FDA Wants More Testing of Effects on Driving With Psychoactive Drugs
The American Pharmacists Association is reporting that the Food and Drug Administration, FDA, has released draft guidance for directing drug makers in determining if their drugs affect a person’s ability to drive.
FDA Makes Reducing Prescription Drug Related Auto Accidents a Priority
The FDA is scrutinizing drug makers more thoroughly about the effects their drugs have on driving, according to The Hill. The draft guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle, mentions that reducing motor vehicle accidents, which result from drug effects, is a public health priority and that a systematic effort is needed to in order to determine which drugs affect driving ability.
Monthly Prescribing Reference reports that objective studies of the effects on driving of prescription drugs are needed because patients may not always be able to judge their impairment.
In the guidance, the FDA is recommending that drug makers conduct driving simulations and tests and to use a tiered approach to studying drug effects on driving, according to Regulatory Affairs Professionals Society.
FDA Drug Safety Warnings for Reducing the Doses of Sleeping Aids
The FDA released a drug safety warning for drugs containing the active ingredient, zolpidem, warning that lower doses of the drug should be used in order to reduce the risk of next day impairment.
Harvard Medical School reports the FDA wants women to take half the previous dose and for men to take the lowest effective dose of zolpidem containing sleep aids, such as Ambien, Ambien CR, Edluar, and Zolpimist, in order to avoid next day drowsiness and car accidents. The New York Times reports that the FDA has for years received reports of next day drowsiness leading to car accidents linked to zolpidem use.
The FDA has also issued a safety warning for Lunesta, warning that both men and women should take lower doses and not to drive or engage in other complex tasks the next day. The warning comes after studies of Lunesta found levels of the drug remained high enough, over 11 hours after taking the drug, to impair driving, according to Healthline.
Sleeping Aids Have Dangerous Effects
The Washington Post reports that sleeping aids can cause people taking them to perform complex activities, like driving, preparing and eating food, and making phone calls, all while being asleep.
The Huffington Post reports that people sleep driving, while on sleep aids, have caused serious and deadly motor vehicle accidents and not been aware of it till they wake up the next morning.
The impairment effects of sleep aids can last even after a person has awoken in the morning, with the FDA warning that people who have taken Ambien CR should not drive at all the next day, according to an article in the journal Nature. The warning label for Ambien also warns that use can:
- Impair alertness and coordination
- Worsen depression and lead to suicidal thinking
- Cause injury because increased risk of falls
- Lead to withdrawal symptoms
The label for Lunesta warns that using Lunesta can cause:
- Impaired alertness and coordination
- Abnormal thinking
- Performance of complex behaviors while asleep
- Suicidal thoughts and worsening of depression
- Withdrawal effects
AUTOMOBILE ACCIDENT RESULT
$1.8 MillionExpenses: $20,000.00 | Attorneys Fees: $765,000.00 | Net to Client: $1 Million
AUTOMOBILE ACCIDENT RESULTS
$2 MillionExpenses: $78,475.96 | Attorneys Fees: $850,087.96 | Net to Client: $1,071,436.00
AUTOMOBILE ACCIDENT RESULT
$2.3 MillionExpenses: $200,000.00 | Attorneys Fees: $900,000.00 | Net to Client: $1.2 Million