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Drug and Device Safety

Keep up to date with drug and device safety through FDA drug alerts and the vaccine adverse event reporting system.

The FDA has issued an alert that may impact your patients:

  • Mitoxantrone: On December 23, 2014, Hospira, Inc. announced a worldwide voluntary recall of 10 lots of MitoXantrone, due to confirmed subpotency and elevated impurity levels. Affected lots were distributed to hospitals from February 2013 through November 2014. Read the FDA MedWatch safety alert for recommendations for health care professionals
New MS Drug Peginterferon Beta-1a Approval

The Multiple Sclerosis Emerging Therapies Collaborative has published information sheets on the new multiple sclerosis (MS) drug peginterferon beta-1a (Plegridy). The Food and Drug Administration (FDA) approved this drug in August 2014 for use in relapsing-remitting MS.

Read the information sheets now.

The content is tailored to suit both clinicians and the public to facilitate effective communication and medical decision making. The AAN and MS Coalition members all have a stake in ensuring their constituencies receive the most accurate drug information, given there are a large number of competing information sources.

For more information, contact emergingtherapies@ms-coalition.org.

MS DRUG NATALIZUMAB RISK WARNING UPDATED

The Multiple Sclerosis Emerging Therapies Collaborative has published information sheets on an FDA-approved label update announcing additional serious adverse event risks with the multiple sclerosis (MS) medication natalizumab (Tysabri), specifically meningitis and encephalitis due to herpes simplex and varicella-zoster virus, as well as liver failure. The black box warning now includes the known risk factors for the development of progressive multifocal leukoencephalopathy. In addition, the indication no longer states that the medication is generally recommended for those who have responded inadequately to or are unable to tolerate alternate MS therapy.

The content is tailored to suit both clinicians and the public to facilitate effective communication and medical decision making. The AAN and MS Coalition members all have a stake in ensuring their constituencies receive the most accurate drug information, given there are a large number of competing information sources.

For more information, contact emergingtherapies@ms-coalition.org.

MS DRUG GLATIRAMER ACETATE FDA LABEL UPDATED

The Multiple Sclerosis Emerging Therapies Collaborative has published information sheets for clinicians and the public on the FDA-approved label update for glatiramer acetate (Copaxone). The dosing schedule now includes a new 40-mg-per-mL three-times-per-week dosing option in addition to the existing 20-mg-per-mL daily option. Information about the known post-injection reaction has been expanded.

The content is tailored to suit both clinicians and the public to facilitate effective communication and medical decision making. The AAN and MS Coalition members all have a stake in ensuring their constituencies receive the most accurate drug information, given there are a large number of competing information sources. For more information, contact emergingtherapies@ms-coalition.org.

Free FDA Email Alert Notifications for AAN Members

Sign up for PDR Drug Alerts, a free online service for AAN members that delivers timely neurology-specific FDA-mandated patient safety drug alerts electronically. This patient safety benefit is free to AAN members, but sign-up is necessary. Search and read all current or past MedWatch FDA safety information.

Benefits

The PDR Drug Alerts delivers FDA-required drug alerts for recalls and warnings to physicians and prescribers online.

  • Stay current on specialty-specific FDA alerts and provide the safest and best possible care for your patients.
  • Alerts are targeted by specialty-not all doctors get all alerts, so you can expect to receive less than one alert per week, on average.
  • Alerts are emailed immediately from the FDA-no delays in receiving urgent news.
  • All the largest pharmaceutical firms are engaged with PDR Drug Alerts.
  • Convenient vehicle for forwarding appropriate warnings to patients.
  • Improves patient safety and reduces physician liability.
  • Endorsed by major liability carriers and medical societies.
  • No paper or mailbox clutter.

You can have a copy of the alerts sent to up to three additional office staff, such as a nurse or receptionist.

Delivery is guaranteed-if you don't open the email within 72 hours, this will trigger a postal delivery of the information.

Get Started Receiving Your Free FDA Alerts
Sign-up by filling out the PDR Drug Alerts Physician Registration Form.

Note: Participants may opt out at any time. 

Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national passive surveillance system that monitors the safety of all vaccines licensed for use in the United States.

Reporting to VAERS
Health care providers are required by federal law to report certain adverse events after vaccination, even if it's uncertain that a vaccine was at fault.

Reports can be submitted by anyone, including health care providers, patients, or family members.
Accessing VAERS Data
VAERS reports are available through CDC WONDER. All personal identifying information is removed prior to posting the public data.
Limitations of VAERS
A report to VAERS generally does not conclude that a vaccine caused an adverse event. It only confirms that the adverse event happened sometime after a vaccine was received.

If a patient believes they have a serious adverse event following a vaccination, they should seek help from their health care provider.

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