
• Edluar (tablet placed under the tongue)
• Intermezzo (tablet placed under the tongue)
• Zolpimist (oral spray)

People who take sleep medicines should talk to their health care professional about ways to take the lowest effective dose. Don’t assume that non-prescription sleep medicines are necessarily safer alternatives. The FDA is also evaluating the risk of next-day impairment with other insomnia drugs, both prescription and OTC versions.

Allergy Medicines Can Affect Your Ability to Drive

For allergy sufferers, medications containing antihistamines can help relieve many different types of allergies, including hay fever. But these medicines may interfere with driving and operating heavy machinery (including driving a car).External Link Disclaimer Antihistamines can slow your reaction time, make it hard to focus or think clearly, and may cause mild confusion even if you don’t feel drowsy.

Read the OTC Drug Facts label of your medicine and understand the warnings before using it. Also, avoid drinking alcohol or taking sleep medications while using some antihistamines. Those combinations can increase the sedative effects of antihistamines.

How to Avoid Driving Impaired

You can still drive safely while taking most medications. Talk to your health care provider about possible side effects. For example, some antihistamines and sleep medications work for longer periods than others. You might feel the sedating effects of these medications for some time after you’ve taken them, and maybe even into the next day.

Doctors and pharmacists can tell you about known side effects of medications, including those that interfere with driving. You can also request printed information about the side effects of any new medicine.

To manage or minimize side effects while driving, your health care provider may be able to adjust your dose, adjust the timing of when you take the medicine, or change the medicine to one that causes fewer side effects for you.

Here are some more tips:

• Always follow directions for use and read warnings on medication packaging, or handouts provided by the pharmacy.
• Don’t stop using your medicine unless your prescriber tells you to.
• Tell your health care provider about all the products you are taking, including prescription, OTC, and herbal products. Also, let them know about any reactions you experience.

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FDA Finalizes Rule to Go From Paper to Electronic Devices Submissions

Hi, Welcome to FWQRC Regulatory Focus News Letter.

Here we are going to discuss about the finalised rule for the submission process.

As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the agency on Friday issued a final rule to remove the requirements for multiple paper copy submissions and replace them with a single electronic submission.

The agency said the rule, proposed in September 2018 and will take effect in 30 days, is in response to an executive order from the Trump Administration in 2017 made famous as the “one-in, two-out” order. FDA’s rule is meant to improve the device premarket submission program and create a more efficient submission system.

“The requirement for a single submission in electronic format applies to all submission types that fall within the provisions listed in section 745A(b) of the FD&C Act; under this final rule, FDA is only amending those regulations that specifically mention paper and/or multiple copies of such regulatory submissions and are not consistent with this final rule,” FDA said.

The agency responded to four comments on the proposal but did not update the rulemaking. The agency noted that the final rule will produce cost savings for firms without imposing any additional regulatory burdens for submissions or affect the agency’s ability to review submissions.

“Firms will incur minimal administrative costs to read and understand the rule. We expect the economic impact of this regulation to be a total net costs savings yielding positive net benefits,” FDA said.

The agency also noted that submissions in electronic format can include those created and submitted on CD, DVD or flash drive and mailed to FDA.

For premarket approval applications (PMAs), the final rule changes one section to take out a section requiring an applicant to submit three copies of any updated safety and effectiveness report for pending applications.

FDA also previously required that PMAs be submitted in six copies, each bound in one or more numbered volumes, but that language has been removed with this final rule.

In another section, FDA removes the requirement that a PMA applicant has to provide copies of information that it believes to be trade secret or confidential commercial or financial information in the PMA.

FDA in September also published a draft guidance with “both binding and nonbinding provisions”

Please contact FWQRC for electronic submissions. (+91 8072483812)